Annex I

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Austria Abbott GmbH Ibuprofen Brufen 400 mg - 400 mg Film-coated tablet Oral use Perfektastasse 84a Filmtabletten 1230 Wien Austria Austria Abbott GmbH Ibuprofen Brufen 600 mg - 600 mg Film-coated tablet Oral use Perfektastasse 84a Filmtabletten 1230 Wien Austria Austria Merz Consumer Care Austria Ibuprofen Dismenol forte 400 mg Film-coated tablet Oral use GmbH Ibuprofen 400 mg Guglgasse 17 Filmtabletten 1110 Wien Austria Austria Merz Consumer Care Austria Ibuprofen Dismenol Ibuprofen 200 200 mg Film-coated tablet Oral use GmbH mg Filmtabletten Guglgasse 17 1110 Wien Austria Austria Reckitt Benckiser Ibuprofen natrium Nurofen 400 mg 400 mg Coated tablet Oral use Deutschland GmbH überzogene Tabletten Theodor Heuss Anlage 68165 Mannheim Germany Austria Reckitt Benckiser Ibuprofen Nurofen Liquid 200 mg 200 mg Capsule, soft Oral use Deutschland GmbH Kapseln Theodor Heuss Anlage 68165 Mannheim Germany

2

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Austria Sanova Pharma GmbH Ibuprofen Dolgit 800 mg - 800 mg Film-coated tablet Oral use Haidestraße 4 Filmtabletten 1110 Wien Austria Austria Sanova Pharma GmbH Ibuprofen Dolgit 200 mg - 200 mg Coated tablet Oral use Haidestraße 4 Dragees 1110 Wien Austria Austria Sanova Pharma GmbH Ibuprofen Dolgit 600 mg - 600 mg Coated tablet Oral use Haidestraße 4 Dragees 1110 Wien Austria Austria Sanova Pharma GmbH Ibuprofen Dolgit 400 mg - 400 mg Coated tablet Oral use Haidestraße 4 Dragees 1110 Wien Austria Austria Sanova Pharma GmbH Ibuprofen Dolgit 400 mg - 400 mg Capsule, soft Oral use Haidestraße 4 Kapseln 1110 Wien Austria Austria Bayer Austria GmbH Ibuprofen Aktren 400 mg - 400 mg Capsule, soft Oral use Herbststraße 6-10 Kapseln 1160 Wien Austria Austria Astellas Pharma GmbH Ibuprofen Dolofort 400 mg - 400 mg Film-coated tablet Oral use Linzer Straße221 E02 Filmtabletten 1140 Wien Austria

3

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Austria Reckitt Benckiser Ibuprofen Nurofen Meltlets Mint 200 mg Orodispersible tablet Oral use Deutschland GmbH 200 mg Theodor Heuss Anlage Schmelztabletten 68165 Mannheim Germany Austria Reckitt Benckiser Ibuprofen Nurofen Meltlets 200 200 mg Orodispersible tablet Oral use Deutschland GmbH mg Schmelztabletten Theodor Heuss Anlage 68165 Mannheim Germany Austria Abbott GmbH Ibuprofen Brufen 400 mg 400 mg Effervescent granules Oral use Perfektastasse 84a Brausegranulat 1230 Wien Austria Austria Boehringer Ingelheim Ibuprofen BoxaGrippal 200 mg/30 200 mg Film-coated tablet Oral use International GmbH mg - Filmtabletten 30 mg Binger Straße 173 55216 Ingelheim am Rhein Germany Austria Sigmapharm Arzneimittel Ibuprofen ib-u-ron 75 mg 75 mg Suppository Rectal use GmbH Zäpfchen Leystraße 129 1200 Wien Austria

4

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Austria Reckitt Benckiser Ibuprofen Nurofen rapid 200 mg 200 mg Capsule, soft Oral use Deutschland GmbH Weichkapseln Theodor Heuss Anlage 68165 Mannheim Germany Austria Sigmapharm Arzneimittel Ibuprofen ib-u-ron 150 mg 150 mg Suppository Rectal use GmbH Zäpfchen Leystraße 129 1200 Wien Austria Austria Actavis Group PTC ehf Ibuprofen Ibunin 200 mg 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 Filmtabletten 220 Hafnarfjörður Iceland Austria Actavis Group PTC ehf Ibuprofen Ibunin 400 mg 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 Filmtabletten 220 Hafnarfjörður Iceland Austria Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 400 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 mg Filmtabletten 220 Hafnarfjörður Iceland Austria Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 600 600 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 mg Filmtabletten 220 Hafnarfjörður Iceland

5

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Austria Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 200 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 mg Filmtabletten 220 Hafnarfjörður Iceland Austria Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 800 800 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 mg Filmtabletten 220 Hafnarfjörður Iceland Austria Abbott GmbH Ibuprofen Ibuprofen Rockspring 200 mg Effervescent granules Oral use Perfektastasse 84a 200 mg Brausegranulat 1230 Wien Austria Austria Genericon Pharma GmbH Ibuprofen Ibuprofen Genericon 400 mg Film-coated tablet Oral use Hafnerstraße 211 400 mg Filmtabletten 8054 Graz Austria Austria Gebro Pharma GmbH Ibuprofen Dexibuprofen Gebro 300 mg Powder for oral Oral use Bahnhofbichl 13 300 mg Pulver zur suspension 6391 Fieberbrunn Herstellung einer Austria Suspension zum Einnehmen Austria Gebro Pharma GmbH Ibuprofen Dexibuprofen Gebro 400 mg Powder for oral Oral use Bahnhofbichl 13 400 mg Pulver zur suspension 6391 Fieberbrunn Herstellung einer Austria Suspension zum Einnehmen

6

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Austria Takeda Austria GmbH Ibuprofen Ibumetin 200 mg - 200 mg Coated tablet Oral use St. Peter Straße 25 Dragees 4020 Linz Austria Austria Takeda Austria GmbH Ibuprofen Ibumetin forte 400 mg 400 mg Film-coated tablet Oral use St. Peter Straße 25 - Filmtabletten 4020 Linz Austria Austria ratiopharm Arzneimittel Ibuprofen WICK DayMed Duo 200 200 mg Film-coated tablet Oral use Vertriebs-GmbH mg/30 mg 30 mg Albert Schweitzer Gasse 3 Filmtabletten 1140 Wien Austria Austria Reckitt Benckiser Ibuprofen Nurofen 200 mg - 200 mg Coated tablet Oral use Deutschland GmbH Dragees Theodor Heuss Anlage 68165 Mannheim Germany Austria Kwizda Pharma GmbH Ibuprofen Adolorin Ibuforte 400 400 mg Coated tablet Oral use Effingergasse 21 mg Dragees 1160 Wien Austria Austria ratiopharm Arzneimittel Ibuprofen Ibuprofen ratiopharm 4 40 mg/ml Syrup Oral use Vertriebs-GmbH % Sirup für Kinder Albert Schweitzer Gasse 3 1140 Wien Austria

7

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Austria Genericon Pharma GmbH Ibuprofen Ibuprofen Genericon 600 mg Film-coated tablet Oral use Hafnerstraße 211 600 mg Filmtabletten 8054 Graz Austria Austria Boehringer Ingelheim Ibuprofen Thomaprodol 400 mg - 400 mg Capsule, soft Oral use International GmbH Weichkapseln Binger Straße 173 55216 Ingelheim am Rhein Germany Austria G.L. Pharma GmbH Ibuprofen Ibuprofen G.L. 400 mg 400 mg Film-coated tablet Oral use Schloßplatz 1 - Filmtabletten 8502 Lannach Austria Austria G.L. Pharma GmbH Ibuprofen Ibuprofen G.L. 600 mg 600 mg Film-coated tablet Oral use Schloßplatz 1 - Filmtabletten 8502 Lannach Austria Austria Reckitt Benckiser Ibuprofen Nurofen rapid 400 mg 400 mg Capsule, soft Oral use Deutschland GmbH Weichkapseln Theodor Heuss Anlage 68165 Mannheim Germany Austria Gebro Pharma GmbH Dexibuprofen Seractil forte 400 mg - 400 mg Film-coated tablet Oral use Bahnhofbichl 13 Filmtabletten 6391 Fieberbrunn Austria

8

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Austria Gebro Pharma GmbH Dexibuprofen Seractil 200 mg - 200 mg Film-coated tablet Oral use Bahnhofbichl 13 Filmtabletten 6391 Fieberbrunn Austria Austria Gebro Pharma GmbH Dexibuprofen Seractil 300 mg - 300 mg Film-coated tablet Oral use Bahnhofbichl 13 Filmtabletten 6391 Fieberbrunn Austria Austria Gebro Pharma GmbH Dexibuprofen Eu-Med 200 mg 200 mg Tablet Oral use Bahnhofbichl 13 Schmerztabletten 6391 Fieberbrunn Austria Austria Gebro Pharma GmbH Dexibuprofen Monactil 200 mg - 200 mg Film-coated tablet Oral use Bahnhofbichl 13 Filmtabletten 6391 Fieberbrunn Austria Austria Gebro Pharma GmbH Dexibuprofen Atriscal 200 mg - 200 mg Film-coated tablet Oral use Bahnhofbichl 13 Filmtabletten 6391 Fieberbrunn Austria Austria Gebro Pharma GmbH Dexibuprofen Atriscal 300 mg - 300 mg Film-coated tablet Oral use Bahnhofbichl 13 Filmtabletten 6391 Fieberbrunn Austria Austria Gebro Pharma GmbH Dexibuprofen Atriscal 400 mg - 400 mg Film-coated tablet Oral use Bahnhofbichl 13 Filmtabletten 6391 Fieberbrunn Austria

9

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Austria Gebro Pharma GmbH Dexibuprofen Dexibuprofen "Gebro" 200 mg Film-coated tablet Oral use Bahnhofbichl 13 200 mg - Filmtabletten 6391 Fieberbrunn Austria Austria Gebro Pharma GmbH Dexibuprofen Dexibuprofen "Gebro" 300 mg Film-coated tablet Oral use Bahnhofbichl 13 300 mg - Filmtabletten 6391 Fieberbrunn Austria Austria Gebro Pharma GmbH Dexibuprofen Dexibuprofen "Gebro" 400 mg Film-coated tablet Oral use Bahnhofbichl 13 400 mg - Filmtabletten 6391 Fieberbrunn Austria Austria Gebro Pharma GmbH Dexibuprofen Movone 200 mg - 200 mg Film-coated tablet Oral use Bahnhofbichl 13 Filmtabletten 6391 Fieberbrunn Austria Austria Gebro Pharma GmbH Dexibuprofen Movone 300 mg - 300 mg Film-coated tablet Oral use Bahnhofbichl 13 Filmtabletten 6391 Fieberbrunn Austria Austria Gebro Pharma GmbH Dexibuprofen Movone 400 mg - 400 mg Film-coated tablet Oral use Bahnhofbichl 13 Filmtabletten 6391 Fieberbrunn Austria Belgium Pfizer bv Ibuprofen Advil 200 200 mg Effervescent tablet Oral use Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

10

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Belgium BGP Products Belgium Ibuprofen Brufen 40 mg/ml Oral suspension Oral use Avenue Einstein 12 1300 Wavre Belgium Belgium BGP Products Belgium Ibuprofen Brufen 400 400 mg Coated tablet Oral use Avenue Einstein 12 1300 Wavre Belgium Belgium BGP Products Belgium Ibuprofen Brufen Forte 600 600 mg Film-coated tablet Oral use Avenue Einstein 12 1300 Wavre Belgium Belgium BGP Products Belgium Ibuprofen Brufen Granules 600 600 mg Granules for oral Oral use Avenue Einstein 12 solution 1300 Wavre Belgium Belgium BGP Products Belgium Ibuprofen Brufen Retard 800 800 mg Prolonged-release Oral use Avenue Einstein 12 tablet 1300 Wavre Belgium Belgium BGP Products Belgium Ibuprofen Brufen Granules 400 mg Effervescent granules Oral use Avenue Einstein 12 1300 Wavre Belgium Belgium Teva Pharma Belgium N.V. Ibuprofen Buprophar 200 mg Coated tablet Oral use Laarstraat 16 2610 Wilrijk Belgium

11

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Belgium Teva Pharma Belgium N.V. Ibuprofen Buprophar 400 mg Coated tablet Oral use Laarstraat 16 2610 Wilrijk Belgium Belgium Socobom nv Ibuprofen Dolofin 400 mg Coated tablet Oral use Louizalaan 149 bus 24 1050 Brussel Belgium Belgium Laboratoria Qualiphar Ibuprofen Extrapan Ibruprofenum 200 mg Coated tablet Oral use N.V./S.A. 200 mg Rijksweg 9 2880 Bornem Belgique Belgium Laboratoria Qualiphar Ibuprofen Extrapan Ibruprofenum 400 mg Coated tablet Oral use N.V./S.A. 400 mg Rijksweg 9 2880 Bornem Belgique Belgium Laboratoires Belges Ibuprofen Ibumed 200 mg 200 mg Tablet Oral use Pharmacobel SA Avenue de Scheut 48 1070 Bruxelles Belgique Belgium Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 200 200 mg Coated tablet Oral use Reykjavíkurvegi 76-78 mg 220 Hafnarfjörður Iceland

12

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Belgium Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 400 400 mg Coated tablet Oral use Reykjavíkurvegi 76-78 mg 220 Hafnarfjörður Iceland Belgium Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 600 600 mg Coated tablet Oral use Reykjavíkurvegi 76-78 mg 220 Hafnarfjörður Iceland Belgium Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 800 800 mg Coated tablet Oral use Reykjavíkurvegi 76-78 mg 220 Hafnarfjörður Iceland Belgium Boehringer Ingelheim Ibuprofen Ibuprofen Boehringer 400 mg Capsule Oral use International GmbH Ingelheim 400 mg Binger Straße 173 55216 Ingelheim am Rhein Germany Belgium Eurogenerics Afgekort "E.G." Ibuprofen Ibuprofen EG 200 mg 200 mg Coated tablet Oral use Heizel Esplanade b22 1020 Laken Belgium Belgium Eurogenerics Afgekort "E.G." Ibuprofen Ibuprofen EG 40 mg/ml 40 mg/ml Oral suspension Oral use Heizel Esplanade b22 1020 Laken Belgium

13

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Belgium Eurogenerics Afgekort "E.G." Ibuprofen Ibuprofen EG 400 mg 400 mg Coated tablet Oral use Heizel Esplanade b22 1020 Laken Belgium Belgium Eurogenerics Afgekort "E.G." Ibuprofen sodium Ibuprofen EG 400 mg 512 mg Effervescent tablet Oral use Heizel Esplanade b22 hydrate 1020 Laken Belgium Belgium Eurogenerics Afgekort "E.G." Ibuprofen Ibuprofen EG 600 mg 600 mg Coated tablet Oral use Heizel Esplanade b22 1020 Laken Belgium Belgium Eurogenerics Afgekort "E.G." Ibuprofen Ibuprofen EG 800 mg 800 mg Tablet Oral use Heizel Esplanade b22 1020 Laken Belgium Belgium Mylan bvba/sprl Ibuprofen lysine Ibuprofen Lysine Mylan 342 mg Coated tablet Oral use Terhulpsesteenweg 6a 200 mg 1560 Hoeilaart Belgium Belgium Mylan bvba/sprl Ibuprofen lysine Ibuprofen Lysine Mylan 684 mg Coated tablet Oral use Terhulpsesteenweg 6a 400 mg 1560 Hoeilaart Belgium Belgium Mylan bvba/sprl Ibuprofen lysine Ibuprofen Lysine Mylan 342 mg Coated tablet Oral use Terhulpsesteenweg 6a Pharma 200 mg 1560 Hoeilaart Belgium

14

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Belgium Mylan bvba/sprl Ibuprofen lysine Ibuprofen Lysine Mylan 684 mg Coated tablet Oral use Terhulpsesteenweg 6a Pharma 400 mg 1560 Hoeilaart Belgium Belgium Boehringer Ingelheim Ibuprofen Ibuprofen 200 mg Coated tablet Oral use International GmbH pseudoephedrine Pseudoéphedrine HCL 30 mg Binger Straße 173 hydrochloride Boehringer Ingelheim 55216 Ingelheim am Rhein 200 mg -30 mg Germany Belgium Sandoz nv/sa Ibuprofen Ibuprofen Sandoz 200 200 mg Coated tablet Oral use Telecom Gardens mg Medialaan 40 1800 Vilvoorde Belgium Belgium Sandoz nv/sa Ibuprofen Ibuprofen Sandoz 40 40 mg/ml Oral suspension Oral use Telecom Gardens mg/ml Medialaan 40 1800 Vilvoorde Belgium Belgium Sandoz nv/sa Ibuprofen Ibuprofen Sandoz 400 400 mg Coated tablet Oral use Telecom Gardens mg Medialaan 40 1800 Vilvoorde Belgium

15

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Belgium Sandoz nv/sa Ibuprofen Ibuprofen Sandoz 600 600 mg Coated tablet Oral use Telecom Gardens mg Medialaan 40 1800 Vilvoorde Belgium Belgium Sandoz nv/sa Ibuprofen Ibuprofen Sandoz 800 800 mg Coated tablet Oral use Telecom Gardens mg Medialaan 40 1800 Vilvoorde Belgium Belgium Teva Pharma Belgium N.V. Ibuprofen Ibuprofen Teva 200 mg 200 mg Coated tablet Oral use Laarstraat 16 2610 Wilrijk Belgium Belgium Teva Pharma Belgium N.V. Ibuprofen Ibuprofen Teva 400 mg 400 mg Coated tablet Oral use Laarstraat 16 2610 Wilrijk Belgium Belgium Teva Pharma Belgium N.V. Ibuprofen Ibuprofen Teva 600mg 600 mg Tablet Oral use Laarstraat 16 2610 Wilrijk Belgium Belgium Rockspring Healthcare Ibuprofen Ibuprofen/Codeine 400 mg Coated tablet Oral use Limited codeine phosphate Phosphate Hemihydrate 30 mg 38/40 Chamberlayne Road hemihydrate Rockspring London NW10 3JE 400mg/30mg United Kingdom

16

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Belgium Actavis Group PTC ehf Ibuprofen Ifenin 200mg 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Belgium Actavis Group PTC ehf Ibuprofen Ifenin 400mg 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Belgium BGP Products Belgium Ibuprofen Malafene 100mg/5ml 20 mg/ml Syrup Oral use Avenue Einstein 12 1300 Wavre Belgium Belgium Reckitt Benckiser Ibuprofen Nurofen 200 200 mg Coated tablet Oral use (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium Belgium Reckitt Benckiser Ibuprofen Nurofen 200 fastcaps 200 mg Capsule, soft Oral use (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium Belgium Reckitt Benckiser Ibuprofen Nurofen 200 fastsodium 200 mg Coated tablet Oral use (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

17

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Belgium Reckitt Benckiser Ibuprofen Nurofen 400 400 mg Coated tablet Oral use (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium Belgium Reckitt Benckiser Ibuprofen Nurofen 400 fastcaps 400 mg Capsule, soft Oral use (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium Belgium Reckitt Benckiser Ibuprofen Nurofen 400 fastpowder 400 mg Powder for oral Oral use (Healthcare) -SA/NV solution Researchdreef 20 1070 Brussels Belgium Belgium Reckitt Benckiser Ibuprofen Nurofen 400 fastsodium 400 mg Coated tablet Oral use (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium Belgium Reckitt Benckiser Ibuprofen lysine Nurofen 400 fasttabs 684 mg Film-coated tablet Oral use (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

18

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Belgium Reckitt Benckiser Ibuprofen Nurofen fastsodium 200 mg Coated tablet Oral use (Healthcare) -SA/NV voor kinderen vanaf 12 Researchdreef 20 jaar 200mg 1070 Brussels Belgium Belgium Reckitt Benckiser Ibuprofen lysine Nurofen Lysine 200 mg 342 mg Film-coated tablet Oral use (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium Belgium Reckitt Benckiser Ibuprofen lysine Nurofen Lysine 400 mg 684 mg Film-coated tablet Oral use (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium Belgium Reckitt Benckiser Ibuprofen Nurofen Smelttabletten 200 mg Orodispersible tablet Oral use (Healthcare) -SA/NV 200 mg Researchdreef 20 1070 Brussels Belgium Belgium Reckitt Benckiser Ibuprofen Nurofen voor kinderen 200 mg Coated tablet Oral use (Healthcare) -SA/NV vanaf 12 jaar 200 mg Researchdreef 20 1070 Brussels Belgium

19

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Belgium Omega Pharma Belgium NV Ibuprofen Optalidon 200 Nieuw 200 mg Coated tablet Oral use Industriepark "De Prijkels" formule Venecoweg 26 9810 Nazareth Belgium Belgium Omega Pharma Belgium NV Ibuprofen Optalidon 400 Nieuw 400 mg Coated tablet Oral use Industriepark "De Prijkels" formule Venecoweg 26 9810 Nazareth Belgium Belgium Johnson & Johnson Ibuprofen lysine Perdofemina 400mg 684 mg Film-coated tablet Oral use Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium Belgium Johnson & Johnson Ibuprofen lysine Perrdophen 400mg 684 mg Coated tablet Oral use Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium Belgium Johnson & Johnson Ibuprofen lysine Perdotensio 200mg 342 mg Film-coated tablet Oral use Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium

20

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Belgium Zambon SA/NV Ibuprofen Spidifen 200 mg 200 mg Granules for oral Oral use E.Demunterlaan 1/9 solution 1090 Brussels Belgium Belgium Zambon SA/NV Ibuprofen Spidifen 200 mg 200 mg Tablet Oral use E.Demunterlaan 1/9 1090 Brussels Belgium Belgium Zambon SA/NV Ibuprofen Spidifen 200 mg 200 mg Effervescent tablet Oral use E.Demunterlaan 1/9 1090 Brussels Belgium Belgium Zambon SA/NV Ibuprofen Spidifen 400 mg 400 mg Film-coated tablet Oral use E.Demunterlaan 1/9 1090 Brussels Belgium Belgium Zambon SA/NV Ibuprofen Spidifen 400 mg 400 mg Granules for oral Oral use E.Demunterlaan 1/9 solution 1090 Brussels Belgium Bulgaria Alvogen IPCo S.àr.l. Ibuprofen Alvofen Express 200 mg Capsule, soft Oral use Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg Bulgaria Alvogen IPCo S.àr.l. Ibuprofen Alvofen Express 400 mg Capsule, soft Oral use Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

21

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Bulgaria Ecopharm Group AD Ibuprofen Doloren 200 mg Film-coated tablet Oral use Cherni Vah blvd., bl. 3 1421 Sofia Bulgaria Bulgaria Ecopharm Group AD Ibuprofen Doloren 400 mg Film-coated tablet Oral use Cherni Vah blvd., bl. 3 1421 Sofia Bulgaria Bulgaria Zentiva, k.s. Ibuprofen Extralgin 200 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Bulgaria Zentiva, k.s. Ibuprofen Extralgin 400 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Bulgaria Zentiva, k.s. Ibuprofen Extralgin Gold 200 mg Film-coated tablet Oral use U kabelovny 130 30 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Bulgaria STADA Arzneimittel AG Ibuprofen Flexistad 400 mg Film-coated tablet Oral use Stadastr. 2-18 61118 Bad Vilbel Germany

22

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Bulgaria STADA Arzneimittel AG Ibuprofen Flexistad 600 mg Film-coated tablet Oral use Stadastr. 2-18 61118 Bad Vilbel Germany Bulgaria STADA Arzneimittel AG Ibuprofen Flexistad 800 mg Film-coated tablet Oral use Stadastr. 2-18 61118 Bad Vilbel Germany Bulgaria Tchaikapharma Highquality Ibuprofen Ibufen 200 mg Effervescent tablet Oral use Medicines 1 G. M. Dimitrov Blvd Sofia, 1172 Bulgaria Bulgaria Actavis Group PTC ehf Ibuprofen Ibudolor 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Bulgaria Actavis Group PTC ehf Ibuprofen Ibudolor 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Bulgaria Actavis EAD Ibuprofen Ibudolor 300 mg Prolonged-release Oral use Atanas Dukov str. 29 capsule, hard 1407 Sofia Bulgaria

23

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Bulgaria US Pharmacia Sp. z o.o. Ibuprofen Ibuprom 200 mg Coated tablet Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd Bulgaria US Pharmacia Sp. z o.o. Ibuprofen Ibuprom Sprint MAX 400 mg Capsule, soft Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd Bulgaria US Pharmacia Sp. z o.o. Ibuprofen Ibuprom Sprint Caps 200 mg Capsule, soft Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd Bulgaria US Pharmacia Sp. z o.o. Ibuprofen Ibuprom Max 400 mg Coated tablet Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd Bulgaria US Pharmacia Sp. z o.o. Ibuprofen Ibuprom Sinus 200 mg Coated tablet Oral use Ziebicka st. 40 pseudoephedrine 30 mg 50-507 Wroclaw hydrochloride Poalnd Bulgaria Abbott Products EOOD Ibuprofen Brufen 200 mg Effervescent tablet Oral use 48 Sitnyakovo blvd, Serdika offices 1505 Sofia Bulgaria

24

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Bulgaria Abbott Products EOOD Ibuprofen Brufen Codeine 400 mg Film-coated tablet Oral use 48 Sitnyakovo blvd, Serdika codeine phosphate 30 mg offices hemihydrate 1505 Sofia Bulgaria Bulgaria Abbott Scandinavia AB Ibuprofen Brufen 20 mg/ml Oral suspension Oral use P.O Box 1498 SE-171 29 Solna Sweden Bulgaria Abbott Scandinavia AB Ibuprofen Brufen Forte 40 mg/ml Oral suspension Oral use P.O Box 1498 SE-171 29 Solna Sweden Bulgaria Abbott Scandinavia AB Ibuprofen Brufen 400 mg Effervescent granules Oral use P.O Box 1498 SE-171 29 Solna Sweden Bulgaria Abbott Scandinavia AB Ibuprofen Brufen retard 800 mg Prolonged-release Oral use P.O Box 1498 tablet SE-171 29 Solna Sweden Bulgaria Pabianickie Zakłady Ibuprofen Ibuprofen Polfa 200 mg Coated tablet Oral use Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland

25

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Bulgaria Berlin-Chemie AG Ibuprofen MIG-400 400 mg Film-coated tablet Oral use Glienicker Weg 125 12489 Berlin Germany Bulgaria Pharmaceutical plants Milve Ibuprofen Milorofen 200 mg Film-coated tablet Oral use Ltd. 33 Nikola Mirchev 1113 Sofia Bulgaria Bulgaria Reckitt Benckiser Healthcare Ibuprofen Nurofen Express Forte 400 mg Capsule, soft Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Bulgaria Reckitt Benckiser Healthcare Ibuprofen Nurofen Forte 400 mg Coated tablet Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Bulgaria Reckitt Benckiser Healthcare Ibuprofen Nurofen Active 200 mg Orodispersible tablet Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

26

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Bulgaria Reckitt Benckiser Healthcare Ibuprofen Nurofen 200 mg Coated tablet Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Bulgaria Reckitt Benckiser Healthcare Ibuprofen sodium Nurofen Femina Forte 512 mg Coated tablet Oral use International Limited dihydrate Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Bulgaria Reckitt Benckiser Healthcare Ibuprofen Nurofen STOPCOLD 200 mg Film-coated tablet Oral use International Limited pseudoephedrine 30 mg Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Bulgaria Reckitt Benckiser Healthcare Ibuprofen sodium Nurofen X2 256 mg Coated tablet Oral use International Limited dihydrate Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

27

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Bulgaria Reckitt Benckiser Healthcare Ibuprofen lysine Nurofen Migraine Pain 342 mg Film-coated tablet Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Bulgaria Reckitt Benckiser Healthcare Ibuprofen Nurofen Express 200 mg Capsule, soft Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Bulgaria Boehringer Ingelheim Ibuprofen Mucogrip 200 mg Film-coated tablet Oral use International GmbH pseudoephedrine 30 mg Binger Straße 173 55216 Ingelheim am Rhein Germany Bulgaria Zentiva, k.s. Ibuprofen Ibalgin Fast 400 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Croatia Berlin-Chemie Menarini Ibuprofen Berlistar forte 40 40 mg/ml Oral suspension Oral use Hrvatska d.o.o. mg/ml oralna Horvatova 80a, Zagreb suspenzija 10000 Croatia

28

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Croatia Alkaloid d.o.o., Ibuprofen BlokMax Lady 200 mg 200 mg Film-coated tablet Oral use Ulica grada Vukovara 226f filmom obložene tablete Zagreb 10000 Croatia Croatia Abbott Laboratories d.o.o. Ibuprofen Brufen 400 mg filmom 400 mg Film-coated tablet Oral use Koranska 2 obložene tablete Zagreb 10000 Croatia Croatia Abbott Laboratories d.o.o. Ibuprofen Brufen 400 mg šumeće 400 mg Effervescent granules Oral use Koranska 2 granule Zagreb 10000 Croatia Croatia Abbott Laboratories d.o.o. Ibuprofen Brufen 600 mg filmom 600 mg Film-coated tablet Oral use Koranska 2 obložene tablete Zagreb 10000 Croatia Croatia Abbott Laboratories d.o.o. Ibuprofen Brufen 600 mg šumeće 600 mg Effervescent granules Oral use Koranska 2 granule Zagreb 10000 Croatia Croatia Abbott Laboratories d.o.o. Ibuprofen Brufen Effect 200 mg 200 mg Effervescent granules Oral use Koranska 2 šumeće granule Zagreb 10000 Croatia Croatia Abbott Laboratories d.o.o. Ibuprofen Brufen Effect 400 mg 400 mg Effervescent granules Oral use Koranska 2 šumeće granule Zagreb 10000 Croatia

29

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Croatia Abbott Laboratories d.o.o. Ibuprofen Brufen forte 40 mg/ml 40 mg/ml Oral suspension Oral use Koranska 2 oralna suspenzija Zagreb 10000 Croatia Croatia Abbott Laboratories d.o.o. Ibuprofen Brufen SR 800 mg 800 mg Film-coated Oral use Koranska 2 tablete s produljenim prolonged-release Zagreb 10000 oslobađanjem tablet Croatia Croatia Abbott Laboratories d.o.o. Ibuprofen Dalsy forte 40 mg/ml 40 mg/ml Oral suspension Oral use Koranska 2 oralna suspenzija Zagreb 10000 Croatia Croatia Abbott Laboratories d.o.o. Ibuprofen Dalsy sirup 20 mg/ml Syrup Oral use Koranska 2 Zagreb 10000 Croatia Croatia Fidifarm d.o.o. Ibuprofen Fidiprofen 200 mg 200 mg Effervescent tablet Oral use Obrtnička 37, Rakitje šumeće tablete Brestovje 10437 Croatia Croatia Fidifarm d.o.o. Ibuprofen Fidiprofen flu 200 mg + 200 mg Tablet Oral use Obrtnička 37, Rakitje pseudoephedrine 30 mg tablete 30 mg Brestovje 10437 Croatia

30

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Croatia sanofi-aventis Croatia Ibuprofen Ibalgin 400 mg filmom 400 mg Film-coated tablet Oral use d.o.o., obložene tablete Heinzelova 70 Zagreb 10000 Croatia Croatia sanofi-aventis Croatia Ibuprofen Ibalgin Rapid 400 mg 400 mg Film-coated tablet Oral use d.o.o., filmom obložene tablete Heinzelova 70 Zagreb 10000 Croatia Croatia PharmaS d.o.o., Ibuprofen IbuPhar 600 mg filmom 600 mg Film-coated tablet Oral use Radnička cesta 47 obložene tablete Zagreb 10000 Croatia Croatia PharmaS d.o.o., Ibuprofen Ibuprofen PharmaS 200 200 mg Film-coated tablet Oral use Radnička cesta 47 mg filmom obložene Zagreb 10000 tablete Croatia Croatia PharmaS d.o.o., Ibuprofen Ibuprofen PharmaS 400 400 mg Film-coated tablet Oral use Radnička cesta 47 mg filmom obložene Zagreb 10000 tablete Croatia Croatia Belupo, lijekovi i kozmetika Ibuprofen Ibuprofen 100 mg/5 ml 20 mg/ml Oral suspension Oral use d.d. oralna suspenzija Ulica Danica 5 Koprivnica 48000 Croatia

31

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Croatia Belupo, lijekovi i kozmetika Ibuprofen Ibuprofen 400 mg 400 mg Film-coated tablet Oral use d.d. filmom obložene tablete Ulica Danica 5 Koprivnica 48000 Croatia Croatia Belupo, lijekovi i kozmetika Ibuprofen Ibuprofen 600 mg 600 mg Film-coated tablet Oral use d.d. filmom obložene tablete Ulica Danica 5 Koprivnica 48000 Croatia Croatia Belupo, lijekovi i kozmetika Ibuprofen Ibuprofen Belupo 800 800 mg Film-coated tablet Oral use d.d. mg filmom obložene Ulica Danica 5 tablete Koprivnica 48000 Croatia Croatia Belupo, lijekovi i kozmetika Ibuprofen Neofen 100 mg/5 ml 20 mg/ml Syrup Oral use d.d. sirup Ulica Danica 5 Koprivnica 48000 Croatia Croatia Belupo, lijekovi i kozmetika Ibuprofen Neofen 200 mg filmom 200 mg Film-coated tablet Oral use d.d. obložene tablete Ulica Danica 5 Koprivnica 48000 Croatia

32

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Croatia Belupo, lijekovi i kozmetika Ibuprofen Neofen Direkt 200 mg 200 mg Orodispersible tablet Oral use d.d. raspadljive tablete za Ulica Danica 5 usta Koprivnica 48000 Croatia Croatia Belupo, lijekovi i kozmetika Ibuprofen Neofen Forte 400 mg 400 mg Film-coated tablet Oral use d.d. filmom obložene tablete Ulica Danica 5 Koprivnica 48000 Croatia Croatia Farmal d.d. Ibuprofen Ibuprofen Farmal 200 200 mg Film-coated tablet Oral use Branitelja domovinskog rata mg filmom obložene 8, Ludbreg 42230 tablete Croatia Croatia Farmal d.d. Ibuprofen Ibuprofen Farmal 400 400 mg Film-coated tablet Oral use Branitelja domovinskog rata mg filmom obložene 8, Ludbreg 42230 tablete Croatia Croatia Farmal d.d. Ibuprofen Ibuprofen Farmal 600 600 mg Film-coated tablet Oral use Branitelja domovinskog rata mg filmom obložene 8, Ludbreg 42230 tablete Croatia Croatia Farmal d.d. Ibuprofen Ibuprofen Farmal 800 800 mg Prolonged-release Oral use Branitelja domovinskog rata mg tablete s tablet 8, Ludbreg 42230 produljenim Croatia oslobađanjem

33

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Croatia Berlin-Chemie Menarini Ibuprofen Ibustar 400 mg filmom 400 mg Film-coated tablet Oral use Hrvatska d.o.o. obložene tablete Horvatova 80a Zagreb 10000 Croatia Croatia Reckitt Benckiser d.o.o. Ibuprofen Nurofen 200 mg 200 mg Coated tablet Oral use Ulica grada Vukovara 269 D obložene tablete Zagreb 10000 Croatia Croatia Reckitt Benckiser d.o.o. Ibuprofen Nurofen Forte 400 mg 400 mg Coated tablet Oral use Ulica grada Vukovara 269 D obložene tablete Zagreb 10000 Croatia Croatia Reckitt Benckiser d.o.o. Ibuprofen Nurofen Cold and Flu 200 mg Film-coated tablet Oral use Ulica grada Vukovara 269 D pseudoephedrine 200 mg + 30 mg 40 mg Zagreb 10000 filmom obložene tablete Croatia Croatia Reckitt Benckiser d.o.o. Ibuprofen Nurofen Rapid 200 mg 200 mg Capsule, soft Oral use Ulica grada Vukovara 269 D meke kapsule Zagreb 10000 Croatia Croatia Reckitt Benckiser d.o.o. Ibuprofen Nurofen Rapid Forte 400 mg Capsule, soft Oral use Ulica grada Vukovara 269 D 400 mg meke kapsule Zagreb 10000 Croatia

34

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Croatia PharmaSwiss d.o.o. Ibuprofen Rapidol S 200 mg 200 mg Capsule, soft Oral use Miramarska 23 kapsula, meka Zagreb 10000 Croatia Croatia PharmaSwiss d.o.o. Ibuprofen Rapidol S 400 mg 400 mg Capsule, soft Oral use Miramarska 23 kapsula, meka Zagreb 10000 Croatia Croatia Jadran Galenski Laboratorij Ibuprofen Rhinorelief 200 mg + 200 mg Tablet Oral use d.d. pseudoephedrine 30 mg tablete 30 mg Svilno 20 Rijeka 10000 Croatia Cyprus Varnavas Hadjipanayis Ltd Ibuprofen Brufen 400 mg Film-coated tablet Oral use Yiannou Kranidioti Avenue 226 2234 Latsia Strovolos Cyprus Cyprus Remedica IP Ltd Ibuprofen Bulfan 200 mg Film-coated tablet Oral use Aharnon Street , Limassol Industrial Estate Limassol 3502 Cyprus

35

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Cyprus Remedica IP Ltd Ibuprofen Bulfan 400 mg Film-coated tablet Oral use Aharnon Street , Limassol Industrial Estate Limassol 3502 Cyprus Cyprus Reckitt Benckiser Hellas Ibuprofen Nurofen liquid capsule 200 mg Capsule, soft Oral use Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece Cyprus Reckitt Benckiser Hellas Ibuprofen Nurofen cold & flu 200 mg Film-coated tablet Oral use Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece Cyprus Reckitt Benckiser Hellas Ibuprofen Nurofen Express 400 mg Capsule, soft Oral use Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece Cyprus Lifepharma (Z.A.M) Ltd Ibuprofen sodium Nurofen Express 256 mg Tablet Oral use Agiou Nicolaou Street 8 dihydrate 1523 Lefkosia Cyprus

36

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Cyprus Lifepharma (Z.A.M) Ltd Ibuprofen sodium Nurofen Express 512 mg Tablet Oral use Agiou Nicolaou Street 8 dihydrate 1523 Lefkosia Cyprus Cyprus Reckitt Benckiser Hellas Ibuprofen Nurofen 200 mg Film-coated tablet Oral use Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece Cyprus Remedica Ltd Ibuprofen Perofen 200 mg Coated tablet Oral use Aharnon str Limassol Industrial Estate Limassol 3508 Cyprus Cyprus Remedica Ltd Ibuprofen Perofen 400 mg Coated tablet Oral use Aharnon str Limassol Industrial Estate Limassol 3508 Cyprus Cyprus Remedica Ltd Ibuprofen Perofen 200 mg Film-coated tablet Oral use Aharnon str Limassol Industrial Estate Limassol 3508 Cyprus

37

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Cyprus Remedica Ltd Ibuprofen Perofen 400 mg Film-coated tablet Oral use Aharnon str Limassol Industrial Estate Limassol 3508 Cyprus Cyprus Remedica Ltd Ibuprofen Perofen 600 mg Film-coated tablet Oral use Aharnon str Limassol Industrial Estate Limassol 3508 Cyprus Cyprus Medochemie Ltd Ibuprofen Rufan 200 mg Film-coated tablet Oral use 1-10 Constantinoupoleos str Limassol 3505 Cyprus Cyprus Medochemie Ltd Ibuprofen Rupan Femme 400 mg Film-coated tablet Oral use 1-10 Constantinoupoleos str Limassol 3505 Cyprus Cyprus Medochemie Ltd Ibuprofen Rupan Max 200 mg Film-coated tablet Oral use 1-10 Constantinoupoleos str Limassol 3505 Cyprus Cyprus Boehringer Ingelheim Ibuprofen Mucocold 200 mg Film-coated tablet Oral use International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

38

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Czech Pfizer Corporation Austria Ibuprofen Advil Rapid 400 mg Capsule, soft Oral use Republic GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria Czech Apotex Europe B.V. Ibuprofen Apo-ibuprofen 400 mg 400 mg Film-coated tablet Oral use Republic Darwinweg 20 2333 CR Leiden The Netherlands Czech Banner Pharmacaps Europe Ibuprofen Apo-ibuprofen Rapid 400 mg Capsule, soft Oral use Republic B.V. 400 mg soft capsules De Posthoornstraat 7 5048 AS Tilburg The Netherlands Czech Abbott Laboratories, s.r.o. Ibuprofen Brufen 400 400 mg Film-coated tablet Oral use Republic Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park Czech Republic Czech Abbott Laboratories, s.r.o. Ibuprofen Brufedol 400 mg 400 mg Effervescent granules Oral use Republic Evropská 2591/33d šumivé granule 160 00 Praha 6 - Hadovka Office Park Czech Republic

39

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Czech Abbott Laboratories, s.r.o. Ibuprofen Brufen 600 mg 600 mg Effervescent granules Oral use Republic Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park Czech Republic Czech Abbott Laboratories, s.r.o. Ibuprofen Brufen Retard 800 mg 800 mg Prolonged-release Oral use Republic Evropská 2591/33d tablet 160 00 Praha 6 - Hadovka Office Park Czech Republic Czech Abbott Laboratories, s.r.o. Ibuprofen Brufen Sirup 20 mg/ml Syrup Oral use Republic Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park Czech Republic Czech Dolorgiet GmbH & Co. KG Ibuprofen Dolgit 800 800 mg Film-coated tablet Oral use Republic Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany Czech Zentiva, k.s. Ibuprofen Ibalgin 200 200 mg Film-coated tablet Oral use Republic U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

40

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Czech Zentiva, k.s. Ibuprofen Ibalgin 400 400 mg Film-coated tablet Oral use Republic U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Czech Zentiva, k.s. Ibuprofen Ibalgin 600 600 mg Film-coated tablet Oral use Republic U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Czech Zentiva, k.s. Ibuprofen Ibalgin Grip 200 mg/5 200 mg Film-coated tablet Oral use Republic U kabelovny 130 phenylephrine mg 5 mg 102 37 Praha 10 hydrochloride Dolní Měcholupy Czech Republic Czech Zentiva, k.s. Ibuprofen lysine Ibalgin Rapid 683,25 mg Film-coated tablet Oral use Republic U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Czech Vitabalans Oy Ibuprofen Ibumax 200 mg 200 mg Film-coated tablet Oral use Republic Varastokatu 8 13500 Hämeenlinna Finland Czech Vitabalans Oy Ibuprofen Ibumax 400 mg 400 mg Film-coated tablet Oral use Republic Varastokatu 8 13500 Hämeenlinna Finland

41

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Czech Vitabalans Oy Ibuprofen Ibumax 600 mg 600 mg Film-coated tablet Oral use Republic Varastokatu 8 13500 Hämeenlinna Finland Czech Generics UK Ibuprofen lysine Ibumyl Rapid 400 mg 684 mg Film-coated tablet Oral use Republic Albany Gate Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom Czech MEDREG s.r.o. Ibuprofen Ibunex 200 mg 200 mg Film-coated tablet Oral use Republic Krčmářovská 223/33 potahované tablety 196 00 Praha 9 Czech Republic Czech MEDREG s.r.o. Ibuprofen Ibunex 400 mg 400 mg Film-coated tablet Oral use Republic Krčmářovská 223/33 potahované tablety 196 00 Praha 9 Czech Republic Czech GALMED a.s. Ibuprofen Ibuprofen 400 mg 400 mg Film-coated tablet Oral use Republic Těšínská 1349/296 Galmed 716 00 Ostrava - Radvanice Czech Republic Czech ALIUD PHARMA GmbH Ibuprofen Ibuprofen AL 400 400 mg Film-coated tablet Oral use Republic Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

42

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Czech Dr. Max Pharma Ltd. Ibuprofen Ibuprofen Dr. MAX 200 200 mg Film-coated tablet Oral use Republic First Floor Roxburge House, MG potahované tablety Regent Street 273-287 W1B 2HA London United Kingdom Czech Dr. Max Pharma Ltd. Ibuprofen Ibuprofen Dr. MAX 400 400 mg Film-coated tablet Oral use Republic First Floor Roxburge House, mg potahované tablety Regent Street 273-287 W1B 2HA London United Kingdom Czech Galpharm Healthcare Ibuprofen Ibuprofen Galpharm 200 mg Film-coated tablet Oral use Republic Limited 200 mg potahované Hugh House tablety Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom Czech Galpharm Healthcare Ibuprofen Ibuprofen Galpharm 400 mg Film-coated tablet Oral use Republic Limited 400 mg potahované Hugh House tablety Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

43

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Czech Wrafton Laboratories Ibuprofen lysine Ibuprofen Perrigo 200 342 mg Film-coated tablet Oral use Republic Limited mg potahované tablety Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom Czech Wrafton Laboratories Ibuprofen lysine Ibuprofen Perrigo 400 684 mg Film-coated tablet Oral use Republic Limited mg Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom Czech Abbott Laboratories, s.r.o. Ibuprofen Brufedol 200 mg 200 mg Effervescent granules Oral use Republic Evropská 2591/33d šumivé granule 160 00 Praha 6 - Hadovka Office Park Czech Republic Czech Zentiva, k.s. Ibuprofen Modafen 200 mg Film-coated tablet Oral use Republic U kabelovny 130 pseudoephedrine 30 mg 102 37 Praha 10 hydrochloride Dolní Měcholupy Czech Republic

44

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Czech Reckitt Benckiser Healthcare Ibuprofen Nurofen 200 mg 200 mg Coated tablet Oral use Republic International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Czech Reckitt Benckiser Healthcare Ibuprofen Nurofen 400 mg 400 mg Coated tablet Oral use Republic International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Czech Reckitt Benckiser Healthcare Ibuprofen lysine Nurofen Instant 400 mg 683,34 mg Powder for oral Oral use Republic International Limited rozpustný prášek solution Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Czech Reckitt Benckiser Healthcare Ibuprofen sodium Nurofen Neo 200 mg 256 mg Coated tablet Oral use Republic International Limited dihydrate obalené tablety Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

45

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Czech Reckitt Benckiser Healthcare Ibuprofen sodium Nurofen Neo Femina 512 mg Coated tablet Oral use Republic International Limited dihydrate 400 mg obalené tablety Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Czech Reckitt Benckiser Healthcare Ibuprofen Nurofen Rapid 200 mg 200 mg Capsule, soft Oral use Republic International Limited capsules Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Czech Reckitt Benckiser Healthcare Ibuprofen Nurofen Rapid 400 mg 400 mg Capsule, soft Oral use Republic International Limited capsules Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Czech Reckitt Benckiser Healthcare Ibuprofen Nurofen Stopgrip 200 mg Film-coated tablet Oral use Republic International Limited pseudoephedrine 30 mg Bath Road 103-105 hydrochloride Berkshire SL1 3UH Slough United Kingdom

46

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Denmark Abbott Scandinavia AB Ibuprofen Brufen 400 mg Film-coated tablet Oral use Hemvärnsgatan 9 (Box 1498, 171 29 Solna) SE-171 54 Solna Sweden Denmark Takeda Pharma A/S Ibuprofen Ibumetin 200 mg Film-coated tablet Oral use Dybendal Alle 10 DK-2630 Taastrup Denmark Denmark Takeda Pharma A/S Ibuprofen Ibumetin 400 mg Film-coated tablet Oral use Dybendal Alle 10 DK-2630 Taastrup Denmark Denmark Takeda Pharma A/S Ibuprofen Ibumetin 600 mg Film-coated tablet Oral use Dybendal Alle 10 DK-2630 Taastrup Denmark Denmark Actavis Nordic A/S Ibuprofen Ibuprofen "Actavis" 400 mg Film-coated tablet Oral use Ørnegårdsvej 16 DK-2820 Gentofte Denmark Denmark Abbott Scandinavia AB Ibuprofen Brufen 600 mg Film-coated tablet Oral use Hemvärnsgatan 9 (Box 1498, 171 29 Solna) SE-171 54 Solna Sweden

47

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Denmark Abbott Scandinavia AB Ibuprofen Brufen Retard 800 mg Prolonged-release Oral use Hemvärnsgatan 9 tablet (Box 1498, 171 29 Solna) SE-171 54 Solna Sweden Denmark Infirst Healthcare Ltd. Ibuprofen Flarin 200 mg Capsule, soft Oral use Strand 265 London WC2R 1BH United Kingdom Denmark Infirst Healthcare Ltd. Ibuprofen Flarin 400 mg Capsule, soft Oral use Strand 265 London WC2R 1BH United Kingdom Denmark Vitabalans Oy Ibuprofen Ibumax 400 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Denmark Vitabalans Oy Ibuprofen Ibumax 600 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Denmark Vitabalans Oy Ibuprofen Ibumax 200 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland

48

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Denmark Takeda Pharma A/S Ibuprofen Ibumetin Retard 600 mg Prolonged-release Oral use Dybendal Alle 10 tablet DK-2630 Taastrup Denmark Denmark Alchemia Ltd., Ibuprofen Ibunin 200 mg Film-coated tablet Oral use Jermyn Street 86 5th floor SW1 Y6AW London United Kingdom Denmark Alchemia Ltd., Ibuprofen Ibunin 400 mg Film-coated tablet Oral use Jermyn Street 86 5th floor SW1 Y6AW London United Kingdom Denmark Alternova A/S Ibuprofen Ibupama 200 mg Film-coated tablet Oral use Lodshusvej 11 DK-4230 Skælskør Denmark Denmark Alternova A/S Ibuprofen Ibupama 400 mg Film-coated tablet Oral use Lodshusvej 11 DK-4230 Skælskør Denmark Denmark Alternova A/S Ibuprofen Ibupama 600 mg Film-coated tablet Oral use Lodshusvej 11 DK-4230 Skælskør Denmark

49

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Denmark Actavis Nordic A/S Ibuprofen Ibuprofen "Actavis" 600 mg Film-coated tablet Oral use Ørnegårdsvej 16 DK-2820 Gentofte Denmark Denmark Alternova A/S Ibuprofen Ibuprofen "Alternova" 400 mg Film-coated tablet Oral use Lodshusvej 11 DK-4230 Skælskør Denmark Denmark Alternova A/S Ibuprofen Ibuprofen "Alternova" 600 mg Film-coated tablet Oral use Lodshusvej 11 DK-4230 Skælskør Denmark Denmark Alternova A/S Ibuprofen Ibuprofen "Alternova" 200 mg Film-coated tablet Oral use Lodshusvej 11 DK-4230 Skælskør Denmark Denmark Farmalider S.A. Ibuprofen Ibuprofen "Farmalider" 20 mg/ml Oral suspension Oral use C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain Denmark Farmalider S.A. Ibuprofen Ibuprofen "Farmalider" 40 mg/ml Oral suspension Oral use C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

50

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Denmark Orifarm Generics A/S Ibuprofen Ibuprofen "Orifarm" 200 mg Film-coated tablet Oral use Energivej 15 POB 69 DK-5260 Odense S Denmark Denmark Orifarm Generics A/S Ibuprofen Ibuprofen "Orifarm" 400 mg Film-coated tablet Oral use Energivej 15 POB 69 DK-5260 Odense S Denmark Denmark Orifarm Generics A/S Ibuprofen Ibuprofen "Orifarm" 600 mg Film-coated tablet Oral use Energivej 15 POB 69 DK-5260 Odense S Denmark Denmark Teva Denmark A/S Ibuprofen Ibuprofen "Teva" 200 mg Film-coated tablet Oral use Parallelvej 10-12, DK-2800 Kongens Lyndby Denmark Denmark Teva Denmark A/S Ibuprofen Ibuprofen "Teva" 400 mg Film-coated tablet Oral use Parallelvej 10-12 DK-2800 Kongens Lyndby Denmark Denmark Berlin-Chemie AG Ibuprofen Ibustar 400 mg Film-coated tablet Oral use Glienicker Weg 125 12489 Berlin Germany

51

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Denmark Actavis Group PTC ehf Ibuprofen Ifenin 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Denmark Actavis Group PTC ehf Ibuprofen Ifenin 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Denmark Actavis Group PTC ehf Ibuprofen Ifenin 600 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Denmark Actavis Group PTC ehf Ibuprofen Ifenin 800 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Denmark Takeda Pharma A/S Ibuprofen Ipren 200 mg Film-coated tablet Oral use Dybendal Alle 10 DK-2630 Taastrup Denmark Denmark Nordic Drugs AB Dexibuprofen Seractiv 300 mg Film-coated tablet Oral use Geijersgatan 2A Box 30035 200 61 Limhamn Sweden

52

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Denmark Nordic Drugs AB Dexibuprofen Seractiv 400 mg Film-coated tablet Oral use Geijersgatan 2A Box 30035 200 61 Limhamn Sweden Estonia AS Grindeks Ibuprofen IBUFLUX 400 MG 400 mg Film-coated tablet Oral use Krustpils 53 LV-1057 Riga Latvia Estonia Vitabalans Oy Ibuprofen IBUMAX 400 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Estonia Reckitt Benckiser (Poland) Ibuprofen NUROFEN 200 mg Coated tablet Oral use S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Estonia STADA Arzneimittel AG Ibuprofen IBUDOLOR 200 mg Film-coated tablet Oral use Stadastr. 2-18 61118 Bad Vilbel Germany Estonia Lannacher Heilmittel GmbH Ibuprofen IBUPROFEN 400 mg Film-coated tablet Oral use Schlossplatz 1 LANNACHER A-8502 Lannach Austria

53

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Estonia Lannacher Heilmittel GmbH Ibuprofen IBUPROFEN 600 mg Film-coated tablet Oral use Schlossplatz 1 LANNACHER A-8502 Lannach Austria Estonia AS Grindeks Ibuprofen IBUPROFEN-GRINDEKS 200 mg Film-coated tablet Oral use Krustpils 53 LV-1057 Riga Latvia Estonia Takeda Pharma AS Ibuprofen IBUMETIN 200 mg Film-coated tablet Oral use Jaama 55B Polva 63308 Estonia Estonia Takeda Pharma AS Ibuprofen IBUMETIN 400 mg Film-coated tablet Oral use Jaama 55B Polva 63308 Estonia Estonia Takeda Pharma AS Ibuprofen IBUMETIN 600 mg Film-coated tablet Oral use Jaama 55B Polva 63308 Estonia Estonia Vitabalans Oy Ibuprofen IBUMAX 600 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland

54

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Estonia Reckitt Benckiser (Poland) Ibuprofen NUROFEN FORTE 400 mg Coated tablet Oral use S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Estonia Vitabalans Oy Ibuprofen IBUMAX 200 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Estonia Reckitt Benckiser (Poland) Ibuprofen NUROFEN EXPRESS 200 mg Coated tablet Oral use S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Estonia Reckitt Benckiser (Poland) Ibuprofen NUROFEN FORTE 400 mg Coated tablet Oral use S.A. EXPRESS ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Estonia Berlin-Chemie AG Ibuprofen IBUSTAR 400 mg Film-coated tablet Oral use Glienicker Weg 125 12489 Berlin Germany

55

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Estonia Actavis Group PTC ehf Ibuprofen IBUPROFEN ACTAVIS 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Estonia Actavis Group PTC ehf Ibuprofen IBUPROFEN ACTAVIS 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Estonia Actavis Group PTC ehf Ibuprofen IBUPROFEN ACTAVIS 600 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Estonia Actavis Group PTC ehf Ibuprofen IBUPROFEN ACTAVIS 800 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Estonia Actavis Group PTC ehf Ibuprofen IFENIN 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Estonia Actavis Group PTC ehf Ibuprofen IFENIN 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Estonia ratiopharm GmbH Ibuprofen IBUPROFEN- 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 RATIOPHARM 400 MG 89079 Ulm Germany

56

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Estonia BGP Products SIA Ibuprofen BRUFEN 200 mg Film-coated tablet Oral use Mūkusalas 101 Riga, LV 1004 Latvia Estonia BGP Products SIA Ibuprofen BRUFEN 400 mg Film-coated tablet Oral use Mūkusalas 101 Riga, LV 1004 Latvia Estonia ratiopharm GmbH Ibuprofen BUTIFEN 400 MG 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Estonia BGP Products SIA Ibuprofen BRUFEN 20 mg/ml Oral suspension Oral use Mūkusalas 101 Riga, LV 1004 Latvia Estonia BGP Products SIA Ibuprofen BRUFEN 800 mg Prolonged-release Oral use Mūkusalas 101 tablet Riga, LV 1004 Latvia Estonia BGP Products SIA Ibuprofen BRUFEN 200 mg Effervescent granules Oral use Mūkusalas 101 Riga, LV 1004 Latvia Estonia BGP Products SIA Ibuprofen BRUFEN 400 mg Effervescent granules Oral use Mūkusalas 101 Riga, LV 1004 Latvia

57

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Estonia BGP Products SIA Ibuprofen BRUFEN 600 mg Effervescent granules Oral use Mūkusalas 101 Riga, LV 1004 Latvia Estonia BGP Products SIA Ibuprofen BRUFEN PLUS 400 mg Film-coated tablet Oral use Mūkusalas 101 codeine 30 mg Riga, LV 1004 Latvia Estonia BGP Products SIA Ibuprofen BRUFEN 40 mg/ml Oral suspension Oral use Mūkusalas 101 Riga, LV 1004 Latvia Finland Orion Pharma Ibuprofen BURANA 200 mg Film-coated tablet Oral use Orionintie 1 PL 65 02101 ESPOO Finland Finland Orion Pharma Ibuprofen BURANA 400 mg Film-coated tablet Oral use Orionintie 1 PL 65 02101 ESPOO Finland Finland Orion Pharma Ibuprofen BURANA 600 mg Film-coated tablet Oral use Orionintie 1 PL 65 02101 ESPOO Finland

58

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Finland Orion Pharma Ibuprofen BURANA 800 mg Film-coated tablet Oral use Orionintie 1 PL 65 02101 ESPOO Finland Finland Orion Pharma Ibuprofen BURANA 20 mg/ml Oral suspension Oral use Orionintie 1 PL 65 02101 ESPOO Finland Finland Orion Pharma Ibuprofen BURANA 40 mg/ml Oral suspension Oral use Orionintie 1 PL 65 02101 ESPOO Finland Finland Orion Pharma Ibuprofen BURANA SLOW 800 mg Prolonged-release Oral use Orionintie 1 tablet PL 65 02101 ESPOO Finland Finland Orion Pharma Ibuprofen BURANA-CAPS 400 mg Capsule, soft Oral use Orionintie 1 PL 65 02101 ESPOO Finland

59

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Finland Orion Pharma Ibuprofen BURANA-PORE 200 mg Effervescent tablet Oral use Orionintie 1 PL 65 02101 ESPOO Finland Finland Orion Pharma Ibuprofen BURANA-PORE 400 mg Effervescent tablet Oral use Orionintie 1 PL 65 02101 ESPOO Finland Finland Vitabalans Oy Ibuprofen IBUMAX 200 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Finland Vitabalans Oy Ibuprofen IBUMAX 400 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Finland Vitabalans Oy Ibuprofen IBUMAX 600 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Finland Vitabalans Oy Ibuprofen IBUMAX 800 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland

60

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Finland Oy Leiras Takeda Ibuprofen IBUMETIN 400 mg Film-coated tablet Oral use Paciuksenkatu 21 PL 1406 00101 HELSINKI Finland Finland Oy Leiras Takeda Ibuprofen IBUMETIN 600 mg Film-coated tablet Oral use Paciuksenkatu 21 PL 1406 00101 HELSINKI Finland Finland Laboratorios Farmalider S.A. Ibuprofen IBUPROFEN 20 mg/ml Oral suspension Oral use Aragoneses, 15. Polígono FARMALIDER Industrial de Alcobendas 28108 ALCOBENDAS Spain Finland Laboratorios Farmalider S.A. Ibuprofen IBUPROFEN 40 mg/ml Oral suspension Oral use Aragoneses, 15. Polígono FARMALIDER Industrial de Alcobendas 28108 ALCOBENDAS Spain Finland Galpharm Healthcare Ibuprofen IBUPROFEN GALPHARM 200 mg Film-coated tablet Oral use Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

61

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Finland Galpharm Healthcare Ibuprofen IBUPROFEN GALPHARM 400 mg Film-coated tablet Oral use Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom Finland Orion Pharma Ibuprofen IBUSAL 200 mg Film-coated tablet Oral use Orionintie 1 PL 65 02101 ESPOO Finland Finland Orion Pharma Ibuprofen IBUSAL 400 mg Film-coated tablet Oral use Orionintie 1 PL 65 02101 ESPOO Finland Finland Orion Pharma Ibuprofen IBUSAL 600 mg Film-coated tablet Oral use Orionintie 1 PL 65 02101 ESPOO Finland Finland Orion Pharma Ibuprofen IBUSAL 800 mg Film-coated tablet Oral use Orionintie 1 PL 65 02101 ESPOO Finland

62

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Finland Orion Pharma Ibuprofen IBUTABS 400 mg Film-coated tablet Oral use Orionintie 1 PL 65 02101 ESPOO Finland Finland ratiopharm GmbH Ibuprofen IBUXIN 200 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Finland ratiopharm GmbH Ibuprofen IBUXIN 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Finland ratiopharm GmbH Ibuprofen IBUXIN 600 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Finland ratiopharm GmbH Ibuprofen IBUXIN 800 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Finland ratiopharm GmbH Ibuprofen IBUXIN RAPID 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany

63

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Finland Berlin-Chemie AG Ibuprofen MIG-400 400 mg Film-coated tablet Oral use Glienicker Weg 125 12489 Berlin Germany Finland Reckitt Benckiser Healthcare Ibuprofen NUROFEN APPELSIINI 40 mg/ml Oral suspension Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Finland Reckitt Benckiser Healthcare Ibuprofen NUROFEN MANSIKKA 40 mg/ml Oral suspension Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Finland Orion Pharma Ibuprofen BURANA-C 400 mg Film-coated tablet Oral use Orionintie 1 ascorbic acid 300 mg PL 65 02101 ESPOO Finland Finland Abbott Scandinavia AB Ibuprofen ARDINEX 200 mg Film-coated tablet Oral use P.O Box 1498 codeine 30 mg SE-171 29 Solna Sweden

64

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Finland Orion Pharma Ibuprofen BURANA COMP 200 mg Film-coated tablet Oral use Orionintie 1 codeine 30 mg PL 65 02101 ESPOO Finland Finland Orion Pharma Ibuprofen BURANA COMP 400 mg Film-coated tablet Oral use Orionintie 1 codeine 60 mg PL 65 02101 ESPOO Finland Finland Abbott Oy Ibuprofen ARDINEX 400 mg Film-coated tablet Oral use Pihatörmä 1 B codeine 30 mg 02240 ESPOO Finland France PFIZER SANTE FAMILIALE Ibuprofen ADVIL 200 mg, 200 mg Coated tablet Oral use 23-25, avenue du Docteur comprimé enrobé Lannelongue 75014 Paris France France PFIZER SANTE FAMILIALE Ibuprofen ADVIL 400 mg, 400 mg Effervescent tablet Oral use 23-25, avenue du Docteur comprimé effervescent Lannelongue 75014 Paris France

65

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France PFIZER SANTE FAMILIALE Ibuprofen ADVIL 400 mg, 400 mg Coated tablet Oral use 23-25, avenue du Docteur comprimé enrobé Lannelongue 75014 Paris France France PFIZER SANTE FAMILIALE Ibuprofen ADVILCAPS 200 mg, 200 mg Capsule, soft Oral use 23-25, avenue du Docteur capsule molle Lannelongue 75014 Paris France France PFIZER SANTE FAMILIALE Ibuprofen ADVILCAPS 400 mg, 400 mg Capsule, soft Oral use 23-25, avenue du Docteur capsule molle Lannelongue 75014 Paris France France PFIZER SANTE FAMILIALE Ibuprofen ADVILEFF 200 mg, 200 mg Effervescent tablet Oral use 23-25, avenue du Docteur comprimé effervescent Lannelongue 75014 Paris France France PFIZER SANTE FAMILIALE Ibuprofen ADVILMED 400 mg, 400 mg Coated tablet Oral use 23-25, avenue du Docteur comprimé enrobé Lannelongue 75014 Paris France

66

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France PFIZER SANTE FAMILIALE Ibuprofen ADVILTAB 200 mg, 200 mg Coated tablet Oral use 23-25, avenue du Docteur comprimé enrobé Lannelongue 75014 Paris France France JOLLY JATEL Ibuprofen ALGIFENE 200 mg, 200 mg Tablet Oral use 28, avenue Carnot comprimé enrobé 78951 Saint Germain en Laye Cedex France France ELERTE Ibuprofen ANTARENE 200 mg, 200 mg Tablet Oral use 181 - 183, rue André comprimé pelliculé Karman BP 101 93303 Aubervilliers Cedex France France ELERTE Ibuprofen ANTARENE 400 mg, 400 mg Tablet Oral use 181 - 183, rue André comprimé pelliculé Karman BP 101 93303 Aubervilliers Cedex France France ELERTE Ibuprofen ANTARENE CODEINE 200 mg Tablet Oral use 181 - 183, rue André codeine 200 mg/30 mg, 30 mg Karman comprimé pelliculé BP 101 93303 Aubervilliers Cedex France

67

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France ELERTE Ibuprofen ANTARENE CODEINE 400 mg Tablet Oral use 181 - 183, rue André codeine 400 mg/60 mg, 60 mg Karman comprimé pelliculé BP 101 93303 Aubervilliers Cedex France France Abbott France Ibuprofen BRUFEN 400 mg, 400 mg Tablet Oral use 3 place Gustave Eiffel comprimé pelliculé Bâtiment Florence 94518 Rungis Cedex France France CRISTERS Ibuprofen CRIFENE 400 mg, 400 mg Tablet Oral use 22 quai Gallieni comprimé pelliculé 92150 Suresnes France France MERCK MEDICATION Ibuprofen ERGIX 200 mg 200 mg Tablet Oral use FAMILIALE DOULEUR ET FIEVRE, 37, rue Saint-Romain comprimé pelliculé 69379 Lyon Cedex 08 France France AJC INVEST Ibuprofen EXPANFEN 200 mg, 200 mg Tablet Oral use Rue de la Rochefoucauld 6 comprimé enrobé 16000 Angoulême France France COOPER Ibuprofen GELUFENE 200 mg, 200 mg Capsule, hard Oral use Place Lucien-Auvert gélule 77020 Melun Cedex France

68

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France ELERTE Ibuprofen HEMAGENE TAILLEUR 200 mg Tablet Oral use 181 - 183, rue André 200 mg, comprimé Karman pelliculé BP 101 93303 Aubervilliers Cedex France France Banner Pharmacaps Europe Ibuprofen IBUCAPS 200 mg, 200 mg Capsule, soft Oral use B.V. capsule molle De Posthoornstraat 7 5048 AS Tilburg The Netherlands France Pharmachemie B.V. Ibuprofen IBUFEN 200 mg, 200 mg Tablet Oral use Swensweg 5 - Haarlem comprimé enrobé PO Box 552 2003 RN Haarlem The Netherlands France Pharmachemie B.V. Ibuprofen IBUFEN 400 mg, 400 mg Tablet Oral use Swensweg 5 - Haarlem comprimé enrobé PO Box 552 2003 RN Haarlem The Netherlands France Actavis Group PTC ehf Ibuprofen IBUPROFENE ACTAVIS 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 400 mg, comprimé 220 Hafnarfjörður pelliculé Iceland

69

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France Biogaran Ibuprofen IBUPROFENE ALMUS 200 mg Film-coated tablet Oral use Boulevard Charles de Gaulle 200 mg, comprimé 15 pelliculé 92700 Colombes France France Biogaran Ibuprofen IBUPROFENE ALMUS 400 mg Film-coated tablet Oral use Boulevard Charles de Gaulle 400 mg, comprimé 15 pelliculé 92700 Colombes France France ARROW GENERIQUES Ibuprofen IBUPROFENE ARROW 200 mg Coated tablet Oral use 26, avenue Tony Garnier 200 mg, comprimé 69007 Lyon enrobé France France ARROW GENERIQUES Ibuprofen IBUPROFENE ARROW 400 mg Film-coated tablet Oral use 26, avenue Tony Garnier 400 mg, comprimé 69007 Lyon pelliculé France France ARROW GENERIQUES Ibuprofen IBUPROFENE ARROW 400 mg Film-coated tablet Oral use 26, avenue Tony Garnier CONSEIL 400 mg, 69007 Lyon comprimé pelliculé France France INTERNATIONAL DRUG Ibuprofen IBUPROFENE BIO 400 mg Effervescent tablet Oral use DEVELOPMENT VALYS 400 mg, 5, rue Simonet comprimé effervescent 75013 Paris France

70

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France Biogaran Ibuprofen IBUPROFENE 200 mg Film-coated tablet Oral use Boulevard Charles de Gaulle BIOGARAN 200 mg, 15 comprimé pelliculé 92700 Colombes France France Biogaran Ibuprofen IBUPROFENE 400 mg Film-coated tablet Oral use Boulevard Charles de Gaulle BIOGARAN 400 mg, 15 comprimé pelliculé 92700 Colombes France France Biogaran Ibuprofen IBUPROFENE 200 mg Film-coated tablet Oral use Boulevard Charles de Gaulle BIOGARAN CONSEIL 15 200 mg, comprimé 92700 Colombes pelliculé France France Biogaran Ibuprofen IBUPROFENE 400 mg Film-coated tablet Oral use Boulevard Charles de Gaulle BIOGARAN CONSEIL 15 400 mg, comprimé 92700 Colombes pelliculé France France CRISTERS Ibuprofen IBUPROFENE CRISTERS 200 mg Coated tablet Oral use 22 quai Gallieni 200 mg, comprimé 92150 Suresnes enrobé France France CRISTERS Ibuprofen IBUPROFENE CRISTERS 200 mg Film-coated tablet Oral use 22 quai Gallieni 200 mg, comprimé 92150 Suresnes pelliculé France

71

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France CRISTERS Ibuprofen IBUPROFENE CRISTERS 400 mg Film-coated tablet Oral use 22 quai Gallieni 400 mg, comprimé 92150 Suresnes pelliculé France France EG LABO - LABORATOIRES Ibuprofen IBUPROFENE EG 200 200 mg Film-coated tablet Oral use EUROGENERICS mg, comprimé pelliculé "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France France EG LABO - LABORATOIRES Ibuprofen IBUPROFENE EG 400 400 mg Film-coated tablet Oral use EUROGENERICS mg, comprimé pelliculé "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France France ELAIAPHARM Ibuprofen IBUPROFENE 200 mg Film-coated tablet Oral use 2881, Route des Crêtes ELAIAPHARM 200 mg, BP 205 Valbonne comprimé pelliculé 06904 Sophia Antipolis Cedex France

72

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France ETHYPHARM Ibuprofen IBUPROFENE 300 mg Prolonged-release Oral use 194, Bureaux de la Colline ETHYPHARM L.P.300 capsule, hard Bâtiment D mg, microgranules à 92213 Saint-Cloud Cedex libération prolongée en France gélule France EVOLUPHARM Ibuprofen IBUPROFENE 400 mg Film-coated tablet Oral use rue Irène Caron EVOLUGEN 400 mg, Zone Industrielle d'Auneuil comprimé pelliculé 60390 Auneuil France France Farmalider S.A. Ibuprofen IBUPROFENE 400 mg Film-coated tablet Oral use C/ Aragoneses, 15 FARMALIDER 400 mg, Alcobendas (Madrid), 28108 comprimé pelliculé Spain France GIBAUD PHARMA Ibuprofen IBUPROFENE GIBAUD 200 mg Coated tablet Oral use 73, rue de la Tour 200 mg, comprimé 42002 Saint-Etienne Cedex enrobé 1 France France PLUS PHARMACIE Ibuprofen IBUPROFENE ISOMED 200 mg Coated tablet Oral use 26, boulevard Paul Vaillant- 200 mg, comprimé Couturier enrobé 94200 Ivry-sur-Seine France France MYLAN SAS Ibuprofen IBUPROFENE MYLAN 200 mg Coated tablet Oral use 117, allée des Parcs 200 mg, comprimé 69800 Saint-Priest enrobé France

73

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France MYLAN SAS Ibuprofen IBUPROFENE MYLAN 400 mg Effervescent tablet Oral use 117, allée des Parcs 400 mg, comprimé 69800 Saint-Priest effervescent France France MYLAN SAS Ibuprofen IBUPROFENE MYLAN 400 mg Film-coated tablet Oral use 117, allée des Parcs 400 mg, comprimé 69800 Saint-Priest pelliculé France France MYLAN SAS Ibuprofen IBUPROFENE MYLAN 200 mg Film-coated tablet Oral use 117, allée des Parcs CONSEIL 200 mg, 69800 Saint-Priest comprimé pelliculé France France MYLAN SAS Ibuprofen IBUPROFENE MYLAN 400 mg Film-coated tablet Oral use 117, allée des Parcs CONSEIL 400 mg, 69800 Saint-Priest comprimé pelliculé France France LABORATOIRES NEPENTHES Ibuprofen IBUPROFENE 200 mg Film-coated tablet Oral use 13, avenue Paul Langevin NEPENTHES 200 mg, ZA de la patte d'oie comprimé pelliculé 95220 Herblay France France LABORATOIRES NEPENTHES Ibuprofen IBUPROFENE 400 mg Film-coated tablet Oral use 13, avenue Paul Langevin NEPENTHES 400 mg, ZA de la patte d'oie comprimé pelliculé 95220 Herblay France

74

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France Biogaran Ibuprofen IBUPROFENE NOR 400 400 mg Film-coated tablet Oral use Boulevard Charles de Gaulle mg, comprimé pelliculé 15 92700 Colombes France France Biogaran Ibuprofen IBUPROFENE PHR LAB 400 mg Film-coated tablet Oral use Boulevard Charles de Gaulle 400 mg, comprimé 15 pelliculé 92700 Colombes France France RANBAXY PHARMACIE Ibuprofen IBUPROFENE RANBAXY 200 mg Film-coated tablet Oral use GENERIQUES MEDICATION 11-15 Quai Dion Bouton OFFICINALE 200 mg, 92800 Puteaux comprimé pelliculé France France RANBAXY PHARMACIE Ibuprofen IBUPROFENE RANBAXY 400 mg Film-coated tablet Oral use GENERIQUES MEDICATION 11-15 Quai Dion Bouton OFFICINALE 400 mg, 92800 Puteaux comprimé pelliculé France France ratiopharm GmbH Ibuprofen IBUPROFENE 200 mg Coated tablet Oral use Graf-Arco-Str. 3 RATIOPHARM 200 mg, 89079 Ulm comprimé enrobé Germany

75

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France TEVA SANTE Ibuprofen IBUPROFENE 400 mg Film-coated tablet Oral use Esplanade du Général de RATIOPHARM 400 mg, Gaulle 110 comprimé pelliculé 92931 Paris La Défense Cedex France France TEVA SANTE Ibuprofen IBUPROFENE 200 mg Coated tablet Oral use Esplanade du Général de RATIOPHARM CONSEIL Gaulle 110 200 mg, comprimé 92931 Paris La Défense enrobé Cedex France France TEVA SANTE Ibuprofen IBUPROFENE 400 mg Film-coated tablet Oral use Esplanade du Général de RATIOPHARM CONSEIL Gaulle 110 400 mg, comprimé 92931 Paris La Défense pelliculé Cedex France France Biogaran Ibuprofen IBUPROFENE REF 200 200 mg Coated tablet Oral use Boulevard Charles de Gaulle mg, comprimé pelliculé 15 92700 Colombes France France RANBAXY PHARMACIE Ibuprofen IBUPROFENE RPG 400 400 mg Film-coated tablet Oral use GENERIQUES mg, comprimé pelliculé 11-15 Quai Dion Bouton 92800 Puteaux France

76

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France SANDOZ Ibuprofen IBUPROFENE SANDOZ 200 mg Coated tablet Oral use 49, avenue Georges 200 mg, comprimé Pompidou enrobé 92300 Levallois-Perret France France SANDOZ Ibuprofen IBUPROFENE SANDOZ 200 mg Film-coated tablet Oral use 49, avenue Georges 200 mg, comprimé Pompidou pelliculé 92300 Levallois-Perret France France SANDOZ Ibuprofen IBUPROFENE SANDOZ 400 mg Coated tablet Oral use 49, avenue Georges 400 mg, comprimé Pompidou enrobé 92300 Levallois-Perret France France SANDOZ Ibuprofen IBUPROFENE SANDOZ 400 mg Film-coated tablet Oral use 49, avenue Georges 400 mg, comprimé Pompidou pelliculé 92300 Levallois-Perret France France SANDOZ Ibuprofen IBUPROFENE SANDOZ 200 mg Coated tablet Oral use 49, avenue Georges CONSEIL 200 mg, Pompidou comprimé enrobé 92300 Levallois-Perret France

77

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France SANDOZ Ibuprofen IBUPROFENE SANDOZ 400 mg Film-coated tablet Oral use 49, avenue Georges CONSEIL 400 mg, Pompidou comprimé pelliculé 92300 Levallois-Perret France France TEVA SANTE Ibuprofen IBUPROFENE TEVA 200 200 mg Coated tablet Oral use Esplanade du Général de mg, comprimé enrobé Gaulle 110 92931 Paris La Défense Cedex France France TEVA SANTE Ibuprofen IBUPROFENE TEVA 400 400 mg Film-coated tablet Oral use Esplanade du Général de mg, comprimé pelliculé Gaulle 110 92931 Paris La Défense Cedex France France TEVA SANTE Ibuprofen IBUPROFENE TEVA 200 mg Coated tablet Oral use Esplanade du Général de CONSEIL 200 mg, Gaulle 110 comprimé enrobé 92931 Paris La Défense Cedex France France PFIZER HOLDING FRANCE Ibuprofen IBUPROFENE UNION 200 mg Film-coated tablet Oral use 23-25, avenue du Docteur INTERPHARMACEUTIQU Lannelongue E ATLANTIQUE 200 mg, 75014 Paris comprimé pelliculé France

78

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France PFIZER HOLDING FRANCE Ibuprofen IBUPROFENE UNION 400 mg Film-coated tablet Oral use 23-25, avenue du Docteur INTERPHARMACEUTIQU Lannelongue E ATLANTIQUE 400 mg, 75014 Paris comprimé pelliculé France France PFIZER HOLDING FRANCE Ibuprofen IBUPROFENE UPJOHN 200 mg Film-coated tablet Oral use 23-25, avenue du Docteur 200 mg, comprimé Lannelongue pelliculé 75014 Paris France France PFIZER SANTE FAMILIALE Ibuprofen IBUPROFENE WYETH 400 mg Effervescent tablet Oral use 23-25, avenue du Docteur SANTE FAMILIALE 400 Lannelongue mg, comprimé 75014 Paris effervescent France France ZYDUS FRANCE Ibuprofen IBUPROFENE ZF 400 400 mg Film-coated tablet Oral use 25, rue des Peupliers mg, comprimé pelliculé ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers 92000 Nanterre France

79

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France ZYDUS FRANCE Ibuprofen IBUPROFENE ZYDUS 200 mg Coated tablet Oral use 25, rue des Peupliers 200 mg, comprimé ZAC Les Hautes Pâtures - enrobé Parc d’Activités des Peupliers 92000 Nanterre France France ZYDUS FRANCE Ibuprofen IBUPROFENE ZYDUS 400 mg Film-coated tablet Oral use 25, rue des Peupliers 400 mg, comprimé ZAC Les Hautes Pâtures - pelliculé Parc d’Activités des Peupliers 92000 Nanterre France France ZYDUS FRANCE Ibuprofen IBUPROFENE ZYDUS 200 mg Film-coated tablet Oral use 25, rue des Peupliers FRANCE 200 mg, ZAC Les Hautes Pâtures - comprimé pelliculé Parc d’Activités des Peupliers 92000 Nanterre France France ZYDUS FRANCE Ibuprofen IBUPROFENE ZYDUS 400 mg Film-coated tablet Oral use 25, rue des Peupliers FRANCE 400 mg, ZAC Les Hautes Pâtures - comprimé pelliculé Parc d’Activités des Peupliers 92000 Nanterre France

80

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France Actavis Group PTC ehf Ibuprofen IBUTABS 200 mg, 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 comprimé pelliculé 220 Hafnarfjörður Iceland France Actavis Group PTC ehf Ibuprofen IBUTABS 400 mg, 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 comprimé pelliculé 220 Hafnarfjörður Iceland France URGO Ibuprofen INTRALGIS 200 mg, 200 mg Film-coated tablet Oral use 42, rue de Longvic comprimé pelliculé BP 157 21304 Chenôve Cedex France France RECKITT BENCKISER Ibuprofen NUREFLEX 200 mg, 200 mg Coated tablet Oral use HEALTHCARE FRANCE comprimé enrobé 15, rue Ampère 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen NUREFLEX 400 mg, 400 mg Coated tablet Oral use HEALTHCARE FRANCE comprimé enrobé 15, rue Ampère 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen NUREFLEX 400 mg, 400 mg Effervescent granules Oral use HEALTHCARE FRANCE granulés effervescents 15, rue Ampère en sachet-dose 91748 Massy Cedex France

81

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France RECKITT BENCKISER Ibuprofen NUREFLEX L.P. 300 mg, 300 mg Prolonged-release Oral use HEALTHCARE FRANCE gélule à libération capsule, hard 15, rue Ampère prolongée 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen NUROFEN 200 mg, 200 mg Capsule, soft Oral use HEALTHCARE FRANCE capsule molle 15, rue Ampère 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen NUROFEN 200 mg, 200 mg Coated tablet Oral use HEALTHCARE FRANCE comprimé enrobé 15, rue Ampère 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen NUROFEN 200 mg, 200 mg Orodispersible tablet Oral use HEALTHCARE FRANCE comprimé 15, rue Ampère orodispersible 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen NUROFEN 400 mg, 400 mg Capsule, soft Oral use HEALTHCARE FRANCE capsule molle 15, rue Ampère 91748 Massy Cedex France

82

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France RECKITT BENCKISER Ibuprofen NUROFEN 400 mg, 400 mg Coated tablet Oral use HEALTHCARE FRANCE comprimé enrobé 15, rue Ampère 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen NUROFEN RHUME, 200 mg Film-coated tablet Oral use HEALTHCARE FRANCE pseudoephedrine comprimé pelliculé 15, rue Ampère 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen NUROFENCAPS 200 mg, 200 mg Capsule, soft Oral use HEALTHCARE FRANCE capsule molle 15, rue Ampère 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen NUROFENCAPS 400 400 mg Capsule, soft Oral use HEALTHCARE FRANCE mg, capsule molle 15, rue Ampère 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen lysinate NUROFENFEM 400 mg, 400 mg Film-coated tablet Oral use HEALTHCARE FRANCE comprimé pelliculé 15, rue Ampère 91748 Massy Cedex France

83

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France RECKITT BENCKISER Ibuprofen NUROFENFLASH 200 200 mg Film-coated tablet Oral use HEALTHCARE FRANCE mg, comprimé pelliculé 15, rue Ampère 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen NUROFENFLASH 400 400 mg Film-coated tablet Oral use HEALTHCARE FRANCE mg, comprimé pelliculé 15, rue Ampère 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen NUROFENFLASH 400 400 mg Powder for oral Oral use HEALTHCARE FRANCE mg, poudre pour solution 15, rue Ampère solution buvable en 91748 Massy Cedex sachet France France RECKITT BENCKISER Ibuprofen NUROFENTABS 200 mg, 200 mg Orodispersible tablet Oral use HEALTHCARE FRANCE comprimé 15, rue Ampère orodispersible 91748 Massy Cedex France France RECKITT BENCKISER Ibuprofen NUROFLASH 200 mg, 200 mg Capsule, soft Oral use HEALTHCARE FRANCE capsule molle 15, rue Ampère 91748 Massy Cedex France

84

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France WYETH SANTE FAMILIALE Ibuprofen RHINADVIL RHUME 200 mg Coated tablet Oral use Coeur Défense - Tour A - La pseudoephedrine IBUPROFENE/PSEUDOE Défense 4 PHEDRINE, comprimé 110, Esplanade du Général enrobé de Gaulle 92931 Paris La Défense Cedex France France PFIZER SANTE FAMILIALE Ibuprofen RHINADVILTAB, 200 mg Coated tablet Oral use 23-25, avenue du Docteur pseudoephedrine comprimé enrobé Lannelongue 75014 Paris France France RECKITT BENCKISER Ibuprofen RHINUREFLEX, 200 mg Film-coated tablet Oral use HEALTHCARE FRANCE pseudoephedrine comprimé pelliculé 15, rue Ampère 91748 Massy Cedex France France ZAMBON FRANCE Ibuprofen SPEDIFEN 200 mg, 200 mg Tablet Oral use 13, rue René Jacques comprimé 92138 Issy-les-Moulineaux Cedex France France ZAMBON FRANCE Ibuprofen SPEDIFEN 200 mg, 200 mg Granules for oral Oral use 13, rue René Jacques granulés pour solution solution 92138 Issy-les-Moulineaux buvable en sachet-dose Cedex France

85

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France ZAMBON FRANCE Ibuprofen SPEDIFEN 400 mg, 400 mg Film-coated tablet Oral use 13, rue René Jacques comprimé pelliculé 92138 Issy-les-Moulineaux Cedex France France ZAMBON FRANCE Ibuprofen SPEDIFEN 400 mg, 400 mg Granules for oral Oral use 13, rue René Jacques granulés pour solution solution 92138 Issy-les-Moulineaux buvable en sachet-dose Cedex France France ZAMBON FRANCE Ibuprofen SPIFEN 200 mg, 200 mg Tablet Oral use 13, rue René Jacques comprimé 92138 Issy-les-Moulineaux Cedex France France ZAMBON FRANCE Ibuprofen SPIFEN 200 mg, 200 mg Granules for oral Oral use 13, rue René Jacques granulés pour solution solution 92138 Issy-les-Moulineaux buvable en sachet-dose Cedex France France ZAMBON FRANCE Ibuprofen SPIFEN 400 mg, 400 mg Film-coated tablet Oral use 13, rue René Jacques comprimé pelliculé 92138 Issy-les-Moulineaux Cedex France

86

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

France ZAMBON FRANCE Ibuprofen SPIFEN 400 mg, 400 mg Granules for oral Oral use 13, rue René Jacques granulés pour solution solution 92138 Issy-les-Moulineaux buvable en sachet-dose Cedex France France Bristol Myers Squibb Ibuprofen UPFEN 200 mg, 200 mg Film-coated tablet Oral use 3, rue Joseph Monier comprimé pelliculé 92500 Rueil-Malmaison France Germany 1 A Pharma GmbH Ibuprofen Ibuprofen - 1 A Pharma 20 mg Oral suspension Oral use Keltenring 1 + 3 20 mg/ml Suspension 82041 Oberhaching zum Einnehmen Germany Germany 1 A Pharma GmbH Ibuprofen Ibu 600 - 1 A Pharma 600 mg Film-coated tablet Oral use Keltenring 1 + 3 82041 Oberhaching Germany Germany 1 A Pharma GmbH Ibuprofen Ibu 400 - 1 A Pharma 400 mg Film-coated tablet Oral use Keltenring 1 + 3 82041 Oberhaching Germany Germany 1 A Pharma GmbH Ibuprofen Ibu 400 akut - 1 A 400 mg Film-coated tablet Oral use Keltenring 1 + 3 Pharma 82041 Oberhaching Germany

87

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany 1 A Pharma GmbH Ibuprofen Ibu 800 ret - 1 A 800 mg Prolonged-release Oral use Keltenring 1 + 3 Pharma tablet 82041 Oberhaching Germany Germany 1 A Pharma GmbH Ibuprofen Ibu 800 - 1 A Pharma 800 mg Film-coated tablet Oral use Keltenring 1 + 3 82041 Oberhaching Germany Germany 1 A Pharma GmbH Ibuprofen Ibuprofen - 1 A Pharma 40 mg Oral suspension Oral use Keltenring 1 + 3 40 mg/ml Suspension 82041 Oberhaching zum Einnehmen Germany Germany Abbott Arzneimittel GmbH Ibuprofen Brufen 40 mg/ml 40 mg Oral suspension Oral use Freundallee 9A Suspension zum 30173 Hannover Einnehmen Germany Germany AbZ-Pharma GmbH Ibuprofen Ibuprofen AbZ 2 % Saft 20 mg/ml Syrup Oral use Graf-Arco-Str. 3 89079 Ulm Germany Germany AbZ-Pharma GmbH Ibuprofen Ibuprofen AbZ 600 mg 600 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Filmtablette 89079 Ulm Germany Germany AbZ-Pharma GmbH Ibuprofen Ibu-Lysin AbZ Migräne 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 684 mg Filmtabletten 89079 Ulm Germany

88

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany AbZ-Pharma GmbH Ibuprofen Ibuprofen-CT 4 % 40 mg/ml Syrup Oral use Graf-Arco-Str. 3 Kindersaft 89079 Ulm Germany Germany AbZ-Pharma GmbH Ibuprofen Ibuprofen AbZ 800 mg 800 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Filmtabletten 89079 Ulm Germany Germany AbZ-Pharma GmbH Ibuprofen Ibu-Lysin-CT 342 mg 200 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Filmtabletten 89079 Ulm Germany Germany AbZ-Pharma GmbH Ibuprofen Ibuprofen-CT 200 mg 200 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Filmtabletten 89079 Ulm Germany Germany AbZ-Pharma GmbH Ibuprofen ibuprofen-ct 600 mg 600 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Filmtabletten 89079 Ulm Germany Germany AbZ-Pharma GmbH Ibuprofen Ibu-Lysin-CT 684 mg 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Filmtabletten 89079 Ulm Germany Germany AbZ-Pharma GmbH Ibuprofen Ibuprofen AbZ 4 % Saft 40 mg/ml Syrup Oral use Graf-Arco-Str. 3 89079 Ulm Germany

89

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany AbZ-Pharma GmbH Ibuprofen ibuprofen-ct 400 mg 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Filmtablette 89079 Ulm Germany Germany AbZ-Pharma GmbH Ibuprofen ibuprofen-ct 500 mg 500 mg Suppository Rectal use Graf-Arco-Str. 3 Zäpfchen 89079 Ulm Germany Germany AbZ-Pharma GmbH Ibuprofen ibuprofen-ct 400 mg 400 mg Prolonged-release Oral use Graf-Arco-Str. 3 Retardkapsel capsule, hard 89079 Ulm Germany Germany AbZ-Pharma GmbH Ibuprofen Ibuprofen-CT 800 mg 800 mg Prolonged-release Oral use Graf-Arco-Str. 3 Retardtabletten tablet 89079 Ulm Germany Germany acis Arzneimittel GmbH Ibuprofen Ibu-acis 600 mg 600 mg Film-coated tablet Oral use Lil-Dagover-Ring 7 Filmtabletten 82031 Grünwald Germany Germany acis Arzneimittel GmbH Ibuprofen Ibu-acis 800 mg retard 800 mg Prolonged-release Oral use Lil-Dagover-Ring 7 tablet 82031 Grünwald Germany

90

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Actavis Deutschland GmbH Ibuprofen Ibuprofen-Actavis 600 600 mg Film-coated tablet Oral use & Co. KG mg Filmtabletten Willy-Brandt-Allee 2 81829 München Germany Germany Actavis Deutschland GmbH Ibuprofen Ibuprofen-Actavis 400 mg Granules for oral Oral use & Co. KG Granulat 400 mg solution Willy-Brandt-Allee 2 81829 München Germany Germany Actavis Deutschland GmbH Ibuprofen Ibuprofen-Actavis 400 400 mg Film-coated tablet Oral use & Co. KG mg Filmtabletten Willy-Brandt-Allee 2 81829 München Germany Germany Actavis Deutschland GmbH Ibuprofen Ibuprofen-Actavis 600 mg Granules for oral Oral use & Co. KG Granulat 600 mg solution Willy-Brandt-Allee 2 81829 München Germany Germany Actavis Deutschland GmbH Ibuprofen Ibuprofen-Actavis 800 800 mg Film-coated tablet Oral use & Co. KG mg Filmtabletten Willy-Brandt-Allee 2 81829 München Germany

91

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Actavis Group PTC ehf Ibuprofen Ibuprofen-Actavis 200 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 mg Filmtabletten 220 Hafnarfjörður Iceland Germany ADL Pharma GmbH Ibuprofen Ibuprofen PB 400 mg 400 mg Film-coated tablet Oral use Borsigstr. 3 71263 Weil der Stadt Germany Germany ADL Pharma GmbH Ibuprofen Ibuprofen PB 600 mg 600 mg Film-coated tablet Oral use Borsigstr. 3 71263 Weil der Stadt Germany Germany ALIUD PHARMA GmbH Ibuprofen Ibuprofen AL 40 mg/ml 40 mg Oral suspension Oral use Gottlieb-Daimler-Str. 19 Suspension zum 89150 Laichingen Einnehmen Germany Germany ALIUD PHARMA GmbH Ibuprofen Ibuprofen AL 400 400 mg Film-coated tablet Oral use Gottlieb-Daimler-Str. 19 89150 Laichingen Germany Germany ALIUD PHARMA GmbH Ibuprofen Ibuprofen AL 800 retard 800 mg Prolonged-release Oral use Gottlieb-Daimler-Str. 19 tablet 89150 Laichingen Germany Germany ALIUD PHARMA GmbH Ibuprofen Ibuprofen AL 800 800 mg Film-coated tablet Oral use Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

92

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany ALIUD PHARMA GmbH Ibuprofen Ibuprofen AL 600 600 mg Film-coated tablet Oral use Gottlieb-Daimler-Str. 19 89150 Laichingen Germany Germany ALIUD PHARMA GmbH Ibuprofen natrium Ibuprofen AL 600 694 mg Suppository Rectal use Gottlieb-Daimler-Str. 19 Zäpfchen 89150 Laichingen Germany Germany Aspire Pharma Limited Ibuprofen Ibuprofen ASPIRE 40 40 mg Oral suspension Oral use 102 High Street mg/ml Suspension zum GB-GU7 1DS GODALMING, Einnehmen SURREY United Kingdom Germany axcount Generika GmbH Ibuprofen Ibuprofen Axcount 800 800 mg Prolonged-release Oral use Max-Planck-Str. 36d mg retard tablet 61381 Friedrichsdorf Germany Germany axcount Generika GmbH Ibuprofen Ibuprofen axcount 400 400 mg Film-coated tablet Oral use Max-Planck-Str. 36d mg akut 61381 Friedrichsdorf Germany Germany axcount Generika GmbH Ibuprofen Fibraflex 800 mg 800 mg Film-coated tablet Oral use Max-Planck-Str. 36d 61381 Friedrichsdorf Germany

93

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany axcount Generika GmbH Ibuprofen Ibuprofen axcount 200 200 mg Film-coated tablet Oral use Max-Planck-Str. 36d mg akut 61381 Friedrichsdorf Germany Germany axcount Generika GmbH Ibuprofen Ibuprofen Axcount 600 600 mg Film-coated tablet Oral use Max-Planck-Str. 36d mg 61381 Friedrichsdorf Germany Germany AxiCorp Pharma GmbH Ibuprofen ibutop 400 mg 400 mg Film-coated tablet Oral use Max-Planck-Str. 36b Schmerztabletten 61381 Friedrichsdorf Germany Germany AxiCorp Pharma GmbH Ibuprofen ibutop 200 mg 200 mg Film-coated tablet Oral use Max-Planck-Str. 36b Schmerztabletten 61381 Friedrichsdorf Germany Germany Bayer Vital GmbH Ibuprofen Aktren Spezial 400 mg Capsule, soft Oral use Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany Germany Bayer Vital GmbH Ibuprofen Aktren forte 400 mg Film-coated tablet Oral use Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany Germany Bayer Vital GmbH Ibuprofen Aktren Mobil 400 mg Film-coated tablet Oral use Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany

94

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Bayer Vital GmbH Ibuprofen Aktren 200 mg Coated tablet Oral use Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany Germany Bayer Vital GmbH Ibuprofen Aktren 200 mg Coated tablet Oral use Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany Germany bene - Arzneimittel GmbH Ibuprofen ib-u-ron 75 mg 75 mg Suppository Rectal use Herterichstr. 1 - 3 Zäpfchen 81479 München Germany Germany bene - Arzneimittel GmbH Ibuprofen Ibuprofen bene 150 mg 150 mg Suppository Rectal use Herterichstr. 1 - 3 Zäpfchen 81479 München Germany Germany Dolorgiet GmbH & Co. KG Ibuprofen ib-u-ron akut 400 mg 400 mg Capsule, soft Oral use Otto-von-Guericke-Str. 1 Weichkapseln 53757 Sankt Augustin Germany Germany bene - Arzneimittel GmbH Ibuprofen ib-u-ron 150 mg 150 mg Suppository Rectal use Herterichstr. 1 - 3 Zäpfchen 81479 München Germany Germany bene - Arzneimittel GmbH Ibuprofen Ibuprofen bene 75 mg 75 mg Suppository Rectal use Herterichstr. 1 - 3 Zäpfchen 81479 München Germany

95

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Berlin-Chemie AG Ibuprofen EUDORLIN Extra 400 mg Film-coated tablet Oral use Glienicker Weg 125 Ibuprofen- 12489 Berlin Schmerztabletten Germany Germany Berlin-Chemie AG Ibuprofen MENSOTON gegen 200 mg Film-coated tablet Oral use Glienicker Weg 125 Regelschmerzen 12489 Berlin Germany Germany Berlin-Chemie AG Ibuprofen Eudorlin Ibuprofen 40 40 mg/ml Oral suspension Oral use Glienicker Weg 125 mg/ml Suspension zum 12489 Berlin Einnehmen Germany Germany Berlin-Chemie AG Ibuprofen Eudorlin Ibuprofen 20 20 mg/ml Oral suspension Oral use Glienicker Weg 125 mg/ml Suspension zum 12489 Berlin Einnehmen Germany Germany Berlin-Chemie AG Ibuprofen EUDORLIN Migräne 400 mg Film-coated tablet Oral use Glienicker Weg 125 12489 Berlin Germany Germany betapharm Arzneimittel Ibuprofen Ibubeta retard 800 mg Prolonged-release Oral use GmbH tablet Kobelweg 95 86156 Augsburg Germany

96

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany betapharm Arzneimittel Ibuprofen Ibubeta 800 800 mg Film-coated tablet Oral use GmbH Kobelweg 95 86156 Augsburg Germany Germany betapharm Arzneimittel Ibuprofen Ibubeta 600 600 mg Film-coated tablet Oral use GmbH Kobelweg 95 86156 Augsburg Germany Germany betapharm Arzneimittel Ibuprofen Ibubeta 400 400 mg Film-coated tablet Oral use GmbH Kobelweg 95 86156 Augsburg Germany Germany Blanco-Pharma GmbH Ibuprofen Ibusan 400 mg 400 mg Film-coated tablet Oral use Oasenweg 3 Filmtabletten 25474 Ellerbek Germany Germany Boehringer Ingelheim Ibuprofen Ibuprofen Boehringer 400 mg Capsule, soft Oral use International GmbH Ingelheim 400 mg Binger Str. 148 - 173 Weichkapsel 55216 Ingelheim Germany

97

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Boehringer Ingelheim Ibuprofen BoxaGrippal 200 mg/ 200 mg Film-coated tablet Oral use International GmbH pseudoephedrine 30 mg 30 mg Binger Str. 148 - 173 hydrochloride 55216 Ingelheim Germany Germany Boehringer Ingelheim Ibuprofen Thomapyrin TENSION 400 mg Film-coated tablet Oral use Pharma GmbH & Co. KG Binger Str. 148 - 173 55216 Ingelheim Germany Germany Boehringer Ingelheim Ibuprofen TOMIBU 400 mg Film-coated tablet Oral use Pharma GmbH & Co. KG Binger Str. 148 - 173 55216 Ingelheim Germany Germany Bronzactiv Pharma GmbH Ibuprofen lysine Ibuaktiv 200 mg 342 mg Effervescent tablet Oral use Carl-von-Linde-Str. 30 85716 Unterschleißheim Germany Germany Denk Pharma GmbH & Co. Ibuprofen Ibuprofen Denk 600 mg 600 mg Film-coated tablet Oral use KG Filmtabletten Prinzregentenstr. 79 81675 München Germany

98

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Omega Pharma Deutschland Ibuprofen Optalidon Ibu 200 mg 200 mg Film-coated tablet Oral use GmbH Benzstr. 25 71083 Herrenberg Germany Germany Dexcel Pharma GmbH Ibuprofen Ibu Atid 400 mg 400 mg Film-coated tablet Oral use Carl-Zeiss-Str. 2 Filmtabletten 63755 Alzenau Germany Germany Dexcel Pharma GmbH Ibuprofen IbuDex 400 mg 400 mg Film-coated tablet Oral use Carl-Zeiss-Str. 2 63755 Alzenau Germany Germany Dexcel Pharma GmbH Ibuprofen Ibuprofen Atid 600 mg 600 mg Film-coated tablet Oral use Carl-Zeiss-Str. 2 63755 Alzenau Germany Germany Dexcel Pharma GmbH Ibuprofen Ibuprofen Atid 800 mg 800 mg Film-coated tablet Oral use Carl-Zeiss-Str. 2 63755 Alzenau Germany Germany Dexcel Pharma GmbH Ibuprofen IbuDex 200 mg 200 mg Film-coated tablet Oral use Carl-Zeiss-Str. 2 63755 Alzenau Germany

99

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Dolorgiet GmbH & Co. KG Ibuprofen Dolgit Schmerzdragees 200 mg Coated tablet Oral use Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany Germany Dolorgiet GmbH & Co. KG Ibuprofen Schmerz-Dolgit 400 mg Capsule, soft Oral use Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany Germany Dolorgiet GmbH & Co. KG Ibuprofen Dolgit 200 200 mg Coated tablet Oral use Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany Germany Dolorgiet GmbH & Co. KG Ibuprofen Dolgit 800 800 mg Coated tablet Oral use Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany Germany Dolorgiet GmbH & Co. KG Ibuprofen Dolgit 400 400 mg Coated tablet Oral use Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany Germany Dolorgiet GmbH & Co. KG Ibuprofen Dolgit Schmerzkapseln 400 mg Capsule, soft Oral use Otto-von-Guericke-Str. 1 gegen Schmerzen und 53757 Sankt Augustin Fieber Germany Germany Dolorgiet GmbH & Co. KG Ibuprofen Dolgit 600 600 mg Coated tablet Oral use Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

100

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Dr. R. Pfleger Chemische Ibuprofen Gyno-Neuralgin 400 mg Film-coated tablet Oral use Fabrik GmbH Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany Germany Dr. R. Pfleger Chemische Ibuprofen Neuralgin extra Ibu- 400 mg Coated tablet Oral use Fabrik Lysinat GmbH Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany Germany Dr. R. Pfleger Chemische Ibuprofen Ibuprofen Pfleger 400 400 mg Coated tablet Oral use Fabrik mg Filmtabletten GmbH Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany Germany Dr. Kade Pharmazeutische Ibuprofen Urem forte 400 mg Coated tablet Oral use Fabrik GmbH Rigistr. 2 12277 Berlin Germany

101

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Dr. Kade Pharmazeutische Ibuprofen Ibu KD 400 mg 400 mg Coated tablet Oral use Fabrik GmbH Rigistr. 2 12277 Berlin Germany Germany Dr. Kade Pharmazeutische Ibuprofen Ibu KD 800 mg 800 mg Coated tablet Oral use Fabrik GmbH Rigistr. 2 12277 Berlin Germany Germany Dr. Kade Pharmazeutische Ibuprofen Ibu KD 600 mg 600 mg Coated tablet Oral use Fabrik GmbH Rigistr. 2 12277 Berlin Germany Germany Dr. Kade Pharmazeutische Ibuprofen Ibu KD 400 mg akut 400 mg Coated tablet Oral use Fabrik GmbH Rigistr. 2 12277 Berlin Germany Germany Fair-Med Healthcare GmbH Ibuprofen Ibuprofen FAIR-MED 600 mg Film-coated tablet Oral use Planckstr. 13 Healthcare 600 mg 22765 Hamburg Filmtabletten Germany

102

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Fair-Med Healthcare GmbH Ibuprofen Ibuprofen FAIR-MED 400 mg Film-coated tablet Oral use Planckstr. 13 Healthcare 400 mg 22765 Hamburg Filmtabletten Germany Germany Fair-Med Healthcare GmbH Ibuprofen Ibuprofen FAIR-MED 200 mg Film-coated tablet Oral use Planckstr. 13 Healthcare 200 mg 22765 Hamburg Filmtabletten Germany Germany Farmalider S.A. Ibuprofen Ibuprofen LIDERFARM 20 mg/ml Oral suspension Oral use C/ Aragoneses, 15 20 mg/ml Suspension Alcobendas (Madrid), 28108 zum Einnehmen Spain Germany Farmalider S.A. Ibuprofen Ibuprofen LIDERFARM 40 mg/ml Oral suspension Oral use C/ Aragoneses, 15 40 mg/ml Suspension Alcobendas (Madrid), 28108 zum Einnehmen Spain Germany Farmalider S.A. Ibuprofen Ibuprofen LIDERFARM 40 mg/ml Oral suspension Oral use C/ Aragoneses, 15 40 mg/ml Suspension Alcobendas (Madrid), 28108 zum Einnehmen Spain Germany Farmalider S.A. Ibuprofen Ibuprofen LIDERFARM 40 mg/ml Oral suspension Oral use C/ Aragoneses, 15 40 mg/ml Suspension Alcobendas (Madrid), 28108 zum Einnehmen Spain Germany Farmalider S.A. Ibuprofen Ibuprofen LIDERFARM 20 mg/ml Oral suspension Oral use C/ Aragoneses, 15 20 mg/ml Suspension Alcobendas (Madrid), 28108 zum Einnehmen Spain

103

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Galpharm Healthcare Ibuprofen Ibuprofen Galpharm 400 mg Film-coated tablet Oral use Limited 400 mg Filmtabletten EX33 2DL Wrafton Braunton Devon United Kingdom Germany Galpharm Healthcare Ibuprofen Ibuprofen Galpharm 200 mg Film-coated tablet Oral use Limited 200 mg Filmtabletten EX33 2DL Wrafton Braunton Devon United Kingdom Germany Gebro Pharma GmbH Dexibuprofen Dolomagon 400 mg 400 mg Film-coated tablet Oral use Bahnhofbichl 13 Filmtabletten 6391 Fieberbrunn Austria Germany Gebro Pharma GmbH Dexibuprofen Dolomagon 300 mg 300 mg Film-coated tablet Oral use Bahnhofbichl 13 Filmtabletten 6391 Fieberbrunn Austria Germany Georg Simons GmbH Ibuprofen Dismenol N 200 mg Film-coated tablet Oral use Eckenheimer Landstr. 100- 104 60318 Frankfurt am Main Germany

104

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Hemopharm GmbH Ibuprofen lysine Ibu-Hemopharm 200mg 342 mg Effervescent tablet Oral use Königsteiner Str. 2 Brausetabletten 61350 Bad Homburg v.d.H. Germany Germany Hemopharm GmbH Ibuprofen Ibu-Hemopharm 400mg 400 mg Film-coated tablet Oral use Königsteiner Str. 2 Filmtabletten 61350 Bad Homburg v.d.H. Germany Germany Hennig Arzneimittel GmbH & Ibuprofen Esprenit 800 mg retard 800 mg Prolonged-release Oral use Co. KG Retardtabletten tablet Liebigstr. 1 65439 Flörsheim Germany Germany Hennig Arzneimittel GmbH & Ibuprofen Esprenit 600mg 600 mg Film-coated tablet Oral use Co. KG Filmtabletten Liebigstr. 1 65439 Flörsheim Germany Germany Hennig Arzneimittel GmbH & Ibuprofen Esprenit 400mg 400 mg Film-coated tablet Oral use Co. KG Filmtabletten Liebigstr. 1 65439 Flörsheim Germany Germany Heumann Pharma GmbH & Ibuprofen Ibuprofen Heumann 400 mg Film-coated tablet Oral use Co. Generika KG Schmerztabletten Südwestpark 50 400mg Filmtabletten 90449 Nürnberg Germany

105

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Heumann Pharma GmbH & Ibuprofen Ibuprofen Heumann 800 mg Film-coated tablet Oral use Co. Generika KG 800mg Filmtabletten Südwestpark 50 90449 Nürnberg Germany Germany Heumann Pharma GmbH & Ibuprofen Ibuprofen Heumann 200 mg Film-coated tablet Oral use Co. Generika KG 200mg Filmtabletten Südwestpark 50 90449 Nürnberg Germany Germany Heumann Pharma GmbH & Ibuprofen Ibuprofen Heumann 600 mg Film-coated tablet Oral use Co. Generika KG 600mg Filmtabletten Südwestpark 50 90449 Nürnberg Germany Germany Hexal AG Ibuprofen Ibu-LysinHexal 684 mg 400 mg Film-coated tablet Oral use Industriestr. 25 Filmtabletten 83607 Holzkirchen Germany Germany Hexal AG Ibuprofen Ibuhexal 400 400 mg Film-coated tablet Oral use Industriestr. 25 83607 Holzkirchen Germany Germany Hexal AG Ibuprofen sodium Ibuhexal 600 694 mg Suppository Rectal use Industriestr. 25 83607 Holzkirchen Germany

106

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Hexal AG Ibuprofen Ibuhexal 800 800 mg Film-coated tablet Oral use Industriestr. 25 83607 Holzkirchen Germany Germany Hexal AG Ibuprofen Ibuhexal 600 600 mg Film-coated tablet Oral use Industriestr. 25 83607 Holzkirchen Germany Germany Hexal AG Ibuprofen Ibuhexal retard 800 mg Prolonged-release Oral use Industriestr. 25 tablet 83607 Holzkirchen Germany Germany KSK-Pharma Vertriebs AG Ibuprofen ibu 200 KSK 200 mg Film-coated tablet Oral use Finkenstr. 1 76327 Pfinztal-Berghausen Germany Germany KSK-Pharma Vertriebs AG Ibuprofen ibu-KSK 600mg 600 mg Film-coated tablet Oral use Finkenstr. 1 76327 Pfinztal-Berghausen Germany Germany McNeil GmbH & Co.oHG Ibuprofen Dolormin 200 mg Film-coated tablet Oral use Johnson & Johnson Platz 2 Schmerztabletten 41470 Neuss Germany Germany McNeil GmbH & Co.oHG Ibuprofen Dolormin Migräne 200 mg Effervescent granules Oral use Johnson & Johnson Platz 2 schnell lösliches 41470 Neuss Granulat Germany

107

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany McNeil GmbH & Co.oHG Ibuprofen Dolormin bei 200 mg Effervescent granules Oral use Johnson & Johnson Platz 2 Erkältungsschmerzen 41470 Neuss und Fieber Germany Germany McNeil GmbH & Co.oHG Ibuprofen Dolormin 342 mg Film-coated tablet Oral use Johnson & Johnson Platz 2 Schmerztabletten 41470 Neuss Germany Germany McNeil GmbH & Co.oHG Ibuprofen sodium Dolormin Migräne 694 mg Suppository Rectal use Johnson & Johnson Platz 2 Zäpfchen 41470 Neuss Germany Germany McNeil GmbH & Co.oHG Ibuprofen Tispol Ibu-DD 400 mg Film-coated tablet Oral use Johnson & Johnson Platz 2 41470 Neuss Germany Germany McNeil GmbH & Co.oHG Ibuprofen Ibu 342 Lysinat JJ 342 mg Film-coated tablet Oral use Johnson & Johnson Platz 2 41470 Neuss Germany Germany McNeil GmbH & Co.oHG Ibuprofen Dolormin Migräne 400 mg Film-coated tablet Oral use Johnson & Johnson Platz 2 Filmtabletten 41470 Neuss Germany Germany McNeil GmbH & Co.oHG Ibuprofen Dolormin instant schnell 200 mg Effervescent granules Oral use Johnson & Johnson Platz 2 lösliches Granulat 41470 Neuss Germany

108

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany McNeil GmbH & Co.oHG Ibuprofen lysine Dolormin extra 684 mg Film-coated tablet Oral use Johnson & Johnson Platz 2 41470 Neuss Germany Germany McNeil GmbH & Co.oHG Ibuprofen lysine Dolormin extra 684 mg Film-coated tablet Oral use Johnson & Johnson Platz 2 41470 Neuss Germany Germany Medphano Arzneimittel Ibuprofen Ibuprofen-mp 600 600 mg Film-coated tablet Oral use GmbH Maienbergstr. 10-12 15562 Rüdersdorf Germany Germany Medphano Arzneimittel Ibuprofen Miralgin 400 mg 400 mg Film-coated tablet Oral use GmbH Filmtabletten Maienbergstr. 10-12 15562 Rüdersdorf Germany Germany Mepha Investigacao, Ibuprofen Irfen 200 mg 200 mg Film-coated tablet Oral use Desenvolvimento e Filmtabletten Fabricacao Farmaceutica, Lda. Lagos Park, Edificio 5A, Piso 2 2740-298 PORTO SALVO Portugal

109

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Mepha Investigacao, Ibuprofen Irfen 400 mg 400 mg Film-coated tablet Oral use Desenvolvimento e Filmtabletten Fabricacao Farmaceutica, Lda. Lagos Park, Edificio 5A, Piso 2 2740-298 PORTO SALVO Portugal Germany Mibe GmbH Arzneimittel Ibuprofen Fibraflex 600 mg 600 mg Film-coated tablet Oral use Münchener Str. 15 06796 Brehna Germany Germany Mibe GmbH Arzneimittel Ibuprofen Jenaprofen 600 mg 600 mg Film-coated tablet Oral use Münchener Str. 15 06796 Brehna Germany Germany Mibe GmbH Arzneimittel Ibuprofen Fibraflex 800 mg retard 800 mg Prolonged-release Oral use Münchener Str. 15 tablet 06796 Brehna Germany Germany Mibe GmbH Arzneimittel Ibuprofen Fibraflex 400 mg 400 mg Film-coated tablet Oral use Münchener Str. 15 06796 Brehna Germany Germany Mibe GmbH Arzneimittel Ibuprofen Jenaprofen 400 mg 400 mg Film-coated tablet Oral use Münchener Str. 15 06796 Brehna Germany

110

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Mylan dura GmbH Ibuprofen Ibuprofen dura 800 mg 800 mg Film-coated tablet Oral use Wittichstr. 6 Filmtabletten 64295 Darmstadt Germany Germany Mylan dura GmbH Ibuprofen Ibuprofen dura 400 mg 400 mg Film-coated tablet Oral use Wittichstr. 6 Filmtabletten 64295 Darmstadt Germany Germany Mylan dura GmbH Ibuprofen Ibuprofen dura 600mg 600 mg Film-coated tablet Oral use Wittichstr. 6 Filmtabletten 64295 Darmstadt Germany Germany Pfizer Consumer Healthcare Ibuprofen Spalt Kopfschmerz 200 mg Capsule, soft Oral use GmbH Linkstr. 10 10785 Berlin Germany Germany Pfizer Consumer Healthcare Ibuprofen Spalt Migräne 400 mg Capsule, soft Oral use GmbH Linkstr. 10 10785 Berlin Germany Germany Pfizer Consumer Healthcare Ibuprofen Spalt Mobil 400 mg Capsule, soft Oral use GmbH Linkstr. 10 10785 Berlin Germany

111

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Pfizer Consumer Healthcare Ibuprofen SpaltGrippal 30 mg/200 200 mg Film-coated tablet Oral use GmbH pseudoephedrine mg überzogene 30 mg Linkstr. 10 hydrochloride Tabletten 10785 Berlin Germany Germany Pfizer Consumer Healthcare Ibuprofen Spalt Forte 400 mg Capsule, soft Oral use GmbH Linkstr. 10 10785 Berlin Germany Germany ratiopharm GmbH Ibuprofen Ibuprofen-ratio 200 mg 200 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Filmtabletten 89079 Ulm Germany Germany ratiopharm GmbH Ibuprofen Ibu-ratiopharm 800 mg 800 mg Prolonged-release Oral use Graf-Arco-Str. 3 Retardtabletten tablet 89079 Ulm Germany Germany ratiopharm GmbH Ibuprofen Ibu-ratiopharm 400 mg 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 akut Schmerztabletten 89079 Ulm Germany Germany ratiopharm GmbH Ibuprofen Ibu-ratiopharm 800 mg 800 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Filmtabletten 89079 Ulm Germany

112

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany ratiopharm GmbH Ibuprofen lysine IBU-LYSIN-ratiopharm 342 mg Film-coated tablet Oral use Graf-Arco-Str. 3 342 mg Filmtabletten 89079 Ulm Germany Germany ratiopharm GmbH Ibuprofen IBU-ratiopharm 20 mg/ml Syrup oral use Graf-Arco-Str. 3 Fiebersaft für Kinder 2 89079 Ulm % Germany Germany ratiopharm GmbH Ibuprofen IBU-ratiopharm 40 mg/ml Syrup oral use Graf-Arco-Str. 3 Fiebersaft für Kinder 4 89079 Ulm % Germany Germany ratiopharm GmbH Ibuprofen lysine IBU-ratiopharm Lysinat 500 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Schmerztabletten 500 89079 Ulm mg Germany Germany ratiopharm GmbH Ibuprofen lysine IBU-LYSIN-ratiopharm 684 mg Film-coated tablet Oral use Graf-Arco-Str. 3 684 mg Filmtabletten 89079 Ulm Germany Germany ratiopharm GmbH Ibuprofen Ibu-ratiopharm 600 mg 600 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Filmtabletten 89079 Ulm Germany Germany ratiopharm GmbH Ibuprofen Ibuprofen-ratio 400 mg 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Filmtabletten 89079 Ulm Germany

113

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany ratiopharm GmbH Ibuprofen Ibu-ratiopharm 400 mg 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 Filmtabletten 89079 Ulm Germany Germany Reckitt Benckiser Ibuprofen Nurofen Ibuprofen 400 400 mg Coated tablet Oral use Deutschland GmbH mg überzogene Theodor-Heuss-Anlage 12 Tabletten 68165 Mannheim Germany Germany Reckitt Benckiser Ibuprofen Nurofen 40 mg/ml 40 mg/ml Oral suspension Oral use Deutschland GmbH Suspension zum Theodor-Heuss-Anlage 12 Einnehmen 68165 Mannheim Germany Germany Reckitt Benckiser Ibuprofen Nurofen Liquid 200 mg 200 mg Capsule, soft Oral use Deutschland GmbH Weichkapseln Theodor-Heuss-Anlage 12 68165 Mannheim Germany Germany Reckitt Benckiser Ibuprofen Nurofen 200 mg 200 mg Orodispersible tablet Oral use Deutschland GmbH Schmelztabletten Mint Theodor-Heuss-Anlage 12 68165 Mannheim Germany

114

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Reckitt Benckiser Ibuprofen Nurofen 200 mg 200 mg Orodispersible tablet Oral use Deutschland GmbH Schmelztabletten Theodor-Heuss-Anlage 12 Lemon 68165 Mannheim Germany Germany Reckitt Benckiser Ibuprofen lysine Nurofen Immedia 400 683,34 mg Powder for oral Oral use Deutschland GmbH mg Pulver zur solution Theodor-Heuss-Anlage 12 Herstellung einer 68165 Mannheim Lösung zum Einnehmen Germany Germany Reckitt Benckiser Ibuprofen Nurofen Schmerz- und 40 mg/ml Oral suspension Oral use Deutschland GmbH Fiebersaft Erdbeer 40 Theodor-Heuss-Anlage 12 mg/ml Suspension zum 68165 Mannheim Einnehmen Germany Germany Reckitt Benckiser Ibuprofen Nurofen Immedia 200 200 mg Capsule, soft Oral use Deutschland GmbH mg Weichkapseln Theodor-Heuss-Anlage 12 68165 Mannheim Germany Germany Reckitt Benckiser Ibuprofen lysine Nurofen Immedia 400 684 mg Film-coated tablet Oral use Deutschland GmbH mg Filmtabletten Theodor-Heuss-Anlage 12 68165 Mannheim Germany

115

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Recordati Pharma GmbH Ibuprofen lysine Imbun Zäpfchen 500 mg Suppository Rectal use Eberhard-Finckh-Str. 55 89075 Ulm Germany Germany Recordati Pharma GmbH Ibuprofen Imbun retard 800 mg Prolonged-release Oral use Eberhard-Finckh-Str. 55 tablet 89075 Ulm Germany Germany Recordati Pharma GmbH Ibuprofen lysine Imbun 500mg 500 mg Film-coated tablet Oral use Eberhard-Finckh-Str. 55 Filmtabletten 89075 Ulm Germany Germany Recordati Pharma GmbH Ibuprofen lysine Imbun 1000mg 1000 mg Film-coated tablet Oral use Eberhard-Finckh-Str. 55 Filmtabletten 89075 Ulm Germany Germany Recordati Pharma GmbH Ibuprofen Imbun 800 mg 800 mg Prolonged-release Oral use Eberhard-Finckh-Str. 55 Retardtabletten tablet 89075 Ulm Germany Germany Sandoz Pharmaceuticals Ibuprofen Ibuprofen Sandoz 800 800 mg Prolonged-release Oral use GmbH mg Retardtabletten tablet Raiffeisenstr. 11 83607 Holzkirchen Germany

116

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Sandoz Pharmaceuticals Ibuprofen Anco 600mg 600 mg Film-coated tablet Oral use GmbH Filmtabletten Raiffeisenstr. 11 83607 Holzkirchen Germany Germany Sandoz Pharmaceuticals Ibuprofen Ibuprofen Sandoz 600 600 mg Film-coated tablet Oral use GmbH mg Filmtabletten Raiffeisenstr. 11 83607 Holzkirchen Germany Germany STADA Arzneimittel AG Ibuprofen Ibusustad 40 mg/ml 40 mg Oral suspension Oral use Stadastr. 2-18 Suspension zum 61118 Bad Vilbel Einnehmen Germany Germany STADA GmbH Ibuprofen Ibudolor 400 mg 400 mg Film-coated tablet Oral use Stadastr. 2-18 Filmtabletten 61118 Bad Vilbel Germany Germany STADA GmbH Ibuprofen Ibudolor 200 mg 200 mg Film-coated tablet Oral use Stadastr. 2-18 Filmtabletten 61118 Bad Vilbel Germany Germany STADA GmbH Ibuprofen Ibudolor 40 mg/ml 40 mg Oral suspension Oral use Stadastr. 2-18 Suspension zum 61118 Bad Vilbel Einnehmen Germany

117

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany STADA GmbH Ibuprofen Pfeil Zahnschmerz- 400 mg Film-coated tablet Oral use Stadastr. 2-18 Tabletten forte 400mg 61118 Bad Vilbel Filmtabletten Germany Germany Stadapharm GmbH Ibuprofen Ibuprofen STADA 40 40 mg Oral suspension Oral use Stadastr. 2-18 mg/ml Suspension zum 61118 Bad Vilbel Einnehmen Germany Germany Stadapharm GmbH Ibuprofen Ibuprofen Stada 600 600 mg Film-coated tablet Oral use Stadastr. 2-18 mg Filmtabletten 61118 Bad Vilbel Germany Germany Stadapharm GmbH Ibuprofen Ibuprofen STADA 400 mg Film-coated tablet Oral use Stadastr. 2-18 400mg Filmtabletten 61118 Bad Vilbel Germany Germany Stadapharm GmbH Ibuprofen sodium Ibuprofen STADA 600 694 mg Suppository Rectal use Stadastr. 2-18 mg Zäpfchen 61118 Bad Vilbel Germany Germany Stadapharm GmbH Ibuprofen Ibuprofen STADA 800 800 mg Prolonged-release Oral use Stadastr. 2-18 mg Retardtabletten tablet 61118 Bad Vilbel Germany Germany Strathmann GmbH & Co. KG Dexibuprofen Deltaran 200 mg 200 mg Film-coated tablet Oral use Sellhopsweg 1 Filmtabletten 22459 Hamburg Germany

118

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Strathmann GmbH & Co. KG Dexibuprofen Deltaran 300 mg 300 mg Film-coated tablet Oral use Sellhopsweg 1 Filmtabletten 22459 Hamburg Germany Germany Strathmann GmbH & Co. KG Dexibuprofen Deltaran 400 mg 400 mg Film-coated tablet Oral use Sellhopsweg 1 Filmtabletten 22459 Hamburg Germany Germany TAD Pharma GmbH Ibuprofen ibuTAD 800mg retard 800 mg Prolonged-release Oral use Heinz-Lohmann-Str. 5 tablet 27472 Cuxhaven Germany Germany TAD Pharma GmbH Ibuprofen ibuTAD 600mg 600 mg Film-coated tablet Oral use Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany Germany TAD Pharma GmbH Ibuprofen IbuTAD 800mg 800 mg Film-coated tablet Oral use Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany Germany TAD Pharma GmbH Ibuprofen IbuTAD 400 mg gegen 400 mg Film-coated tablet Oral use Heinz-Lohmann-Str. 5 Schmerzen 27472 Cuxhaven Germany Germany TAD Pharma GmbH Ibuprofen ibuTAD 400mg 400 mg Film-coated tablet Oral use Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany

119

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Temmler Pharma GmbH & Ibuprofen Novogent 400mg 400 mg Dispersible tablet Oral use Co. KG Trinktabletten Temmlerstr. 2 35039 Marburg Germany Germany Temmler Pharma GmbH & Ibuprofen Ibuprofen Temmler 200 200 mg Tablet Oral use Co. KG mg Temmlerstr. 2 35039 Marburg Germany Germany Temmler Pharma GmbH & Ibuprofen Novogent 600mg 600 mg Tablet Oral use Co. KG Trinktabletten Temmlerstr. 2 35039 Marburg Germany Germany Temmler Pharma GmbH & Ibuprofen Ibuprofen Temmler 400 400 mg Soluble tablet Oral use Co. KG mg Temmlerstr. 2 35039 Marburg Germany Germany Temmler Pharma GmbH & Ibuprofen Novogent 800mg 800 mg Tablet Oral use Co. KG Trinktabletten Temmlerstr. 2 35039 Marburg Germany

120

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Temmler Werke GmbH Ibuprofen Ibuflam 800 mg 800 mg Prolonged-release Oral use Weihenstephaner Str. 28 Retardtabletten tablet 81673 München Germany Germany Temmler Werke GmbH Ibuprofen dolomo-IBU TN 400 mg Film-coated tablet Oral use Weihenstephaner Str. 28 600 mg 81673 München Germany Germany Temmler Werke GmbH Ibuprofen Ibuprofen Klinge 600 mg Film-coated tablet Oral use Weihenstephaner Str. 28 600mg 81673 München Germany Germany Temmler Werke GmbH Ibuprofen Ibuklaph 800 mg 800 mg Film-coated tablet Oral use Weihenstephaner Str. 28 81673 München Germany Germany TEOFARMA S.R.L. Ibuprofen Tabalon 400mg 400 mg Film-coated tablet Oral use Via F.Ili Cervi 8 27010 Valle Salimbene Italia Germany Togal-Werk AG Ibuprofen Togal Ibuprofen AKUT 400 mg Film-coated tablet Oral use Kardinal-Faulhaber-Str. 5 400mg Filmtabletten 80333 München Germany Germany TUSSIN Pharma GmbH Ibuprofen Ibu-Attritin forte 600 mg Film-coated tablet Oral use Menchestr. 22a 35274 Kirchhain Germany

121

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany TUSSIN Pharma GmbH Ibuprofen Ibu-Attritin N 400 mg Film-coated tablet Oral use Menchestr. 22a 35274 Kirchhain Germany Germany Procter & Gamble Service Ibuprofen WICK DuoGrippal 200 mg Film-coated tablet Oral use GmbH pseudoephedrine 200mg/30 mg 30 mg Zweigniederlassung Wick hydrochloride Filmtabletten Pharma Sulzbacher Str. 40 65824 Schwalbach / Taunus Germany Germany Winthrop Arzneimittel GmbH Ibuprofen Ibuflam 400mg 400 mg Film-coated tablet Oral use Brüningstr. 50 Lichtenstein 65926 Frankfurt am Main Germany Germany Winthrop Arzneimittel GmbH Ibuprofen Ibuflam 600mg 600 mg Film-coated tablet Oral use Brüningstr. 50 Lichtenstein 65926 Frankfurt am Main Germany Germany Winthrop Arzneimittel GmbH Ibuprofen Ibuflam-Lysin 400 mg 400 mg Film-coated tablet Oral use Brüningstr. 50 Filmtabletten 65926 Frankfurt am Main Germany Germany Winthrop Arzneimittel GmbH Ibuprofen Ibuflam 4% 200 mg Oral suspension Oral use Brüningstr. 50 65926 Frankfurt am Main Germany

122

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Winthrop Arzneimittel GmbH Ibuprofen Ibuflam akut 400 mg 400 mg Film-coated tablet Oral use Brüningstr. 50 Filmtabletten 65926 Frankfurt am Main Germany Germany Winthrop Arzneimittel GmbH Ibuprofen Ibuflam 800mg 800 mg Film-coated tablet Oral use Brüningstr. 50 Lichtenstein 65926 Frankfurt am Main Germany Germany Winthrop Arzneimittel GmbH Ibuprofen Ibuflam Kindersaft 2% 100 mg oral suspension oral use Brüningstr. 50 gegen Fieber und 65926 Frankfurt am Main Schmerzen Germany Germany Wörwag Pharma GmbH & Ibuprofen Dignoflex 400 400 mg Film-coated tablet Oral use Co. KG Calwer Str. 7 71034 Böblingen Germany Germany Wörwag Pharma GmbH & Ibuprofen Dignoflex 600 400 mg Film-coated tablet Oral use Co. KG Calwer Str. 7 71034 Böblingen Germany Germany Wörwag Pharma GmbH & Ibuprofen Dignoflex 800 retard 800 mg Prolonged-release Oral use Co. KG tablet Calwer Str. 7 71034 Böblingen Germany

123

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Germany Wörwag Pharma GmbH & Ibuprofen Dignoflex 400mg retard 400 mg Prolonged-release Oral use Co. KG tablet Calwer Str. 7 71034 Böblingen Germany Germany Wrafton Laboratories Ibuprofen Ibuprofen Perrigo 200 200 mg Film-coated tablet Oral use Limited mg Filmtabletten EX33 2DL Wrafton Braunton Devon Great Britain Germany Wrafton Laboratories Ibuprofen Ibuprofen Perrigo 400 400 mg Film-coated tablet Oral use Limited mg Filmtabletten EX33 2DL Wrafton Braunton Devon Great Britain Germany Zambon GmbH Ibuprofen SPIDIFEN 400 mg 400 mg Film-coated tablet Oral use Fraunhoferstr. 18b Filmtabletten 82152 Planegg-Martinsried Germany Greece Abbott Laboratories Ellas Ibuprofen BRUFEN 400 mg Coated tablet Oral use ABEE Agiou Dimitriou 63 174 56 Alimos Greece

124

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Greece Abbott Laboratories Ellas Ibuprofen BRUFEN 800 mg Film-coated tablet Oral use ABEE Agiou Dimitriou 63 174 56 Alimos Greece Greece Abbott Laboratories Ellas Ibuprofen BRUFEN 800 mg Slow-release film- Oral use ABEE coated tablet Agiou Dimitriou 63 174 56 Alimos Greece Greece Abbott Laboratories Ellas Ibuprofen BRUFEN 100 mg/5ml Syrup Oral use ABEE Agiou Dimitriou 63 174 56 Alimos Greece Greece Abbott Laboratories Ellas Ibuprofen BRUFEN 200 mg Coated tablet Oral use ABEE Agiou Dimitriou 63 174 56 Alimos Greece Greece Abbott Laboratories Ellas Ibuprofen BRUFEN 600 mg Film-coated tablet Oral use ABEE Agiou Dimitriou 63 174 56 Alimos Greece

125

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Greece Actavis Group PTC ehf Ibuprofen IBUPROFEN/ACTAVIS 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Greece Actavis Group PTC ehf Ibuprofen IBUPROFEN/ACTAVIS 600 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Greece Actavis Group PTC ehf Ibuprofen IBUPROFEN/ACTAVIS 800 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Greece Actavis Group PTC ehf Ibuprofen IBUPROFEN/ACTAVIS 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Greece Boehringer Ingelheim Ibuprofen MUCOCOLD 200 mg Film-coated tablet Oral use International GmbH pseudoephedrine 30 mg P.O.BOX 200 hydrochloride D-6507 Ingelheim am Rhein Germany Greece Pfizer Ellas Α.Ε. Ibuprofen ADVIL 400 mg Film-coated tablet Oral use Mesogeion 243, 154 51, Neo Psihiko Greece

126

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Greece Pfizer Ellas Α.Ε. Ibuprofen ADVIL 200 mg Capsule, soft Oral use Mesogeion 243, 154 51, Neo Psihiko Greece Greece Pfizer Ellas Α.Ε. Ibuprofen ADVIL 200 mg Coated tablet Oral use Mesogeion 243, 154 51, Neo Psihiko Greece Greece Pfizer Ellas Α.Ε. Ibuprofen ADVIL 400 mg Capsule, soft Oral use Mesogeion 243, 154 51, Neo Psihiko Greece Greece IOUL & EIR TSETI FAR/KA Ibuprofen ALGOFREN 400 mg Effervescent granules Oral use ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece Greece IOUL & EIR TSETI FAR/KA Ibuprofen ALGOFREN 600 mg Effervescent granules Oral use ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

127

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Greece IOUL & EIR TSETI FAR/KA Ibuprofen ALGOFREN 600 mg Film-coated tablet Oral use ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece Greece IOUL & EIR TSETI FAR/KA Ibuprofen ALGOFREN 500 mg Suppository Rectal use ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece Greece IOUL & EIR TSETI FAR/KA Ibuprofen ALGOFREN 400 mg Effervescent tablet Oral use ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece Greece IOUL & EIR TSETI FAR/KA Ibuprofen ALGOFREN 200 mg Effervescent granules Oral use ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

128

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Greece IOUL & EIR TSETI FAR/KA Ibuprofen ALGOFREN 200 mg Effervescent tablet Oral use ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece Greece IOUL & EIR TSETI FAR/KA Ibuprofen ALGOFREN 200 mg Film-coated tablet Oral use ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece Greece Reckitt Benckiser Hellas Ibuprofen NUROFEN (MINT) 200 mg Orodispersible tablet Oral use Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece Greece Reckitt Benckiser Hellas Ibuprofen NUROFEN COLD AND 200 mg Film-coated tablet Oral use Chemical ABEE pseudoephedrine FLU 30 mg Taki Kavalieratou 7 Street hydrochloride 14564 Kato Kifissia Athens Greece

129

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Greece Reckitt Benckiser Hellas Ibuprofen NUROFEN (LEMON) 200 mg Orodispersible tablet Oral use Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece Greece Reckitt Benckiser Hellas Ibuprofen NUROFEN 400 mg Capsule, soft Oral use Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece Greece Reckitt Benckiser Hellas Ibuprofen NUROFEN LIQUID 200 mg Capsule, soft Oral use Chemical ABEE CAPSULES Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece Greece Reckitt Benckiser Hellas Ibuprofen NUROFEN 200 mg Coated tablet Oral use Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

130

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Greece Reckitt Benckiser Hellas Ibuprofen NUROFEN 200 mg Capsule, soft Oral use Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece Greece Reckitt Benckiser Hellas Ibuprofen sodium NUROFEN EXPRESS 256 mg Coated tablet Oral use Chemical ABEE dihydrate Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece Greece Reckitt Benckiser Hellas Ibuprofen sodium NUROFEN EXPRESS 512 mg Coated tablet Oral use Chemical ABEE dihydrate Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece Greece GALENICA A.E. Dexibuprofen SERACTIL 300 mg Film-coated tablet Oral use Eleftherias 4, 14564, Kifissia, Greece Greece GALENICA A.E. Dexibuprofen SERACTIL 400 mg Film-coated tablet Oral use Eleftherias 4, 14564, Kifissia, Greece

131

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Greece Pfizer Ellas Α.Ε. Ibuprofen ADVIL 100mg/5ml Oral suspension Oral use Mesogeion 243, 154 51, Neo Psihiko Greece Greece IOUL & EIR TSETI FAR/KA Ibuprofen ALGOFREN 400 mg Film-coated tablet Oral use ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece Greece IOUL & EIR TSETI FAR/KA Ibuprofen ALGOFREN 100mg/5ml Syrup Oral use ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece Hungary Pfizer Corporation Austria Ibuprofen ADVIL ULTRA FORTE 400 mg Capsule, soft Oral use GmbH lágy kapszula Floridsdorfer Hauptstraße 1 1210 Wien Austria Hungary Pfizer Corporation Austria Ibuprofen ADVIL ULTRA lágy 200 mg Capsule, soft Oral use GmbH kapszula Floridsdorfer Hauptstraße 1 1210 Wien Austria

132

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Hungary sanofi-aventis Zrt. Ibuprofen ALGOFLEX 200 mg 200 mg Film-coated tablet Oral use 1045 Budapest, Tó u. 1-5. filmtabletta Hungary Hungary sanofi-aventis Zrt. Ibuprofen ALGOFLEX 400 mg 400 mg Film-coated tablet Oral use 1045 Budapest, Tó u. 1-5. filmtabletta Hungary Hungary sanofi-aventis Zrt. Ibuprofen ALGOFLEX FORTE 600 mg Film-coated tablet Oral use 1045 Budapest, Tó u. 1-5. filmtabletta Hungary Hungary sanofi-aventis Zrt. Ibuprofen ALGOFLEX Izom+Ízület 300 mg Prolonged-release Oral use 1045 Budapest, Tó u. 1-5. 300 mg retard kemény capsule, hard Hungary kapszula Hungary sanofi-aventis Zrt. Ibuprofen ALGOFLEX NORMA 400 400 mg Film-coated tablet Oral use 1045 Budapest, Tó u. 1-5. mg filmtabletta Hungary Hungary sanofi-aventis Zrt. Ibuprofen ALGOFLEX RAPID 400 400 mg Film-coated tablet Oral use 1045 Budapest, Tó u. 1-5. mg filmtabletta Hungary Hungary sanofi-aventis Zrt. Ibuprofen ALGOFLEX-M tabletta 400 mg Tablet oral use 1045 Budapest, Tó u. 1-5. drotaverine Hungary Hungary Abbott Laboratories Ibuprofen Brufen 400 mg 400 mg Effervescent granules Oral use Magyarország Kft. pezsgőgranulátum 1095 Budapest Lechner Ödön fasor 7 Hungary

133

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Hungary Abbott Laboratories Ibuprofen BRUFEN 800 mg retard 800 mg Prolonged-release Oral use Magyarország Kft. tabletta tablet 1095 Budapest Lechner Ödön fasor 7 Hungary Hungary Abbott Laboratories Ibuprofen BRUFEN cukormentes 40 mg/ml Oral suspension Oral use Magyarország Kft. 40 mg/ml belsőleges 1095 Budapest szuszpenzió Lechner Ödön fasor 7 Hungary Hungary Dolorgiet GmbH & Co. KG Ibuprofen DOLGIT AKUT 400 mg 400 mg Capsule, soft Oral use Otto-von-Guericke-Str. 1 lágy kapszula 53757 Sankt Augustin Germany Hungary Dolorgiet GmbH & Co. KG Ibuprofen DOLGIT MAX 800 mg 800 mg Film-coated tablet Oral use Otto-von-Guericke-Str. 1 filmtabletta 53757 Sankt Augustin Germany Hungary Vitabalans Oy Ibuprofen IBUMAX 200 mg 200 mg Film-coated tablet Oral use Varastokatu 8 filmtabletta 13500 Hämeenlinna Finland Hungary Vitabalans Oy Ibuprofen IBUMAX 400 mg 400 mg Film-coated tablet Oral use Varastokatu 8 filmtabletta 13500 Hämeenlinna Finland

134

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Hungary Vitabalans Oy Ibuprofen IBUMAX 600 mg 600 mg Film-coated tablet Oral use Varastokatu 8 filmtabletta 13500 Hämeenlinna Finland Hungary Vitabalans Oy Ibuprofen IBUMAX 800 mg 800 mg Film-coated tablet Oral use Varastokatu 8 filmtabletta 13500 Hämeenlinna Finland Hungary APC Instytut Sp. z o.o. Ibuprofen IBUPROFEN APC 200 200 mg Film-coated tablet Oral use Grójecka st. 22/24 lok. 4 mg filmtabletta 02-301 Warsaw Poland Hungary APC Instytut Sp. z o.o. Ibuprofen IBUPROFEN APC 400 400 mg Film-coated tablet Oral use Grójecka st. 22/24 lok. 4 mg filmtabletta 02-301 Warsaw Poland Hungary Boehringer Ingelheim Ibuprofen IBUPROFEN 400 mg Capsule, soft Oral use International GmbH BOEHRINGER Binger Straße 173 INGELHEIM 400 mg 55216 Ingelheim am Rhein lágy kapszula Germany

135

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Hungary Galpharm Healthcare Ibuprofen IBUPROFEN GALPHARM 200 mg Film-coated tablet Oral use Limited 200 mg filmtabletta Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom Hungary Galpharm Healthcare Ibuprofen IBUPROFEN GALPHARM 400 mg Film-coated tablet Oral use Limited 400 mg filmtabletta Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom Hungary Pharmaceutical Works Polfa Ibuprofen IBUPROFEN POLFA 200 200 mg Coated tablet Oral use in Pabianice Joint-Stock Co. mg bevont tabletta Marszałka J. Piłsudskiego St. 5 95-200 Pabianice Poland Hungary Rockspring Healthcare Ibuprofen IBUPROFEN 600 mg Effervescent granules Oral use Limited ROCKSPRING 600 mg 38/40 Chamberlayne Road pezsgőgranulátum London NW10 3JE United Kingdom

136

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Hungary ratiopharm GmbH Ibuprofen IBUPROFEN- 200 mg Film-coated tablet Oral use Graf-Arco-Str. 3 RATIOPHARM 200 mg 89079 Ulm filmtabletta Germany Hungary ratiopharm GmbH Ibuprofen IBUPROFEN- 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 RATIOPHARM 400 mg 89079 Ulm filmtabletta Germany Hungary Berlin-Chemie AG Ibuprofen IBUSTAR 400 mg 400 mg Film-coated tablet Oral use Glienicker Weg 125 filmtabletta 12489 Berlin Germany Hungary PANNONPHARMA Ibuprofen MELFEN 200 mg bevont 200 mg Coated tablet Oral use Gyógyszergyártó Kft. tabletta 7720 Pécsvárad Pannonpharma út 1. Hungary Hungary PANNONPHARMA Ibuprofen MELFEN 400 mg bevont 400 mg Coated tablet Oral use Gyógyszergyártó Kft. tabletta 7720 Pécsvárad Pannonpharma út 1. Hungary Hungary Boehringer Ingelheim Ibuprofen MUCOGRIP 200 mg/30 200 mg Film-coated tablet Oral use International GmbH pseudoephedrine mg filmtabletta 30 mg Binger Straße 173 55216 Ingelheim am Rhein Germany

137

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Hungary Reckitt Benckiser Healthcare Ibuprofen NUROFEN 200 mg 200 mg Coated tablet Oral use International Limited bevont tabletta Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Hungary Reckitt Benckiser Healthcare Ibuprofen NUROFEN COLD and 200 mg Film-coated tablet Oral use International Limited pseudoephedrine FLU 200 mg/30 mg 30 mg Bath Road 103-105 filmtabletta Berkshire SL1 3UH Slough United Kingdom Hungary Reckitt Benckiser Healthcare Ibuprofen NUROFEN eperízű 20 20 mg/ml Oral suspension Oral use International Limited mg/ml belsőleges Bath Road 103-105 szuszpenzió Berkshire gyermekeknek SL1 3UH Slough United Kingdom Hungary Reckitt Benckiser Healthcare Ibuprofen NUROFEN FORTE 400 400 mg Coated tablet Oral use International Limited mg bevont tabletta Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

138

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Hungary Reckitt Benckiser Healthcare Ibuprofen NUROFEN NON-AQUA 200 mg Orodispersible tablet Oral use International Limited 200 mg szájban Bath Road 103-105 diszpergálódó tabletta Berkshire SL1 3UH Slough United Kingdom Hungary Reckitt Benckiser Healthcare Ibuprofen NUROFEN RAPID 200 200 mg Capsule, soft Oral use International Limited mg lágy kapszula Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Hungary Reckitt Benckiser Healthcare Ibuprofen NUROFEN RAPID 200 mg Coated tablet Oral use International Limited bevont tabletta Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Hungary Reckitt Benckiser Healthcare Ibuprofen NUROFEN RAPID FORTE 400 mg Capsule, soft Oral use International Limited 400 mg lágy kapszula Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

139

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Hungary Reckitt Benckiser Healthcare Ibuprofen NUROFEN RAPID FORTE 400 mg Powder for oral Oral use International Limited 400 mg por belsőleges solution Bath Road 103-105 oldathoz Berkshire SL1 3UH Slough United Kingdom Hungary Reckitt Benckiser Healthcare Ibuprofen NUROFEN RAPID FORTE 400 mg Coated tablet Oral use International Limited bevont tabletta Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Hungary TEVA Gyógyszergyár zRt. Ibuprofen RAPIDOPHEN 200 mg 200 mg Granules for oral Oral use 4042 Debrecen granulátum belsőleges solution Pallagi út 13. oldathoz Hungary Hungary TEVA Gyógyszergyár zRt. Ibuprofen RAPIDOPHEN 200 mg 200 mg Capsule, soft Oral use 4042 Debrecen lágy kapszula Pallagi út 13. Hungary Hungary TEVA Gyógyszergyár zRt. Ibuprofen RAPIDOPHEN 400 mg 400 mg Granules for oral Oral use 4042 Debrecen granulátum belsőleges solution Pallagi út 13. oldathoz Hungary Hungary TEVA Gyógyszergyár zRt. Ibuprofen RAPIDOPHEN 400 mg 400 mg Capsule, soft Oral use 4042 Debrecen lágy kapszula Pallagi út 13. Hungary

140

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Hungary TEVA Gyógyszergyár zRt. Ibuprofen RAPIDOPHEN 600 mg 600 mg Granules for oral Oral use 4042 Debrecen granulátum belsőleges solution Pallagi út 13. oldathoz Hungary Hungary TEVA Gyógyszergyár zRt. Ibuprofen RAPIDOPHEN BABY 20 20 mg/ml Oral suspension Oral use 4042 Debrecen mg/ml belsőleges Pallagi út 13. szuszpenzió Hungary Hungary sanofi-aventis Zrt. Ibuprofen RHINATHIOL COLD 200 200 mg film-coated tablet oral use 1045 Budapest, Tó u. 1-5. pseudoephedrine mg/30 mg filmtabletta 30 mg Hungary Hungary Zambon S.p.A. Ibuprofen SPEDIFEN 400 mg 400 mg Film-coated tablet Oral use Via Lillo del Duca 10 filmtabletta 20091, Bresso (Mi) Italy Hungary Zambon S.p.A. Ibuprofen SPEDIFEN 400 mg 400 mg Granules Oral use Via Lillo del Duca 10 granulátum 20091, Bresso (Mi) Italy Hungary Zambon S.p.A. Ibuprofen SPEDIFEN 600 mg 600 mg Granules Oral use Via Lillo del Duca 10 granulátum 20091, Bresso (Mi) Italy Hungary Gebro Pharma GmbH Dexibuprofen Seractil 400 mg 400 mg Film-coated tablet Oral use 13 Bahnhofbichl filmtabletta 6391 Fieberbrunn Austria

141

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Hungary Gebro Pharma GmbH Dexibuprofen Seractil Dolo 200 mg 200 mg Film-coated tablet Oral use 13 Bahnhofbichl filmtabletta 6391 Fieberbrunn Austria Hungary Gebro Pharma GmbH Dexibuprofen Seractil Dolo 300 mg 300 mg Film-coated tablet Oral use 13 Bahnhofbichl filmtabletta 6391 Fieberbrunn Austria Iceland Alvogen IPCo S.àr.l. Ibuprofen Alvofen Express 200 mg Capsule, soft Oral use Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg Iceland Alvogen IPCo S.àr.l. Ibuprofen Alvofen Express 400 mg Capsule, soft Oral use Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg Iceland Bristol Laboratories Limited, Ibuprofen Ibuprofen Bril 200 mg Film-coated tablet Oral use Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom Iceland Bristol Laboratories Limited, Ibuprofen Ibuprofen Bril 400 mg Film-coated tablet Oral use Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

142

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Iceland Bristol Laboratories Limited, Ibuprofen Ibuprofen Bril 600 mg Film-coated tablet Oral use Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom Iceland ratiopharm Oy Ibuprofen Ibuxin 200 mg Film-coated tablet Oral use Keilaranta 10 02150 Espoo Finland Iceland ratiopharm Oy Ibuprofen Ibuxin 400 mg Film-coated tablet Oral use Keilaranta 10 02150 Espoo Finland Iceland ratiopharm Oy Ibuprofen Ibuxin 600 mg Film-coated tablet Oral use Keilaranta 10 02150 Espoo Finland Iceland ratiopharm Oy Ibuprofen Ibuxin 800 mg Film-coated tablet Oral use Keilaranta 10 02150 Espoo Finland Iceland ratiopharm GmbH Ibuprofen ibuxin rapid 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany

143

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Iceland Actavis Group PTC ehf Ibuprofen Íbúfen 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Iceland Actavis Group PTC ehf Ibuprofen Íbúfen 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Iceland Actavis Group PTC ehf Ibuprofen Íbúfen 600 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Iceland Actavis Group PTC ehf Ibuprofen Íbúfen 800 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Iceland Portfarma ehf. Ibuprofen Íbúprófen Portfarma 400 mg Film-coated tablet Oral use Borgartúni 26 105 Reykjavík Iceland Ireland GlaxoSmithKline Consumer Ibuprofen Actiprofen 200mg 200 mg Film-coated tablet Oral use Healthcare (Ireland) Limited Tablets Stonemasons Way Rathfarnham Dublin 16 Ireland

144

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Ireland Pfizer Healthcare Ireland Ibuprofen Advil 200mg Tablets 200 mg Coated tablet Oral use 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland Ireland Pfizer Healthcare Ireland Ibuprofen Advil Cold and Flu 200 mg Coated tablet Oral use 9 Riverwalk pseudoephedrine Coated Tablets 30 mg National Digital Park hydrochloride Citywest Business Campus Dublin 24 Ireland Ireland Pfizer Healthcare Ireland Ibuprofen Advil Liquigels, 200mg 200 mg Capsule, soft Oral use 9 Riverwalk Capsules National Digital Park Citywest Business Campus Dublin 24 Ireland Ireland GlaxoSmithKline Consumer Ibuprofen Apfen Plus 200mg / 200 mg Film-coated tablet Oral use Healthcare (Ireland) Limited codeine phosphate 12.8mg Film-Coated 12.8 mg Stonemasons Way hemihydrate Tablets Rathfarnham Dublin 16 Ireland

145

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Ireland BGP Products Ireland Ibuprofen Brufen 400mg film- 400 mg Film-coated tablet Oral use Limited coated tablets Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland Ireland BGP Products Ireland Ibuprofen Brufen 600mg film- 600 mg Film-coated tablet Oral use Limited coated tablets Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland Ireland BGP Products Ireland Ibuprofen Brufen 400mg 400 mg Effervescent granules Oral use Limited Effervescent Granules Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland Ireland BGP Products Ireland Ibuprofen Brufen Paediatric 100 20 mg/ml Oral suspension Oral use Limited mg / 5 ml Oral Kingswood Drive 4051 Suspension. Citywest Business Campus Dublin 24 Ireland

146

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Ireland BGP Products Ireland Ibuprofen Brufen Retard 800mg 800 mg Prolonged-release Oral use Limited Prolonged Release tablet Kingswood Drive 4051 Tablets Citywest Business Campus Dublin 24 Ireland Ireland Actavis Group PTC ehf Ibuprofen Buplex 200mg film- 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 coated tablets 220 Hafnarfjörður Iceland Ireland Actavis Group PTC ehf Ibuprofen Buplex 400mg film- 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 coated tablets 220 Hafnarfjörður Iceland Ireland Actavis Group PTC ehf Ibuprofen Buplex Rx 200 mg film- 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 coated tablets 220 Hafnarfjörður Iceland Ireland Actavis Group PTC ehf Ibuprofen Buplex Rx 400 mg film- 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 coated tablets 220 Hafnarfjörður Iceland Ireland Actavis Group PTC ehf Ibuprofen Buplex Rx 600 mg film- 600 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 coated tablets 220 Hafnarfjörður Iceland

147

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Ireland Clonmel Healthcare Ltd. Ibuprofen Easofen 200mg Film- 200 mg Film-coated tablet Oral use Waterford Road, Coated Tablets. Co. Tipperary Ireland Ireland Clonmel Healthcare Ltd. Ibuprofen Easofen Max Strength 400 mg Film-coated tablet Oral use Waterford Road, 400 mg Film-coated Co. Tipperary Tablets Ireland Ireland Pinewood Laboratories Ibuprofen Fenopine 200 mg Film- 200 mg Film-coated tablet Oral use Limited coated Tablets. Ballymacarbry, Clonmel Co Tipperary Ireland Ireland Pinewood Laboratories Ibuprofen Fenopine 400 mg Film- 400 mg Film-coated tablet Oral use Limited coated Tablets. Ballymacarbry, Clonmel Co Tipperary Ireland Ireland Pinewood Laboratories Ibuprofen Fenopine 600 mg Film- 600 mg Film-coated tablet Oral use Limited Coated Tablets. Ballymacarbry, Clonmel Co Tipperary Ireland

148

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Ireland BGP Products Ireland Ibuprofen Brufen 200mg 200 mg Effervescent granules Oral use Limited Effervescent Granules Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland Ireland McDermott Laboratories Ltd Ibuprofen Ibuprofen 200mg film- 200 mg Film-coated tablet Oral use t/a Gerard Laboratories coated tablets 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Ireland McDermott Laboratories Ltd Ibuprofen Ibuprofen 400mg film- 400 mg Film-coated tablet Oral use t/a Gerard Laboratories coated tablets 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland Ireland BGP Products Ireland Ibuprofen Brufen 600mg 600 mg Effervescent granules Oral use Limited Effervescent Granules Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

149

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Ireland The Boots Company PLC Ibuprofen Ibuprofen and Codeine 200 mg Film-coated tablet Oral use 1 Thane Road West codeine phosphate 200 mg/ 12.8 mg film- 12.8 mg Nottingham hemihydrate coated Tablets NG2 3AA United Kingdom Ireland Galpharm Healthcare Ibuprofen Ibuprofen Galpharm 200 mg Film-coated tablet Oral use Limited 200mg Film-coated Hugh House Tablets Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom Ireland Galpharm Healthcare Ibuprofen Ibuprofen Galpharm 400 mg Film-coated tablet Oral use Limited Max 400mg Film-coated Hugh House Tablets Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom Ireland Clonmel Healthcare Ltd. Ibuprofen Melfen 200mg Film- 200 mg Film-coated tablet Oral use Waterford Road, coated tablets Co. Tipperary Ireland

150

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Ireland Clonmel Healthcare Ltd. Ibuprofen Melfen 400mg Film- 400 mg Film-coated tablet Oral use Waterford Road, coated tablets Co. Tipperary Ireland Ireland Reckitt Benckiser Ireland Ibuprofen Nurofen 200 mg Coated 200 mg Coated Tablet Oral use Ltd. Tablets 7 Riverwalk Citywest Business Campus Dublin 24 Ireland Ireland Reckitt Benckiser Ireland Ibuprofen Nurofen 200mg 200 mg Effervescent tablet Oral use Ltd. Effervescent Tablets 7 Riverwalk Citywest Business Campus Dublin 24 Ireland Ireland Crookes Healthcare Ltd., Ibuprofen Nurofen Advance 200 200 mg Film-coated tablet Oral use Thane Road West 1 mg Tablets. Nottingham NG2 3AA United Kingdom Ireland Reckitt Benckiser Ireland Ibuprofen Nurofen Advance 400 mg Powder for oral Oral use Ltd. Maximum Strength solution 7 Riverwalk 400mg oral powder Citywest Business Campus Dublin 24 Ireland

151

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Ireland Reckitt Benckiser Ireland Ibuprofen Nurofen Cold & Flu 200 mg Film-coated tablet Oral use Ltd. pseudoephedrine Film-coated Tablets 30 mg 7 Riverwalk hydrochloride Citywest Business Campus Dublin 24 Ireland Ireland Reckitt Benckiser Ireland Ibuprofen Nurofen Express 200 200 mg Coated tablet Oral use Ltd. mg Tablets 7 Riverwalk Citywest Business Campus Dublin 24 Ireland Ireland Reckitt Benckiser Ireland Ibuprofen Nurofen Express 400 mg Coated tablet Oral use Ltd. Maximum Strength 400 7 Riverwalk mg Tablets Citywest Business Campus Dublin 24 Ireland Ireland Reckitt Benckiser Ireland Ibuprofen Nurofen 200mg Liquid 200 mg Capsule, soft Oral use Ltd. Capsules 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

152

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Ireland Reckitt Benckiser Ireland Ibuprofen Nurofen 400mg Liquid 400 mg Capsule, soft Oral use Ltd. Capsules 7 Riverwalk Citywest Business Campus Dublin 24 Ireland Ireland Reckitt Benckiser Ireland Ibuprofen Nurofen Long Lasting 300 mg Prolonged-release Oral use Ltd. 300 mg Prolonged capsule, hard 7 Riverwalk Release Hard Capsules Citywest Business Campus Dublin 24 Ireland Ireland Reckitt Benckiser Ireland Ibuprofen Nurofen Plus Tablets 200 mg Film-coated tablet Oral use Ltd. codeine phosphate 12.8 mg 7 Riverwalk hemihydrate Citywest Business Campus Dublin 24 Ireland Ireland Pfizer Healthcare Ireland Ibuprofen Seclodin 400mg Tablets 400 mg Tablet Oral use 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

153

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Ireland Pfizer Healthcare Ireland Ibuprofen Seclodin 400mg Soft 400 mg Capsule, soft Oral use 9 Riverwalk Capsules National Digital Park Citywest Business Campus Dublin 24 Ireland Italy BGP PRODUCTS S.R.L. Ibuprofen BRUFEN 600 mg Effervescent granules Oral use VIALE GIORGIO RIBOTTA 11 00144 ROMA Italy Italy BGP PRODUCTS S.R.L. Ibuprofen BRUFEN 800 mg Film-coated Oral use VIALE GIORGIO RIBOTTA 11 prolonged-release 00144 ROMA tablet Italy Italy BGP PRODUCTS S.R.L. Ibuprofen BRUFEN 400 mg Film-coated tablet Oral use VIALE GIORGIO RIBOTTA 11 00144 ROMA Italy Italy BGP PRODUCTS S.R.L. Ibuprofen BRUFEN 600 mg Film-coated tablet Oral use VIALE GIORGIO RIBOTTA 11 00144 ROMA Italy

154

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy LABORATORIO Ibuprofen ALGOFEN 200 mg Film-coated tablet Oral use FARMACEUTICO SIT SPECIALITA' IGIENICO TERAPEUTICHE S.R.L., Via Cavour 70 27035 Mede - Pavia Italy Italy Reckitt Benckiser Healthcare Ibuprofen NUROFEN 200 mg Film-coated tablet Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Italy Reckitt Benckiser Healthcare Ibuprofen NUROFEN 400 mg Film-coated tablet Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Italy SANDOZ S.P.A. Ibuprofen IBUPROFENE SANDOZ 200 mg Film-coated tablet Oral use Largo U. Boccioni 1 21040 Origgio (VA) - Italy

155

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy Aziende Chimiche Riunite Ibuprofen MOMENT 200 mg Film-coated tablet Oral use Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy Italy Aziende Chimiche Riunite Ibuprofen MOMENT 200 mg/ml Oral drops, solution Oral use Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy Italy Aziende Chimiche Riunite Ibuprofen MOMENT 200 mg Granules for oral Oral use Angelini Francesco solution A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy Italy Aziende Chimiche Riunite Ibuprofen MOMENT 200 mg Effervescent tablet Oral use Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

156

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy Aziende Chimiche Riunite Ibuprofen MOMENT 200 mg Chewable tablet Oral use Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy Italy Aziende Chimiche Riunite Ibuprofen MOMENT 200 mg Capsule, soft Oral use Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy Italy JOHNSON & JOHNSON Ibuprofen ANTALGIL 200 mg Tablet Oral use S.P.A., Via Ardeatina Km 23,500 00040 Santa Palomba - Pomezia (RM) - Italy Italy SPA ITALIANA LABORATORI Ibuprofen CALMINE 200 mg Film-coated tablet Oral use BOUTY Via Vanvitelli, 4 20129 Milano Italy Italy Zambon Italia S.R.L. Ibuprofen SPIDIDOL ANALGESICO 200 mg Effervescent tablet Oral use Via Lillo del Duca 10 20091, Bresso (Mi) Italy

157

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy Zambon Italia S.R.L. Ibuprofen SPIDIDOL ANALGESICO 200 mg Granules for oral Oral use Via Lillo del Duca 10 solution 20091, Bresso (Mi) Italy Italy Zambon Italia S.R.L. Ibuprofen SPIDIDOL ANALGESICO 200 mg/ml Oral drops, solution Oral use Via Lillo del Duca 10 20091, Bresso (Mi) Italy Italy Zambon Italia S.R.L. Ibuprofen SPIDIDOL ANALGESICO 200 mg tablet Oral use Via Lillo del Duca 10 20091, Bresso (Mi) Italy Italy Zambon Italia S.R.L. Ibuprofen SPIDIDOL 400 mg film-coated tablet Oral use Via Lillo del Duca 10 20091, Bresso (Mi) Italy Italy Zambon Italia S.R.L. Ibuprofen SPIDIDOL 400 mg granules for oral Oral use Via Lillo del Duca 10 solution 20091, Bresso (Mi) Italy Italy Zambon Italia S.R.L. Ibuprofen SPIDIFEN 400 mg film-coated tablet Oral use Via Lillo del Duca 10 20091, Bresso (Mi) Italy Italy Zambon Italia S.R.L. Ibuprofen SPIDIFEN 400 mg granules for oral Oral use Via Lillo del Duca 10 solution 20091, Bresso (Mi) Italy

158

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy Zambon Italia S.R.L. Ibuprofen SPIDIFEN 600 mg granules for oral Oral use Via Lillo del Duca 10 solution 20091, Bresso (Mi) Italy Italy Boehringer Ingelheim Italia Ibuprofen BUSCOFEN 200 mg Film-coated tablet Oral use S.P.A. Via Lorenzini, 8 20139 Milano Italy Italy Boehringer Ingelheim Italia Ibuprofen BUSCOFEN 200 mg Capsule, soft Oral use S.P.A. Via Lorenzini, 8 20139 Milano Italy Italy Boehringer Ingelheim Italia Ibuprofen BUSCOFEN 200 mg Granules for oral Oral use S.P.A. solution Via Lorenzini, 8 20139 Milano Italy Italy Novartis Consumer Health Ibuprofen CIBALGINA DUE FAST 200 mg Gastro-resistant tablet Oral use S.P.A., Largo Umberto Boccioni 1 21040 Origgio (VA) Italy Italy Bracco S.P.A. Ibuprofen DOLOFAST 200 mg Tablet Oral use Via Egidio Folli 50 20134 Milano Italy

159

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy Bracco S.P.A. Ibuprofen DOLOFAST 200 mg/ml Oral drops, solution Oral use Via Egidio Folli 50 20134 Milano Italy Italy Angenerico S.P.A. Ibuprofen IBUPROFENE 200 mg Film-coated tablet Oral use Via Nocera Umbra 75 ANGENERICO Roma Italy Italy Angenerico S.P.A. Ibuprofen IBUPROFENE 200 mg/ml Oral drops, solution Oral use Via Nocera Umbra 75 ANGENERICO Roma Italy Italy FARMAKOPEA S.P.A. Ibuprofen SUBITENE 200 mg Effervescent tablet Oral use Via Cavriana 14 Milano Italy Italy FARMAKOPEA S.P.A. Ibuprofen SUBITENE 200 mg Granules for oral Oral use Via Cavriana 14 solution Milano Italy Italy FARMAKOPEA S.P.A. Ibuprofen SUBITENE 400 mg Granules for oral Oral use Via Cavriana 14 solution Milano Italy Italy FARMAKOPEA S.P.A. Ibuprofen SUBITENE 200 mg Film-coated tablet Oral use Via Cavriana 14 Milano Italy

160

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy Aziende Chimiche Riunite Ibuprofen MOMENTACT 400 mg Film-coated tablet Oral use Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy Italy Aziende Chimiche Riunite Ibuprofen MOMENTACT 400 mg Capsule, soft Oral use Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy Italy Aziende Chimiche Riunite Ibuprofen MOMENTACT 400 mg Granules for oral Oral use Angelini Francesco ANALGESICO solution A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy Italy Reckitt Benckiser Healthcare Ibuprofen NUROSOLV 200 mg Orodispersible tablet Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Italy LABORATORI ALTER S.R.L. Ibuprofen IBUPROFENE ALTER 400 mg Film-coated tablet Oral use Via Egadi 7 20144 Milano Italy

161

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy LABORATORI ALTER S.R.L. Ibuprofen IBUPROFENE ALTER 600 mg Film-coated tablet Oral use Via Egadi 7 20144 Milano Italy Italy Reckitt Benckiser Healthcare Ibuprofen NUROFENELLE 200 mg Film-coated tablet Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Italy Reckitt Benckiser Healthcare Ibuprofen NUROFENELLE 400 mg Film-coated tablet Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Italy ABC Farmaceutici S.P.A. Ibuprofen KENDO 200 mg/ml Oral drops, solution Oral use Corso Vittorio Emanuele II 72 10121 Torino Italy Italy RATIOPHARM ITALIA S.R.L. Ibuprofen IBUPROFENE 400 mg Film-coated tablet Oral use Viale Monza 270 RATIOPHARM ITALIA 20128 Milano Italy

162

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy ratiopharm GmbH Ibuprofen IBUPROFENE 200 mg Film-coated tablet Oral use Graf-Arco-Str. 3 RATIOPHARM 89079 Ulm Germany Italy Aziende Chimiche Riunite Ibuprofen MOMENFLOGO 600 mg Granules for oral Oral use Angelini Francesco solution A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy Italy Actavis Group PTC ehf Ibuprofen ZORENDOL 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Italy Actavis Group PTC ehf Ibuprofen ZORENDOL 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Italy Actavis Group PTC ehf Ibuprofen IBUPROFENE ACTAVIS 600 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Italy E-PHARMA TRENTO S.P.A. Ibuprofen IBUPROFENE E- 400 mg Granules for oral Oral use Via Provina, 2 PHARMA TRENTO solution 38123 Frazione Ravina - Trento Italy

163

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy Boots Pharmaceuticals Ibuprofen DOLIPRO 200 mg Film-coated tablet Oral use S.R.L. Via Cesarea 11/10 16121 Genova Italy Italy Boots Pharmaceuticals Ibuprofen DOLIPRO 400 mg Film-coated tablet Oral use S.R.L. Via Cesarea 11/10 16121 Genova Italy Italy Aziende Chimiche Riunite Ibuprofen IBUPROFENE ANGELINI 600 mg Granules for oral Oral use Angelini Francesco solution A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy Italy LABORATORI ALTER S.R.L. Ibuprofen SAKITOL 400 mg Film-coated tablet Oral use Via Egadi 7 20144 Milano Italy Italy DOC GENERICI SRL Ibuprofen IBUPROFENE DOC 600 mg Effervescent granules Oral use Via Turati, 40 GENERICI 20121 Milano Italy

164

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy Boehringer Ingelheim Ibuprofen BUSCOFENACT 400 mg Capsule, soft Oral use International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany Italy Reckitt Benckiser Healthcare Ibuprofen NUROFENCAPS 400 mg Capsule, soft Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Italy DOC GENERICI SRL Ibuprofen IBUPROFEN DOC 20 mg/ml Oral suspension Oral use Via Turati, 40 GENERICS 20121 Milano Italy Italy POLIFARMA BENESSERE Ibuprofen VIAMAL FEBBRE E 200 mg Film-coated tablet Oral use S.R.L. DOLORE Via Laurentine, 289 00142 Roma Italy Italy POLIFARMA BENESSERE Ibuprofen VIAMAL FEBBRE E 400 mg Film-coated tablet Oral use S.R.L. DOLORE Via Laurentine, 289 00142 Roma Italy

165

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy THERABEL GIENNE PHARMA Dexibuprofen SERACTIL 200 mg Film-coated tablet Oral use S.P.A. Via Roberto Koch 1/2 20152 Milano Italy Italy THERABEL GIENNE PHARMA Dexibuprofen SERACTIL 300 mg Film-coated tablet Oral use S.P.A. Via Roberto Koch 1/2 20152 Milano Italy Italy THERABEL GIENNE PHARMA Dexibuprofen SERACTIL 400 mg Film-coated tablet Oral use S.P.A. Via Roberto Koch 1/2 20152 Milano Italy Italy THERABEL GIENNE PHARMA Dexibuprofen SERACTIL 300 mg Powder for oral Oral use S.P.A. suspension Via Roberto Koch 1/2 20152 Milano Italy Italy THERABEL GIENNE PHARMA Dexibuprofen SERACTIL 400 mg Powder for oral Oral use S.P.A. suspension Via Roberto Koch 1/2 20152 Milano Italy

166

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy Bruno Farmaceutici S.p.A. Dexibuprofen FENEXTRA 400 mg Film-coated tablet Oral use Via delle Ande, 15 00144 Roma Italy Italy Bruno Farmaceutici S.p.A. Dexibuprofen FENEXTRA 300 mg Granules for oral Oral use Via delle Ande, 15 suspension 00144 Roma Italy Italy Bruno Farmaceutici S.p.A. Dexibuprofen FENEXTRA 400 mg Granules for oral Oral use Via delle Ande, 15 suspension 00144 Roma Italy Italy Boehringer Ingelheim Ibuprofen IBUPROFENE E 200 mg Film-coated tablet Oral use International GmbH pseudoephedrine PSEUDOEFEDRINA 30 mg Binger Straße 173 BOEHRINGER 55216 Ingelheim am Rhein INGELHEIM Germany Italy Laboratorio Italiano Ibuprofen lysine ARFEN 500 mg Tablet Oral use Biochimico Farmaceutico Lisapharma S.P.A. Via Licinio 11 22036 Erba Como Italy

167

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Italy Laboratorio Italiano Ibuprofen lysine ARFEN 400 mg/3ml Solution for injection Parenteral use Biochimico Farmaceutico Lisapharma S.P.A. Via Licinio 11 22036 Erba Como Italy Italy Carlo Erba O.T.C. S.R.L. Ibuprofen lysine IBUPROFENE CARLO 200 mg Film-coated tablet Oral use Via Ardeatina Km 23 ERBA 500 - Frazione LOC. Santa Palomba 00040 Pomezia Italy Italy Carlo Erba O.T.C. S.R.L. Ibuprofen lysine IBUPROFENE CARLO 400 mg Film-coated tablet Oral use Via Ardeatina Km 23 ERBA 500 - Frazione LOC. Santa Palomba 00040 Pomezia Italy Italy Reckitt Benckiser Healthcare Ibuprofen lysine NUROFENIMMEDIA 200 mg Film-coated tablet Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

168

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Latvia CIPLA (UK) LIMITED Ibuprofen Ibugesic 400 mg film- 400 mg Film-coated tablet Oral use The Old Post House coated tablets Heath Road, Surrey Weybridge KT13 8TS United Kingdom Latvia CIPLA (UK) LIMITED Ibuprofen Ibugesic 600 mg film- 600 mg Film-coated tablet Oral use The Old Post House coated tablets Heath Road, Surrey Weybridge KT13 8TS United Kingdom Latvia Lannacher Heilmittel GmbH Ibuprofen Ibuprofen Lannacher 600 mg Film-coated tablet Oral use Schlossplatz 1 600 mg film-coated A-8502 Lannach tablets Austria Latvia Lannacher Heilmittel GmbH Ibuprofen Ibuprofen Lannacher 400 mg Film-coated tablet Oral use Schlossplatz 1 400 mg film-coated A-8502 Lannach tablets Austria Latvia Abbott Laboratories Baltics Ibuprofen Brufen Plus 400 mg/30 400 mg Film-coated tablet Oral use SIA codeine phosphate mg film-coated tablets 30 mg Mukusalas 101 hemihydrate Riga LV 1004 Latvia Latvia Abbott Laboratories Baltics Ibuprofen Brufen 200 mg 200 mg Effervescent granules Oral use SIA effervescent granules Mukusalas 101 Riga LV 1004 Latvia

169

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Latvia Abbott Laboratories Baltics Ibuprofen Brufen 600 mg 600 mg Effervescent granules Oral use SIA effervescent granules Mukusalas 101 Riga LV 1004 Latvia Latvia Reckitt Benckiser (Poland) Ibuprofen Nurofen Forte Express 400 mg Coated tablet Oral use S.A. 400 mg coated tablets ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Latvia Reckitt Benckiser (Poland) Ibuprofen Nurofen Express 200 200 mg Coated tablet Oral use S.A. mg coated tablets ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Latvia Reckitt Benckiser (Poland) Ibuprofen Nurofen Forte 400 mg 400 mg Coated tablet Oral use S.A. coated tablets ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

170

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Latvia Reckitt Benckiser (Poland) Ibuprofen Nurofen 200 mg film- 200 mg Film-coated tablet Oral use S.A. coated tablets ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Latvia Reckitt Benckiser (Poland) Ibuprofen Nurofen Antigrip 200 200 mg Coated tablet Oral use S.A. pseudoephedrine mg/30 mg coated 30 mg ul. Okunin 1 hydrochloride tablets 05-100 Nowy Dwor Mazowiecki Poland Latvia STIROLBIOFARM BALTIKUM Ibuprofen Ibuprofen Stirol 300 mg 300 mg Capsule, hard Oral use SIA, capsules Rasas 5 Riga Latvia Latvia AS Grindeks Ibuprofen Ibuprofen - Grindeks 400 mg Film-coated tablet Oral use Krustpils 53 400 mg film-coated LV-1057 Riga tablets Latvia Latvia AS Grindeks Ibuprofen Ibuprofen - Grindeks 200 mg Film-coated tablet Oral use Krustpils 53 200 mg film-coated LV-1057 Riga tablets Latvia

171

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Latvia AS “Olainfarm” Ibuprofen Ibuprofen Olainfarm 400 mg Film-coated tablet Oral use Rupnicu iela 5 400 mg film-coated Olaine LV-2114 tablets Latvia Latvia AS “Olainfarm” Ibuprofen Ibulain 200 mg film- 200 mg Film-coated tablet Oral use Rupnicu iela 5 coated tablets Olaine LV-2114 Latvia Latvia Berlin-Chemie AG Ibuprofen Ibustar 400 mg film- 400 mg Film-coated tablet Oral use Glienicker Weg 125 coated tablets 12489 Berlin Germany Latvia STADA Arzneimittel AG Ibuprofen Ibudolor 200 mg coated 200 mg Coated tablet Oral use Stadastr. 2-18 tablets 61118 Bad Vilbel Germany Latvia CTO LT UAB Ibuprofen Ibufanti 100 mg/5 ml 20 mg/ml Oral suspension Oral use S.Daukanto g. 4 oral suspension Siauliu, Siauliu m., Siauliu m.sav., Lithuania LT-77171 Latvia ratiopharm GmbH Ibuprofen Ibuprofen-ratiopharm 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 400 mg film-coated 89079 Ulm tablets Germany

172

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Latvia ratiopharm GmbH Ibuprofen Butifen 400 mg film- 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 coated tablets 89079 Ulm Germany Latvia Abbott Laboratories Baltics Ibuprofen Brufen 400 mg 400 mg Effervescent granules Oral use SIA effervescent granules Mukusalas 101 Riga LV 1004 Latvia Latvia Abbott Laboratories Baltics Ibuprofen Brufen 200 mg film- 200 mg Film-coated tablet Oral use SIA coated tablets Mukusalas 101 Riga LV 1004 Latvia Latvia Abbott Laboratories Baltics Ibuprofen Brufen 20 mg/ml oral 20 mg/ml Oral suspension Oral use SIA suspension Mukusalas 101 Riga LV 1004 Latvia Latvia Abbott Laboratories Baltics Ibuprofen Brufen 800 mg 800 mg Prolonged-release Oral use SIA prolonged-release tablet Mukusalas 101 tablets Riga LV 1004 Latvia

173

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Latvia Abbott Laboratories Baltics Ibuprofen Brufen 400 mg film- 400 mg Film-coated tablet Oral use SIA coated tablets Mukusalas 101 Riga LV 1004 Latvia Latvia UAB “INTELI GENERICS Ibuprofen Ibuprofen Inteli 100 20 mg/ml Oral suspension Oral use NORD”, Seimyniskiu g. 3 mg/5 ml oral Vilnius, LT-09312 suspension Lithuania Latvia Zentiva, k.s. Ibuprofen Ibuprofen Zentiva 400 400 mg Film-coated tablet Oral use U kabelovny 130 mg film-coated tablets 102 37 Praha 10 Dolní Měcholupy Czech Republic Latvia Zentiva, k.s. Ibuprofen Ibuprofen Zentiva 200 200 mg Film-coated tablet Oral use U kabelovny 130 mg film-coated tablets 102 37 Praha 10 Dolní Měcholupy Czech Republic Latvia Takeda Pharma AS Ibuprofen Ibumetin 200 mg film- 200 mg Film-coated tablet Oral use Jaama 55B coated tablets Polva 63308 Estonia Latvia Takeda Pharma AS Ibuprofen Ibumetin 400 mg film- 400 mg Film-coated tablet Oral use Jaama 55B coated tablets Polva 63308 Estonia

174

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Latvia Zentiva, k.s. Ibuprofen Ibalgin Fast 400 mg 400 mg Film-coated tablet Oral use U kabelovny 130 film-coated tablets 102 37 Praha 10 Dolní Měcholupy Czech Republic Latvia Vitabalans Oy Ibuprofen Ibumax 200 mg film- 200 mg Film-coated tablet Oral use Varastokatu 8 coated tablets 13500 Hämeenlinna Finland Latvia Vitabalans Oy Ibuprofen Ibumax 400 mg film- 400 mg Film-coated tablet Oral use Varastokatu 8 coated tablets 13500 Hämeenlinna Finland Latvia Vitabalans Oy Ibuprofen Ibumax 600 mg film- 600 mg Film-coated tablet Oral use Varastokatu 8 coated tablets 13500 Hämeenlinna Finland Lithuania BGP Products SIA, Ibuprofen Abfen 40 mg/ml Oral suspension Oral use Mukusalas 101 Riga LV 1004 Latvia Lithuania BGP Products SIA, Ibuprofen Brufen 200 mg Film-coated tablet Oral use Mukusalas 101 Riga LV 1004 Latvia

175

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Lithuania BGP Products SIA, Ibuprofen Brufen 400 mg Film-coated tablet Oral use Mukusalas 101 Riga LV 1004 Latvia Lithuania BGP Products SIA, Ibuprofen Brufen 800 mg Prolonged-release Oral use Mukusalas 101 tablet Riga LV 1004 Latvia Lithuania BGP Products SIA, Ibuprofen Brufen 400 mg Effervescent granules Oral use Mukusalas 101 Riga LV 1004 Latvia Lithuania BGP Products SIA, Ibuprofen Brufen 20 mg/ml Oral suspension Oral use Mukusalas 101 Riga LV 1004 Latvia Lithuania ratiopharm GmbH Ibuprofen Butifen 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Lithuania STADA Arzneimittel AG Ibuprofen IBUDOLOR 200 mg Film-coated tablet Oral use Stadastr. 2-18 61118 Bad Vilbel Germany Lithuania Vitabalans Oy Ibuprofen IBUMAX 200 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland

176

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Lithuania Vitabalans Oy Ibuprofen IBUMAX 400 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Lithuania Vitabalans Oy Ibuprofen IBUMAX 600 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Lithuania Pabianickie Zakłady Ibuprofen IBUPROFEN Polfa 200 mg Coated tablet Oral use Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland Lithuania AS Grindeks Ibuprofen IBUPROFEN-GRINDEKS 200 mg Film-coated tablet Oral use Krustpils 53 LV-1057 Riga Latvia Lithuania US Pharmacia Sp. z o.o. Ibuprofen IBUPROM 200 mg Coated tablet Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd Lithuania US Pharmacia Sp. z o.o. Ibuprofen IBUPROM 400 mg Film-coated tablet Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd

177

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Lithuania Zentiva, k.s. Ibuprofen Ibalgin Fast 400 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Lithuania Takeda Pharma AS Ibuprofen Ibumetin 200 mg Film-coated tablet Oral use Jaama 55B Polva 63308 Estonia Lithuania Takeda Pharma AS Ibuprofen Ibumetin 400 mg Film-coated tablet Oral use Jaama 55B Polva 63308 Estonia Lithuania Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Lithuania Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Lithuania Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 600 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

178

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Lithuania Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 800 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Lithuania Lannacher Heilmittel GmbH Ibuprofen Ibuprofen Lannacher 400 mg Film-coated tablet Oral use Schlossplatz 1 A-8502 Lannach Austria Lithuania Lannacher Heilmittel GmbH Ibuprofen Ibuprofen Lannacher 600 mg Film-coated tablet Oral use Schlossplatz 1 A-8502 Lannach Austria Lithuania BGP Products SIA, Ibuprofen Brufen 200 mg Effervescent granules Oral use Mukusalas 101 Riga LV 1004 Latvia Lithuania BGP Products SIA, Ibuprofen Brufen 600 mg Effervescent granules Oral use Mukusalas 101 Riga LV 1004 Latvia Lithuania Zentiva, k.s. Ibuprofen Ibuprofen Zentiva 200 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

179

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Lithuania Zentiva, k.s. Ibuprofen Ibuprofen Zentiva 400 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Lithuania US Pharmacia Sp. z o.o. Ibuprofen Ibuprom Express 400 mg Capsule, soft Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd Lithuania Berlin-Chemie AG Ibuprofen Ibustar 400 mg Film-coated tablet Oral use Glienicker Weg 125 12489 Berlin Germany Lithuania Actavis Group PTC ehf Ibuprofen Ifenin 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Lithuania Actavis Group PTC ehf Ibuprofen Ifenin 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Lithuania Reckitt Benckiser (Poland) Ibuprofen NUROFEN 200 mg Coated tablet Oral use S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

180

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Lithuania Reckitt Benckiser (Poland) Ibuprofen NUROFEN EXPRESS 200 mg Coated tablet Oral use S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Lithuania Reckitt Benckiser (Poland) Ibuprofen NUROFEN FORTE 400 mg Coated tablet Oral use S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Lithuania Reckitt Benckiser (Poland) Ibuprofen NUROFEN FORTE 400 mg Coated tablet Oral use S.A. EXPRESS ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Lithuania UAB Corpus Medica Ibuprofen TVINGESTIN 400 mg Film-coated tablet Oral use Sukilėlių pr. 61 LT-49333 Kaunas Lithuania Luxembourg Pfizer bv Ibuprofen Advil Mono Liquid Caps 200 mg Effervescent tablet Oral use Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

181

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Luxembourg Pfizer bv Ibuprofen Advil Mono Liquid Caps 200 mg Capsule, soft Oral use Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands Luxembourg Abbott Laboratoires Ibuprofen Brufen forte 600 mg Coated tablet Oral use Avenue Einstein 14 1300 Wavre Belgium Luxembourg Abbott Laboratoires Ibuprofen Brufen granules 600 mg Effervescent granules Oral use Avenue Einstein 14 1300 Wavre Belgium Luxembourg Abbott Laboratoires Ibuprofen Brufen retard 800 mg Prolonged-release Oral use Avenue Einstein 14 tablet 1300 Wavre Belgium Luxembourg Abbott Laboratoires Ibuprofen Brufen 400 mg Coated tablet Oral use Avenue Einstein 14 1300 Wavre Belgium Luxembourg Abbott Laboratoires Ibuprofen Brufen granules 400 mg Effervescent granules Oral use Avenue Einstein 14 1300 Wavre Belgium Luxembourg Abbott Laboratoires Ibuprofen Brufen suspension 40 mg/ml Oral suspension Oral use Avenue Einstein 14 buvable 1300 Wavre Belgium

182

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Luxembourg Simons Georg GmbH Ibuprofen Dismenol N 200 mg Coated tablet Oral use Eckenheimer Landstr 100 60318 Frankfurt/Main Germany Luxembourg Dolorgiet GmbH & Co. KG Ibuprofen Dolgit 600 mg Coated tablet Oral use Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany Luxembourg Dolorgiet GmbH & Co. KG Ibuprofen Dolgit 800 mg Coated tablet Oral use Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany Luxembourg Socobom nv/sa Ibuprofen Dolofin 200 mg Coated tablet Oral use Avenue Louise 149b24 1050 Bruxelles Belgium Luxembourg Socobom nv/sa Ibuprofen Dolofin 200 mg Coated tablet Oral use Avenue Louise 149b24 1050 Bruxelles Belgium Luxembourg Socobom nv/sa Ibuprofen Dolofin 200 mg Coated tablet Oral use Avenue Louise 149b24 1050 Bruxelles Belgium Luxembourg Will-Pharma S.A. Ibuprofen Epsilon 400 mg Coated tablet Oral use Rue du Manil 80 1301 Wavre Belgium

183

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Luxembourg ratiopharm GmbH Ibuprofen lysine Ibu Ratiopharm Lysinat 500 mg Coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Luxembourg Abz-Pharma GmbH Ibuprofen lysine Ibu-Lysin Abz Migraene 684 mg Coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Luxembourg ratiopharm GmbH Ibuprofen lysine Ibu-Lysin Ratiopharm 684 mg Coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Luxembourg ratiopharm GmbH Ibuprofen lysine Ibu-Lysin Ratiopharm 342 mg Coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Luxembourg CT Arzneimittel GmbH Ibuprofen lysine Ibu-Lysin CT 684 mg Coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Luxembourg CT Arzneimittel GmbH Ibuprofen lysine Ibu-Lysin CT 342 mg Coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Luxembourg ratiopharm GmbH Ibuprofen Ibu-Ratiopharm 200 mg Coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany

184

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Luxembourg ratiopharm GmbH Ibuprofen Ibu-Ratiopharm 400 mg Coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Luxembourg ratiopharm GmbH Ibuprofen Ibu-Ratiopharm 600 mg Coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Luxembourg ratiopharm GmbH Ibuprofen Ibu-Ratiopharm 800 mg Prolonged-release Oral use Graf-Arco-Str. 3 tablet 89079 Ulm Germany Luxembourg Hexal AG Ibuprofen Ibuhexal retard 800 mg Prolonged-release Oral use Industriestrasse 25 tablet 83607 Holzkirchen Germany Luxembourg Hexal AG Ibuprofen Ibuhexal 400 mg Coated tablet Oral use Industriestrasse 25 83607 Holzkirchen Germany Luxembourg Hexal AG Ibuprofen Ibuhexal 600 mg Coated tablet Oral use Industriestrasse 25 83607 Holzkirchen Germany Luxembourg Hexal AG Ibuprofen Ibuhexal 800 mg Coated tablet Oral use Industriestrasse 25 83607 Holzkirchen Germany

185

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Luxembourg ratiopharm GmbH Ibuprofen Ibuprofen ratio 200 mg Coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Luxembourg ratiopharm GmbH Ibuprofen Ibuprofen ratio 400 mg Coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Luxembourg CT Arzneimittel GmbH Ibuprofen Ibuprofen ct 500 mg Suppository Rectal use Graf-Arco-Str. 3 89079 Ulm Germany Luxembourg Eurogenerics NV Ibuprofen Ibuprofen EG 40 mg/ml Oral suspension Oral use Esplanade Heysel b22 1020 Bruxelles Belgium Luxembourg Eurogenerics NV Ibuprofen Ibuprofen EG 400 mg Coated tablet Oral use Esplanade Heysel b22 1020 Bruxelles Belgium Luxembourg Eurogenerics NV Ibuprofen Ibuprofen EG 600 mg Coated tablet Oral use Esplanade Heysel b22 1020 Bruxelles Belgium Luxembourg Eurogenerics NV Ibuprofen Ibuprofen EG 800 mg Prolonged-release Oral use Esplanade Heysel b22 tablet 1020 Bruxelles Belgium

186

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Luxembourg Boehringer Ingelheim Ibuprofen Ibuprofen Boehringer 400 mg Capsule, soft Oral use International GmbH Ingelheim Binger Straße 173 55216 Ingelheim am Rhein Germany Luxembourg Mylan bvba/sprl Ibuprofen lysine Ibuprofen Lysine Mylan 200 mg Coated tablet Oral use Terhulpsesteenweg 6a 1560 Hoeilaart Belgium Luxembourg Mylan bvba/sprl Ibuprofen lysine Ibuprofen Lysine Mylan 400 mg Coated tablet Oral use Terhulpsesteenweg 6a 1560 Hoeilaart Belgium Luxembourg Mylan bvba/sprl Ibuprofen lysine Ibuprofen Lysine Mylan 200 mg Coated tablet Oral use Terhulpsesteenweg 6a Pharma 1560 Hoeilaart Belgium Luxembourg Mylan bvba/sprl Ibuprofen lysine Ibuprofen Lysine Mylan 400 mg Coated tablet Oral use Terhulpsesteenweg 6a Pharma 1560 Hoeilaart Belgium Luxembourg Sandoz nv/sa Ibuprofen Ibuprofen Sandoz 40 mg/ml Oral suspension Oral use Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

187

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Luxembourg Abbott S.A-N.V. Ibuprofen Malafene 100mg/5ml 20 mg/ml Syrup Oral use Avenue Einstein 14 1300 Wavre Belgium Luxembourg Reckitt Benckiser Healthcare Ibuprofen Nurofen fastcaps 200 mg Capsule, soft Oral use nv/sa Allée de la recherche 20 1070 Bruxelles Belgium Luxembourg Reckitt Benckiser Healthcare Ibuprofen Nurofen fastpowder 400 mg Powder for oral Oral use nv/sa solution Allée de la recherche 20 1070 Bruxelles Belgium Luxembourg Reckitt Benckiser Healthcare Ibuprofen Nurofen fasttabs 684 mg Film-coated tablet Oral use nv/sa Allée de la recherche 20 1070 Bruxelles Belgium Luxembourg Reckitt Benckiser Healthcare Ibuprofen Nurofen 200 mg Coated tablet Oral use nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

188

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Luxembourg Reckitt Benckiser Healthcare Ibuprofen Nurofen 400 400 mg Coated tablet Oral use nv/sa Allée de la recherche 20 1070 Bruxelles Belgium Luxembourg Reckitt Benckiser Healthcare Ibuprofen lysine Nurofen lysine 342 mg Film-coated tablet Oral use nv/sa Allée de la recherche 20 1070 Bruxelles Belgium Luxembourg Reckitt Benckiser Healthcare Ibuprofen lysine Nurofen lysine 684 mg Film-coated tablet Oral use nv/sa Allée de la recherche 20 1070 Bruxelles Belgium Luxembourg Johnson & Johnson Ibuprofen lysine Perdofemina 684 mg Film-coated tablet Oral use Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium Luxembourg Johnson & Johnson Ibuprofen lysine Perdophen 684 mg Coated tablet Oral use Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium

189

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Luxembourg Dolorgiet GmbH & Co. KG Ibuprofen Schmerz-Dolgit 400 mg Capsule, soft Oral use Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany Luxembourg Zambon SA/NV Ibuprofen Spidifen 200 mg Granules for oral Oral use E.Demunterlaan 1/9 solution 1090 Brussels Belgium Luxembourg Zambon SA/NV Ibuprofen Spidifen 200 mg Tablet Oral use E.Demunterlaan 1/9 1090 Brussels Belgium Luxembourg Zambon SA/NV Ibuprofen Spidifen 200 mg Effervescent tablet Oral use E.Demunterlaan 1/9 1090 Brussels Belgium Luxembourg Zambon SA/NV Ibuprofen Spidifen 400 mg Film-coated tablet Oral use E.Demunterlaan 1/9 1090 Brussels Belgium Malta Mepha Lda. Ibuprofen Irfen-200 Quiktabs 200 mg Film-coated tablet Oral use Lagoas Park, 2740-298 Porto Salvo Portugal

190

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Malta Reckitt Benckiser Healthcare Ibuprofen Nurofen 200mg 200 mg Coated tablet Oral use International Ltd. Thane Road Nottingham NG90 2DB United Kingdom

Malta Reckitt Benckiser Healthcare Ibuprofen Nurofen Express 200 mg Capsule, soft Oral use International Ltd. Capsules, Soft 200mg Thane Road Nottingham NG90 2DB United Kingdom Malta Reckitt Benckiser Healthcare Ibuprofen/Pseudoep NUROFEN COLD AND 200 Coated tablet Oral use International Ltd. hedrine FLU TABLETS mg/30mg Thane Road hydrochloride Nottingham NG90 2DB United Kingdom Malta Fair-Med Healthcare GmbH Ibuprofen Ibuprofen FAIR-MED 200 mg Film-coated tablet Oral use Planckstr. 13 200 mg film-coated 22765 Hamburg tablet Germany Malta A. C. R. A. F. SpA (Aziende Ibuprofen Moment 200 200 mg Coated tablet Oral use Chimiche Riunite Angelini Francesco) Viale Amelia 70, Rome 00181 Italy

191

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Malta Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 200 mg Coated tablet Oral use Reykjavíkurvegi 76-78 200mg Film-Coated 220 Hafnarfjörður Tablets Iceland Malta Actavis Group PTC ehf Ibuprofen Ibufen Coated Tablets 200 mg Coated tablet Oral use Reykjavíkurvegi 76-78 200mg 220 Hafnarfjörður Iceland Malta A. C. R. A. F. SpA (Aziende Ibuprofen Moment 200 200 mg/ml Oral drops, solution Oral use Chimiche Riunite Angelini Francesco) Viale Amelia 70, Rome 00181 Italy Malta Fair-Med Healthcare GmbH Ibuprofen Ibuprofen FAIR-MED 400 mg Film-coated tablet Oral use Planckstr. 13 400 mg film-coated 22765 Hamburg tablet Germany Malta Goldshield Pharmaceuticals Ibuprofen Fenbid Spansule 300 mg Modified-release Oral use Ltd Capsules capsule NLA Tower 12-16 Addiscombe Road Croydon Surrey CR0 OXT United Kingdom

192

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Malta Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 400 mg Coated tablet Oral use Reykjavíkurvegi 76-78 400mg Film-Coated 220 Hafnarfjörður Tablets Iceland Malta Actavis Group PTC ehf Ibuprofen Ibufen Coated Tablets 400 mg Coated tablet Oral use Reykjavíkurvegi 76-78 400mg 220 Hafnarfjörður Iceland Malta Dolorgiet GmbH & Co. KG Ibuprofen Dolgit 600 600 mg Coated tablet Oral use Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany Malta Fair-Med Healthcare GmbH Ibuprofen Ibuprofen FAIR-MED 600 mg Film-coated tablet Oral use Planckstr. 13 600 mg film-coated 22765 Hamburg tablet Germany Malta Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 600 mg Coated tablet Oral use Reykjavíkurvegi 76-78 600mg Film-Coated 220 Hafnarfjörður Tablets Iceland Malta Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 800 mg Coated tablet Oral use Reykjavíkurvegi 76-78 800mg Film-Coated 220 Hafnarfjörður Tablets Iceland

193

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Malta Omega Pharma Ltd Ibuprofen Solpadeine Migraine 200 mg Film-coated tablet Oral use 1st Floor codeine phosphate Ibuprofen & Codeine Vauxhall Bridge Road 32 hemihydrate Tablets London SW1V 2SA United Kingdom Malta Reckitt Benckiser Healthcare Ibuprofen Nurofen Plus 200 mg Tablet Oral use International Ltd. codeine phosphate Thane Road hemihydrate Nottingham NG90 2DB United Kingdom

Malta Pfizer Healthcare Ireland Ibuprofen Advil Cold & Flu Coated 200 mg Coated tablet Oral use 9 Riverwalk pseudoephedrine Tablets National Digital Park hydrochloride Citywest Business Campus Dublin 24 Ireland Malta Reckitt Benckiser Healthcare Ibuprofen Lemsip Flu 12Hr 300 mg Modified-release Oral use International Ltd. pseudoephedrine Ibuprofen + capsule Thane Road hydrochloride Pseudoephedrine Nottingham NG90 2DB United Kingdom

Malta Dr. Max Pharma Ltd. Ibuprofen Ibuprofen Dr. Max 200 mg Film-coated tablet Oral use First Floor Roxburge House, 200mg Regent Street 273-287 W1B 2HA London United Kingdom

194

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Malta Dr. Max Pharma Ltd. Ibuprofen Ibuprofen Dr. Max 400 mg Film-coated tablet Oral use First Floor Roxburge House, 400mg Regent Street 273-287 W1B 2HA London United Kingdom Norway Abbott Scandinavia AB Ibuprofen Brufen Retard 800 mg Prolonged-release Oral use P.O Box 1498 tablet SE-171 29 Solna Sweden Norway Infirst Healthcare Ltd. Ibuprofen Flarin 400 mg Capsule, soft Oral use Strand 265 London WC2R 1BH United Kingdom Norway Infirst Healthcare Ltd. Ibuprofen Flarin 200 mg Capsule, soft Oral use Strand 265 London WC2R 1BH United Kingdom Norway Vitabalans Oy Ibuprofen Ibumax 400 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Norway Vitabalans Oy Ibuprofen Ibumax 200 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland

195

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Norway Vitabalans Oy Ibuprofen Ibumax 600 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Norway Takeda Nycomed AS Ibuprofen Ibumetin 600 mg Tablet Oral use P.O. Box 205 NO-1372 Asker Norway Norway Takeda Nycomed AS Ibuprofen Ibumetin 400 mg Tablet Oral use P.O. Box 205 NO-1372 Asker Norway Norway Takeda Nycomed AS Ibuprofen Ibumetin 200 mg Tablet Oral use P.O. Box 205 NO-1372 Asker Norway Norway Takeda Nycomed AS Ibuprofen Ibumetin 20 mg/ml Oral suspension Oral use P.O. Box 205 NO-1372 Asker Norway Norway Farmalider S.A. Ibuprofen Ibuprofen Farmalider 40 mg/ml Oral suspension Oral use C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain Norway Farmalider S.A. Ibuprofen Ibuprofen Farmalider 20 mg/ml Oral suspension Oral use C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

196

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Norway Galpharm Healthcare Ibuprofen Ibuprofen Orion 400 mg Film-coated tablet Oral use Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom Norway Galpharm Healthcare Ibuprofen Ibuprofen Orion 200 mg Film-coated tablet Oral use Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom Norway ratiopharm GmbH Ibuprofen Ibuprofen ratiopharm 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Norway ratiopharm GmbH Ibuprofen Ibuprofen ratiopharm 200 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Norway ratiopharm GmbH Ibuprofen Ibuprofen ratiopharm 600 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany

197

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Norway Weifa AS Ibuprofen Ibux 600 mg Suppository Rectal use P.O.Box 6733 Etterstad NO-0609 Oslo Norway Norway Weifa AS Ibuprofen Ibux 600 mg Film-coated tablet Oral use P.O.Box 6733 Etterstad NO-0609 Oslo Norway Norway Weifa AS Ibuprofen Ibux 400 mg Film-coated tablet Oral use P.O.Box 6733 Etterstad NO-0609 Oslo Norway Norway Weifa AS Ibuprofen Ibux 200 mg Film-coated tablet Oral use P.O.Box 6733 Etterstad NO-0609 Oslo Norway Norway Weifa AS Ibuprofen Ibux 200 mg Capsule, soft Oral use P.O.Box 6733 Etterstad NO-0609 Oslo Norway Norway Weifa AS Ibuprofen Ibux 400 mg Capsule, soft Oral use P.O.Box 6733 Etterstad NO-0609 Oslo Norway Norway Weifa AS Ibuprofen Ibux 20 mg/ml Oral suspension Oral use P.O.Box 6733 Etterstad NO-0609 Oslo Norway

198

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Norway Actavis Group PTC ehf Ibuprofen Ifenin 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Norway Actavis Group PTC ehf Ibuprofen Ifenin 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Poland Teva Pharmaceuticals Polska Ibuprofen Ibuprofen 123ratio 200 mg Film-coated tablet Oral use Sp.z o.o. 53 Emilii Plater st. 00-113 Warsaw Poland Poland Teva Pharmaceuticals Polska Ibuprofen Ibuprofen 123ratio 400 mg Film-coated tablet Oral use Sp.z o.o. 53 Emilii Plater st. 00-113 Warsaw Poland Poland BGP Products Poland Sp. z Ibuprofen Brufen 400 mg Effervescent granules Oral use o.o. Postepu st. 21B 02-676 Warsaw Poland Poland BGP Products Poland Sp. z Ibuprofen Brufen 20 mg/ml Oral suspension Oral use o.o. Postepu st. 21B 02-676 Warsaw Poland

199

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland BGP Products Poland Sp. z Ibuprofen Brufen Forte 40 mg/ml Oral suspension Oral use o.o. Postepu st. 21B 02-676 Warsaw Poland Poland BGP Products Poland Sp. z Ibuprofen ABFEN 200 mg Effervescent granules Oral use o.o. Postepu st. 21B 02-676 Warsaw Poland Poland Actavis Group PTC ehf Ibuprofen Ifenin 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Poland Actavis Group PTC ehf Ibuprofen Ifenin Forte 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Poland Aflofarm Farmacja Polska Ibuprofen Ibuprofen AFL 200 mg Coated tablet Oral use Sp. z o.o. Partyzancka st. 133/151 95-200 Pabianice Poand Poland Aflofarm Farmacja Polska Ibuprofen Ibuprofen Aflofarm 400 mg Coated tablet Oral use Sp. z o.o. Partyzancka st. 133/151 95-200 Pabianice Poand

200

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Aflofarm Farmacja Polska Ibuprofen Ibuprofen Aflofarm 200 mg Coated tablet Oral use Sp. z o.o. Partyzancka st. 133/151 95-200 Pabianice Poand Poland Aflofarm Farmacja Polska Ibuprofen Kidofen Duo (100 mg + Oral suspension Oral use Sp. z o.o. paracetamol 125 mg)/5 Partyzancka st. 133/151 ml 95-200 Pabianice Poand Poland APC Instytut Sp. z o.o. Ibuprofen Galprofen 200 mg Coated tablet Oral use Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland Poland APC Instytut Sp. z o.o. Ibuprofen Galprofen Max 400 mg Coated tablet Oral use Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland Poland APC Instytut Sp. z o.o. Ibuprofen Ibuprofen APC 200 mg Coated tablet Oral use Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland Poland APC Instytut Sp. z o.o. Ibuprofen Ibuprofen APC Max 400 mg Coated tablet Oral use Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

201

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland APC Instytut Sp. z o.o. Ibuprofen Tesprofen 200 mg Coated tablet Oral use Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland Poland Banner Pharmacaps Europe Ibuprofen Ibuprofen Banner 400 mg Capsule, soft Oral use B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands Poland Berlin-Chemie AG Ibuprofen MIG 400 mg Film-coated tablet Oral use Glienicker Weg 125 12489 Berlin Germany Poland Berlin-Chemie AG Ibuprofen MIG dla dzieci Forte o 40 mg/ml Oral suspension Oral use Glienicker Weg 125 smaku truskawkowym 12489 Berlin Germany Poland Biofarm Sp. z o.o. Dexibuprofen Seractil 200 mg Film-coated tablet Oral use Wałbrzyska st. 13 60-198 Poznan Poland Poland Biofarm Sp. z o.o. Dexibuprofen Seractil 400 mg Film-coated tablet Oral use Wałbrzyska st. 13 60-198 Poznan Poland

202

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Bio-Profil Polska Sp. z o.o. Ibuprofen Rinafen Zatoki 200 mg Tablet Oral use 135 Trakt Lubelsi st. pseudoephedrine 30 mg 04-790 Warsaw hydrochloride Poalnd Poland Boehringer Ingelheim Ibuprofen Buscofem 400 mg Capsule, soft Oral use International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany Poland Fair-Med Healthcare GmbH Ibuprofen Ibuprofen Fair-Med 200 mg Film-coated tablet Oral use Planckstr. 13 22765 Hamburg Germany Poland Fair-Med Healthcare GmbH Ibuprofen Ibuprofen Fair-Med 400 mg Film-coated tablet Oral use Planckstr. 13 22765 Hamburg Germany Poland Fair-Med Healthcare GmbH Ibuprofen Ibuprofen Fair-Med 600 mg Film-coated tablet Oral use Planckstr. 13 22765 Hamburg Germany Poland Farmalider S.A. Ibuprofen Ibuprofen Farmalider 20 mg/ml Oral suspension Oral use C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

203

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland SEQUOIA Sp. z o.o. Ibuprofen Ibuprofen Liderfarm 20 mg/ml Oral suspension Oral use Ostródzka 74N 03-289 Warsaw Poland Poland Galpharm Healthcare Ibuprofen Ibuprofen Galpharm 200 mg Film-coated tablet Oral use Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom Poland Galpharm Healthcare Ibuprofen Ibuprofen Galpharm 400 mg Film-coated tablet Oral use Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom Poland Laboratorium Galenowe Ibuprofen Ibuprofen LGO 400 mg Film-coated tablet Oral use Olsztyn Sp. z o.o. Spóldzielcza st. 25A 11-001 Dywity Poland

204

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Laboratorium Galenowe Ibuprofen Ibuprofen LGO 200 mg Film-coated tablet Oral use Olsztyn Sp. z o.o. Spóldzielcza st. 25A 11-001 Dywity Poland Poland Pabianickie Zakłady Ibuprofen Ibupar 200 mg Coated tablet Oral use Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland Poland Pabianickie Zakłady Ibuprofen Ibupar forte 400 mg Film-coated tablet Oral use Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland Poland Pabianickie Zakłady Ibuprofen Ibuprofen-Pabi 200 mg Coated tablet Oral use Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland Poland Polfarmex S.A. Ibuprofen Ibuprofen Polfarmex 200 mg Film-coated tablet Oral use 9 Józefów st, 99-300 Kutno Poland

205

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Przedsiębiorstwo Produkcji Ibuprofen Ibum 200 mg Capsule, soft Oral use Farmaceutycznej HASCO- LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland Poland Przedsiębiorstwo Produkcji Ibuprofen Ibum 20 mg/ml Oral suspension Oral use Farmaceutycznej HASCO- LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland Poland Przedsiębiorstwo Produkcji Ibuprofen Ibum 20 mg/ml Oral suspension Oral use Farmaceutycznej HASCO- LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland Poland Przedsiębiorstwo Produkcji Ibuprofen Ibum Forte 400 mg Capsule, soft Oral use Farmaceutycznej HASCO- LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland

206

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Przedsiębiorstwo Produkcji Ibuprofen Ibum Forte Minicaps 400 mg Capsule, soft Oral use Farmaceutycznej HASCO- LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland Poland Przedsiębiorstwo Produkcji Ibuprofen Ibum Grip 200 mg Film-coated tablet Oral use Farmaceutycznej HASCO- pseudoephedrine 30 mg LEK S.A. hydrochloride 242E Żmigroddzka st,. 51-131 Wroclaw Poland Poland Przedsiębiorstwo Produkcji Ibuprofen Ibum Zatoki 200 mg Film-coated tablet Oral use Farmaceutycznej HASCO- pseudoephedrine 30 mg LEK S.A. hydrochloride 242E Żmigroddzka st,. 51-131 Wroclaw Poland Poland Przedsiębiorstwo Produkcji Ibuprofen Ibuprofen Hasco 200 mg Capsule, soft Oral use Farmaceutycznej HASCO- LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland

207

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Teva Pharmaceuticals Polska Ibuprofen Bufenik 40 mg/ml Syrup Oral use Sp.z o.o. 53 Emilii Plater st. 00-113 Warsaw Poland Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen 200 mg Film-coated tablet Oral use S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen Caps 400 mg Capsule, soft Oral use S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen dla dzieci Forte 40 mg/ml Oral suspension Oral use S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

208

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen dla dzieci o 20 mg/ml Oral suspension Oral use S.A. smaku truskawkowym ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen Express 200 mg Film-coated tablet Oral use S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen Express 200 mg Capsule, soft Oral use S.A. Femina ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen Express Forte 400 mg Oral powder Oral use S.A. rozpuszczalny ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

209

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen Express TAB 400 mg Film-coated tablet Oral use S.A. 400 mg ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen Forte Express 400 mg Film-coated tablet Oral use S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen na ból pleców 300 mg Prolonged-realease Oral use S.A. capsule ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen Plus 200 mg Film-coated tablet Oral use S.A. codeine phosphate 12,8 mg ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

210

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen Zatoki 200 mg Film-coated tablet Oral use S.A. pseudoephedrine 30 mg ul. Okunin 1 hydrochloride 05-100 Nowy Dwor Mazowiecki Poland Poland Reckitt Benckiser (Poland) Ibuprofen Nurofen Ultima 200 mg Film-coated tablet Oral use S.A. paracetamol 500 mg ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland Poland Rockspring Healthcare Ibuprofen Brufen Plus 400 mg Film-coated tablet Oral use Limited codeine phosphate 30 mg 38/40 Chamberlayne Road hemihydrate London NW10 3JE United Kingdom Poland US Pharmacia Sp. z o.o. Ibuprofen Acatar Zatoki 200 mg Film-coated tablet Oral use Ziebicka st. 40 pseudoephedrine 30 mg 50-507 Wroclaw hydrochloride Poalnd Poland US Pharmacia Sp. z o.o. Ibuprofen Acatar Zatoki Tabs 200 mg Coated tablet Oral use Ziebicka st. 40 pseudoephedrine 6,1 mg 50-507 Wroclaw hydrochloride Poalnd

211

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland US Pharmacia Sp. z o.o. Ibuprofen Ibuprom 200 mg Film-coated tablet Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd Poland US Pharmacia Sp. z o.o. Ibuprofen Ibuprom DUO 400 mg Film-coated tablet Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd Poland US Pharmacia Sp. z o.o. Ibuprofen Ibuprom Max 400 mg Coated tablet Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd Poland US Pharmacia Sp. z o.o. Ibuprofen Ibuprom Max Sprint 400 mg Capsule, soft Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd Poland US Pharmacia Sp. z o.o. Ibuprofen Ibuprom Sprint Caps 200 mg Capsule, soft Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd Poland US Pharmacia Sp. z o.o. Ibuprofen Ibuprom Zatoki 200 mg Film-coated tablet Oral use Ziebicka st. 40 pseudoephedrine 30 mg 50-507 Wroclaw hydrochloride Poalnd Poland US Pharmacia Sp. z o.o. Ibuprofen Ibuprom Zatoki Tabs 200 mg Coated tablet Oral use Ziebicka st. 40 phenylephrine 6,1 mg 50-507 Wroclaw hydrochloride Poalnd

212

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Vitabalans Oy Ibuprofen Ibumax 200 mg 200 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Poland Vitabalans Oy Ibuprofen Ibumax 400 mg 400 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Poland Vitabalans Oy Ibuprofen Ibumax Forte 600 mg 600 mg Film-coated tablet Oral use Varastokatu 8 13500 Hämeenlinna Finland Poland Wrafton Laboratories Ibuprofen Ibuprofen Lysine 400 mg Film-coated tablet Oral use Limited Perrigo Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom Poland Wrafton Laboratories Ibuprofen Ibuprofen Lysine 200 mg Film-coated tablet Oral use Limited Perrigo Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom

213

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Zakłady Farmaceutyczne Ibuprofen Ibufen dla dzieci FORTE 40 mg/ml Oral suspension Oral use POLPHARMA S.A. o smaku Pelpinska St. 19 truskawkowym 83-200 Starogard Gdanski Poland Poland Zakłady Farmaceutyczne Ibuprofen Ibufen Junior 200 mg Capsule, soft Oral use POLPHARMA S.A. Pelpinska St. 19 83-200 Starogard Gdanski Poland Poland Zakłady Farmaceutyczne Ibuprofen Metafen 200 mg Tablet Oral use POLPHARMA S.A. paracetamol 325 mg Pelpinska St. 19 83-200 Starogard Gdanski Poland Poland Zakłady Farmaceutyczne Ibuprofen Metafen Zatoki 200 mg Tablet Oral use POLPHARMA S.A. pseudoephedrine 30 mg Pelpinska St. 19 hydrochloride 83-200 Starogard Gdanski Poland Poland Zambon S.p.A. Ibuprofen Spedifen 400 400 mg Film-coated tablet Oral use Via Lillo del Duca 10 20091, Bresso (Mi) Italy

214

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Zentiva, k.s. Ibuprofen Ibalgin 200 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Poland Zentiva, k.s. Ibuprofen Ibalgin Fast 400 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Poland Zentiva, k.s. Ibuprofen Ibalgin Maxi 400 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Poland Zentiva, k.s. Ibuprofen Modafen 200 mg Film-coated tablet Oral use U kabelovny 130 pseudoephedrine 30 mg 102 37 Praha 10 hydrochloride Dolní Měcholupy Czech Republic Poland Zentiva, k.s. Ibuprofen Modafen Grip 200 mg Film-coated tablet Oral use U kabelovny 130 phenylephrine 5 mg 102 37 Praha 10 hydrochloride Dolní Měcholupy Czech Republic

215

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Poland Zentiva, k.s. Ibuprofenum Modafen baby 100 mg/5 ml Oral suspension Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Portugal Abbott Laboratórios, Lda. Ibuprofen Brufen 200 mg Effervescent granules Oral use Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal Portugal Abbott Laboratórios, Lda. Ibuprofen Brufen 200 mg Film-coated tablet Oral use Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal Portugal Abbott Laboratórios, Lda. Ibuprofen Brufen 600 mg Effervescent granules Oral use Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal Portugal Abbott Laboratórios, Lda. Ibuprofen Brufen 400 mg Effervescent granules Oral use Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

216

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Abbott Laboratórios, Lda. Ibuprofen Brufen 600 mg Film-coated tablet Oral use Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal Portugal Abbott Laboratórios, Lda. Ibuprofen Brufen 400 mg Film-coated tablet Oral use Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal Portugal Abbott Laboratórios, Lda. Ibuprofen Brufen Retard 800 mg Prolonged-release Oral use Estrada de Alfragide, 67 - tablet Alfrapark - Edificio D 2610-008 Amadora Portugal Portugal Abbott Laboratórios, Lda. Ibuprofen Brufen Sem Açúcar 40 mg/ml Oral suspension Oral use Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal Portugal Abbott Laboratórios, Lda. Ibuprofen Brufen Suspensão 20 mg/ml Oral suspension Oral use Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

217

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Boehringer Ingelheim, Lda. Ibuprofen Buskofem 200 mg Capsule, soft Oral use Avenida de Pádua, 11 1800-294 Lisboa Portugal Portugal Boehringer Ingelheim Ibuprofen Buskofem 400 mg Capsule, soft Oral use International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany Portugal Laboratórios Basi - Indústria Ibuprofen Dimidon 400 mg Film - coated tablet Oral use Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal Portugal Novartis Consumer Health - Ibuprofen Dolocyl 200 mg Coated tablet Oral use Produtos Farmacêuticos e Nutrição, Lda. Avenida Professor Doutor Cavaco Silva, 10 E, Taguspark 2740-255 Porto Salvo Portugal Portugal Jaba Recordati, S. A. Ibuprofen Dolomate 200 200 mg Powder for oral Oral use Lagoas Park, Edificio 5, suspension Torre C, Piso 3 2740-298 Porto Salvo Portugal

218

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Zambon - Produtos Ibuprofen Faspic 200 200 mg Granules for oral Oral use Farmacêuticos, Lda. solution Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal Portugal Zambon - Produtos Ibuprofen Faspic 400 400 mg Granules for oral Oral use Farmacêuticos, Lda. solution Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal Portugal Zambon - Produtos Ibuprofen Faspic 600 600 mg Granules for oral Oral use Farmacêuticos, Lda. solution Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal Portugal Zambon - Produtos Ibuprofen Fenpic 400 mg Film-coated tablet Oral use Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

219

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Confar - Consórcio Ibuprofen Frenidor 200 mg Coated tablet Oral use Farmacêutico, Lda. Rua Félix Correia, 1-B 1500-271 Lisboa Portugal Portugal Confar - Consórcio Ibuprofen Frenidor 200 mg Granules Oral use Farmacêutico, Lda. Rua Félix Correia, 1-B 1500-271 Lisboa Portugal Portugal Bene Farmacêutica, Lda. Ibuprofen Ib-u-ron 600 mg Film-coated tablet Oral use Avenida D. João II, Lote 1.06.2.2.C - 1º B 1990-095 Lisboa Portugal Portugal Bene Farmacêutica, Lda. Ibuprofen Ib-u-ron 40 mg/ml Oral suspension Oral use Avenida D. João II, Lote 1.06.2.2.C - 1º B 1990-095 Lisboa Portugal Portugal Bene Farmacêutica, Lda. Ibuprofen Ib-u-ron 400 mg Film-coated tablet Oral use Avenida D. João II, Lote 1.06.2.2.C - 1º B 1990-095 Lisboa Portugal

220

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal BGP Products, Unipessoal, Ibuprofen Ibuprofeno Premier 600 mg Film-coated tablet Oral use Lda. Estrada de Alfragide, 67 - Alfrapark, Edificio D 2610-008 Amadora Portugal Portugal BGP Products, Unipessoal, Ibuprofen Ibuprofeno Premier 400 mg Film-coated tablet Oral use Lda. Estrada de Alfragide, 67 - Alfrapark, Edificio D 2610-008 Amadora Portugal Portugal Actavis Group PTC ehf Ibuprofen Ibuprofeno Actavis 800 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Portugal Actavis Group PTC ehf Ibuprofen Ibuprofeno Actavis 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Portugal Actavis Group PTC ehf Ibuprofen Ibuprofeno Actavis 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Portugal Actavis Group PTC ehf Ibuprofen Ibuprofeno Actavis 600 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

221

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Alter, S.A. Ibuprofen Ibuprofeno Alter 400 400 mg Film-coated tablet Oral use Estrada Marco do Grilo - mg Comprimidos Zemouto revestidos 2830 Coina Portugal Portugal Alter, S.A. Ibuprofen Ibuprofeno Alter 600 600 mg Film-coated tablet Oral use Estrada Marco do Grilo - mg Comprimidos Zemouto Revestidos 2830 Coina Portugal Portugal Laboratórios Azevedos - Ibuprofen Ibuprofeno Azevedos 400 mg Film-coated tablet Oral use Indústria Farmacêutica, S.A. 400 mg Comprimidos Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal Portugal Laboratórios Azevedos - Ibuprofen Ibuprofeno Azevedos 600 mg Film-coated tablet Oral use Indústria Farmacêutica, S.A. 600 mg Comprimidos Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal

222

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Ciclum Farma Unipessoal, Ibuprofen Ibuprofeno Ciclum 600 mg Film-coated tablet Oral use Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal Portugal Ciclum Farma Unipessoal, Ibuprofen Ibuprofeno Ciclum 400 mg Film-coated tablet Oral use Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal Portugal Cinfa Portugal, Lda. Ibuprofen Ibuprofeno Cinfa 400 mg Film-coated tablet Oral use Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal Portugal Cinfa Portugal, Lda. Ibuprofen Ibuprofeno Cinfa 600 mg Film-coated tablet Oral use Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal

223

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Farmalider S.A. Ibuprofen Ibuprofeno Codramol 200 mg Granules for oral Oral use C/ Aragoneses, 15 solution Alcobendas (Madrid), 28108 Spain Portugal Farmalider S.A. Ibuprofen Ibuprofeno Codramol 400 mg Film-coated tablet Oral use C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain Portugal Farmalider S.A. Ibuprofen Ibuprofeno Codramol 600 mg Film-coated tablet Oral use C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain Portugal Farmalider S.A. Ibuprofen Ibuprofeno Farmalider 200 mg Granules for oral Oral use C/ Aragoneses, 15 solution Alcobendas (Madrid), 28108 Spain Portugal Farmoz - Sociedade Técnico Ibuprofen Ibuprofeno Farmoz 200 mg Film-coated tablet Oral use Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal Portugal Farmoz - Sociedade Técnico Ibuprofen Ibuprofeno Farmoz 400 mg Film-coated tablet Oral use Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal

224

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Generis Farmacêutica, S.A. Ibuprofen Ibuprofeno Generis 600 mg Granules for oral Oral use Rua João de Deus, 19 solution 2700-487 Amadora Portugal Portugal Generis Farmacêutica, S.A. Ibuprofen Ibuprofeno Generis 400 mg Granules for oral Oral use Rua João de Deus, 19 solution 2700-487 Amadora Portugal Portugal Generis Farmacêutica, S.A. Ibuprofen Ibuprofeno Generis 200 mg Coated tablet Oral use Rua João de Deus, 19 2700-487 Amadora Portugal Portugal Generis Farmacêutica, S.A. Ibuprofen Ibuprofeno Generis 20 20 mg/ml Oral suspension Oral use Rua João de Deus, 19 mg/ml Suspensão oral 2700-487 Amadora Portugal Portugal Generis Farmacêutica, S.A. Ibuprofen Ibuprofeno Generis 400 400 mg Film-coated tablet Oral use Rua João de Deus, 19 mg Comprimidos 2700-487 Amadora Portugal Portugal Generis Farmacêutica, S.A. Ibuprofen Ibuprofeno Generis 600 600 mg Coated tablet Oral use Rua João de Deus, 19 mg Comprimidos 2700-487 Amadora Revestidos Portugal

225

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Germed Farmacêutica, Lda. Ibuprofen Ibuprofeno Germed 400 mg Film-coated tablet Oral use Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal Portugal Germed Farmacêutica, Lda. Ibuprofen Ibuprofeno Germed 600 mg Film-coated tablet Oral use Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal Portugal Labesfal Genéricos, S.A. Ibuprofen Ibuprofeno Labesfal 200 mg Film-coated tablet Oral use Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal Portugal Labesfal Genéricos, S.A. Ibuprofen Ibuprofeno Labesfal 400 mg Film-coated tablet Oral use Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal

226

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Labesfal Genéricos, S.A. Ibuprofen Ibuprofeno Labesfal 600 mg Film-coated tablet Oral use Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal Portugal Laboratórios Basi - Indústria Ibuprofen Ibuprofeno Mer 600 mg Coated tablet Oral use Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal Portugal Laboratórios Basi - Indústria Ibuprofen Ibuprofeno Mer 400 mg Coated tablet Oral use Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal Portugal OM Pharma, S.A. Ibuprofen Ibuprofeno OM Pharma 200 mg Film - coated tablet Oral use R. da Indústria, 2 - Quinta Grande 2610 - 088 Amadora - Lisboa Portugal

227

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Pharmakern Portugal - Ibuprofen Ibuprofeno Pharmakern 400 mg Film - coated tablet Oral use Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal Portugal Pharmakern Portugal - Ibuprofen Ibuprofeno Pharmakern 600 mg Film - coated tablet Oral use Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal Portugal Sanofi - Produtos Ibuprofen Ibalgin 400 mg Film - coated tablet Oral use Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7, 3º Piso 2740-244 Porto Salvo Portugal Portugal Sanofi - Produtos Ibuprofen Ibalgin 200 mg Film - coated tablet Oral use Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7, 3º Piso 2740-244 Porto Salvo Portugal

228

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Pharmakern Portugal - Ibuprofen Ibuprofeno Pharmakern 20 mg/ml Oral suspension Oral use Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal Portugal Pharmakern Portugal - Ibuprofen Ibuprofeno Pharmakern 400 mg Effervescent granules Oral use Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal Portugal Pharmakern Portugal - Ibuprofen Ibuprofeno Pharmakern 200 mg Effervescent granules Oral use Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

229

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Pharmakern Portugal - Ibuprofen Ibuprofeno Betude 200 mg Film-coated tablet Oral use Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal Portugal Pharmakern Portugal - Ibuprofen Ibuprofeno Pharmakern 600 mg Effervescent granules Oral use Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal Portugal Pharmakern Portugal - Ibuprofen Ibuprofeno Betude 400 mg Film-coated tablet Oral use Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

230

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Pharmakern Portugal - Ibuprofen Ibuprofeno Betude 600 mg Film-coated tablet Oral use Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal Portugal Farmalider S.A. Ibuprofen Ibuprofeno Poindol 600 mg Film-coated tablet Oral use C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain Portugal Farmalider S.A. Ibuprofen Ibuprofeno Poindol 400 mg Film-coated tablet Oral use C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain Portugal Ratiopharm - Comércio e Ibuprofen Ibuprofeno Ratiopharm 200 mg Film - coated tablet Oral use Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal

231

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Ratiopharm - Comércio e Ibuprofen Ibuprofeno Ratiopharm 400 mg Film - coated tablet Oral use Indústria de Produtos 400 mg Comprimidos Farmacêuticos, Lda. Revestidos Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal Portugal Ratiopharm - Comércio e Ibuprofen Ibuprofeno Ratiopharm 600 mg Film - coated tablet Oral use Indústria de Produtos 600 mg Comprimidos Farmacêuticos, Lda. Revestidos Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal Portugal Sandoz Farmacêutica, Lda. Ibuprofen Ibuprofeno Sandoz 400 mg Film - coated tablet Oral use Avenida Professor Doutor Cavaco Silva, 10E - Taguspark 2740-255 Porto Salvo Portugal Portugal Sandoz Farmacêutica, Lda. Ibuprofen Ibuprofeno Sandoz 600 mg Film - coated tablet Oral use Avenida Professor Doutor Cavaco Silva, 10E - Taguspark 2740-255 Porto Salvo Portugal

232

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Sandoz Farmacêutica, Lda. Ibuprofen Ibuprofeno Sandoz 200 mg Film - coated tablet Oral use Avenida Professor Doutor Cavaco Silva, 10E - Taguspark 2740-255 Porto Salvo Portugal Portugal ToLife - Produtos Ibuprofen Ibuprofeno Tolife 200 mg Film-coated tablet Oral use Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal Portugal ToLife - Produtos Ibuprofen Ibuprofeno Tolife 400 mg Film-coated tablet Oral use Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal Portugal ToLife - Produtos Ibuprofen Ibuprofeno Tolife 600 mg Granules for oral Oral use Farmacêuticos, S.A. solution Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal

233

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal ToLife - Produtos Ibuprofen Ibuprofeno Tolife 400 mg Granules for oral Oral use Farmacêuticos, S.A. solution Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal Portugal ToLife - Produtos Ibuprofen Ibuprofeno Tolife 600 mg Film-coated tablet Oral use Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal Portugal Sanofi - Produtos Ibuprofen Ibuprofeno Zentiva 400 mg Film-coated tablet Oral use Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7, 3º Piso 2740-244 Porto Salvo Portugal Portugal Farbio - Produtos Ibuprofen Kifen 200 mg Dispersible tablet Oral use Farmacêuticos Unipessoal, Lda. Largo Alexandre Herculano, 2 7050-110 Montemor-O- Novo Portugal

234

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Angelini Farmacêutica, Lda. Ibuprofen Moment 200 200 mg Coated tablet Oral use Rua João Chagas, 53 - 3º 1499-040 Cruz Quebrada - Dafundo Portugal Portugal Laboratorio de Aplicaciones Ibuprofen NORVECTAN 400 400 mg Powder for oral Oral use Farmacodinamicas, S.A. suspension C/ Grassot, 16 08025 Barcelona Spain Portugal Laboratorio de Aplicaciones Ibuprofen NORVECTAN 600 600 mg Powder for oral Oral use Farmacodinamicas, S.A. suspension C/ Grassot, 16 08025 Barcelona Spain Portugal Distrifarma - Companhia de Ibuprofen Nolofene 200 mg Coated tablet Oral use Distribuição Farmacêutica, S.A. Estrada Consiglieri Pedroso, 80 - Lt. 3 - Armz. 1/12 - Queluz de Baixo 2745-553 Barcarena Portugal

235

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Reckitt Benckiser Ibuprofen Nurofen 40 mg/ml Oral suspension Oral use Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal Portugal Reckitt Benckiser Ibuprofen Nurofen 200 mg Coated tablet Oral use Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal Portugal Reckitt Benckiser Ibuprofen Nurofen 200 mg Capsule, soft Oral use Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal Portugal Reckitt Benckiser Ibuprofen Nurofen 400 400 mg Coated tablet Oral use Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal

236

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Reckitt Benckiser Ibuprofen Nurofen Della 400 mg Coated tablet Oral use Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal Portugal Reckitt Benckiser Ibuprofen Nurofen Zavance 400 mg Capsule, soft Oral use Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal Portugal Reckitt Benckiser Ibuprofen Nurofen Zavance 200 mg Coated tablet Oral use Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal Portugal Omega Pharma Portuguesa, Ibuprofen Ozonol 200 mg Coated tablet Oral use Unipessoal, Lda. Av. Tomás Ribeiro 43, Edifício Neopark, Bloco 1 - 3ºC 2790-221 Carnaxide Portugal

237

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Laboratórios Azevedos - Ibuprofen Solufen 20 mg/ml Oral suspension Oral use Indústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal Portugal Laboratórios Azevedos - Ibuprofen Solufen 200 mg Capsule, hard Oral use Indústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal Portugal Zambon - Produtos Ibuprofen Spidifen 200 mg Granules for oral Oral use Farmacêuticos, Lda. solution Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal Portugal Zambon - Produtos Ibuprofen Spidifen 600 mg Granules for oral Oral use Farmacêuticos, Lda. solution Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

238

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Zambon - Produtos Ibuprofen Spidifen 400 mg Granules for oral Oral use Farmacêuticos, Lda. solution Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal Portugal Zambon - Produtos Ibuprofen Spidifen 400 mg 400 mg Film-coated tablet Oral use Farmacêuticos, Lda. Comprimidos Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal Portugal Zambon - Produtos Ibuprofen Spidifen Limão 400 mg Granules for oral Oral use Farmacêuticos, Lda. solution Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal Portugal Generis Farmacêutica, S.A. Ibuprofen Tricalma 200 mg Coated tablet Oral use Rua João de Deus, 19 2700-487 Amadora Portugal

239

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Laboratório Medinfar - Ibuprofen Trifene 20 mg/ml Oral suspension Oral use Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal Portugal Medinfar Consumer Health - Ibuprofen Trifene 200 200 mg Film-coated tablet Oral use Produtos Farmacêuticos, Lda. Rua Henrique Paiva Couceiro, 27 - Venda Nova 2700-451 Amadora Portugal Portugal Laboratório Medinfar - Ibuprofen Trifene 400 400 mg Coated tablet Oral use Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal Portugal Laboratório Medinfar - Ibuprofen Trifene 400 400 mg Film-coated tablet Oral use Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal

240

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Laboratório Medinfar - Ibuprofen Trifene 600 600 mg Coated tablet Oral use Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal Portugal Medinfar Consumer Health - Ibuprofen Trifene Dispersível 200 mg Dispersible tablet Oral use Produtos Farmacêuticos, Lda. Rua Henrique Paiva Couceiro, 27 - Venda Nova 2700-451 Amadora Portugal Portugal Laboratório Medinfar - Ibuprofen Trifene Efervescente 200 mg Effervescent tablet Oral use Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal Portugal Labialfarma - Laboratório de Ibuprofen Zip-A-Dol 200 mg Capsule, hard Oral use Produtos Farmacêuticos e Nutracêuticos, S.A. Edifício Labialfarma, 1 - Felgueira 3450-336 Sobral - Mortágua Portugal

241

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Portugal Jaba Recordati, S. A. Dexibuprofen Seractil 200 mg Film-coated tablet Oral use Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal

Portugal Jaba Recordati, S. A. Dexibuprofen Seractil 300 mg Film-coated tablet Oral use Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal

Portugal Jaba Recordati, S. A. Dexibuprofen Seractil 400 mg Film-coated tablet Oral use Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal

Romania Actavis Group PTC ehf IBUPROFEN ADAGIN 200 mg 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Romania Actavis Group PTC ehf IBUPROFEN ADAGIN 400 mg 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

242

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Romania Pfizer Corporation Austria IBUPROFEN ADVIL 200 mg Coated tablet Oral use GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria Romania Pfizer Corporation Austria IBUPROFEN ADVIL ULTRA 400 mg Capsule, soft Oral use GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria Romania Zentiva, k.s. IBUPROFEN ALGIN BABY 100 mg/5 20 mg/ml Oral suspension Oral use U kabelovny 130 ml 102 37 Praha 10 Dolní Měcholupy Czech Republic Romania Abbott Scandinavia AB IBUPROFEN BRUFEN 20 mg/ml 20 mg/ml Oral suspension Oral use P.O Box 1498 SE-171 29 Solna Sweden Romania Abbott Scandinavia AB IBUPROFEN BRUFEN 400 mg 400 mg Film-coated tablet Oral use P.O Box 1498 SE-171 29 Solna Sweden Romania Abbott Scandinavia AB IBUPROFEN BRUFEN 400 mg 400 mg Effervescent granules Oral use P.O Box 1498 SE-171 29 Solna Sweden

243

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Romania Abbott Scandinavia AB IBUPROFEN BRUFEN RETARD 800 800 mg Prolonged-release Oral use P.O Box 1498 mg tablet SE-171 29 Solna Sweden Romania S.C. SOLACIUM PHARMA IBUPROFEN EFISEN M 200 mg 200 mg Film-coated tablet Oral use S.R.L. Calea Rahovei nr. 266-268, corp 63, anexele B-C, stâlpii 3-4, etaj 3, cam. 10, sector 5, București Romania Romania Zambon S.p.A. IBUPROFEN FASPIC 400 mg 400 mg Granules for oral Oral use Via Lillo del Duca 10 solution 20091, Bresso (Mi) Italy Romania Zambon S.p.A. IBUPROFEN FASPIC 600 600 mg Granules for oral Oral use Via Lillo del Duca 10 solution 20091, Bresso (Mi) Italy Romania Zambon S.p.A. IBUPROFEN FASPIC® 400 mg 400 mg Film-coated tablet Oral use Via Lillo del Duca 10 20091, Bresso (Mi) Italy Romania Zentiva, k.s. IBUPROFEN IBALGIN 200 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

244

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Romania Zentiva, k.s. IBUPROFEN IBALGIN FORTE 400 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Romania Zentiva, k.s. IBUPROFEN IBALGIN FORTE 400 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Romania Zentiva, k.s. IBUPROFEN IBALGIN RAPID 400 mg Film-coated tablet Oral use U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Romania S.C. ANTIBIOTICE S.A. IBUPROFEN IBUFEN 200 mg 200 mg Film-coated tablet Oral use Str. Valea Lupului nr.1, Iaşi Romania

Romania S.C. ARENA GROUP S.A. IBUPROFEN IBUPROFEN ARENA 200 200 mg Capsule, hard Oral use Str. Ştefan Mihăileanu mg nr.31, Sector 2, Bucureşti, România Romania S.C. ARENA GROUP S.A. IBUPROFEN IBUPROFEN ARENA 400 400 mg Capsule, hard Oral use Str. Ştefan Mihăileanu mg nr.31, Sector 2, Bucureşti, România

245

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Romania CIPLA (UK) LIMITED IBUPROFEN IBUPROFEN CIPLA 200 200 mg Film-coated tablet Oral use The Old Post House Heath Road, Surrey Weybridge KT13 8TS United Kingdom Romania CIPLA (UK) LIMITED IBUPROFEN IBUPROFEN CIPLA 400 400 mg Film-coated tablet Oral use The Old Post House Heath Road, Surrey Weybridge KT13 8TS United Kingdom Romania CIPLA (UK) LIMITED IBUPROFEN IBUPROFEN CIPLA 600 600 mg Film-coated tablet Oral use The Old Post House Heath Road, Surrey Weybridge KT13 8TS United Kingdom Romania Abbott Scandinavia AB IBUPROFEN ABFEN 200 mg/5 ml 40 mg/ml Oral suspension Oral use P.O Box 1498 suspensie orală SE-171 29 Solna Sweden Romania Berlin-Chemie AG IBUPROFEN MIG 40 mg/ ml 40 mg/ml Oral suspension Oral use Glienicker Weg 125 12489 Berlin Germany Romania Abbott Scandinavia AB IBUPROFEN ABFEN 200 mg 200 mg Effervescent granules Oral use P.O Box 1498 SE-171 29 Solna Sweden

246

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Romania Abbott Scandinavia AB IBUPROFEN BRUFEN 600 mg 600 mg Effervescent granules Oral use P.O Box 1498 SE-171 29 Solna Sweden Romania S.C. Sandoz S.R.L. IBUPROFEN IBUPROFEN SANDOZ 20 mg/ml Oral suspension Oral use Str. Livezeni, Nr. 7A 20 mg/ml 540472 Târgu Mureş Romania Romania S.C. Sandoz S.R.L. IBUPROFEN IBUPROFEN SANDOZ 40 mg/ml Oral suspension Oral use Str. Livezeni, Nr. 7A 40 mg/ml 540472 Târgu Mureş Romania Romania US Pharmacia Sp. z o.o. IBUPROFEN IBUPROM 200 mg Coated tablet Oral use Ziebicka st. 40 50-507 Wroclaw Poalnd Romania Alvogen IPCo S.àr.l. IBUPROFEN INFLANOR 200 mg 200 mg Capsule, soft Oral use Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg Romania Alvogen IPCo S.àr.l. IBUPROFEN INFLANOR FORTE 400 400 mg Capsule, soft Oral use Rue Heienhaff, 5 mg L-1736, Senningerberg Luxemburg

247

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Romania S.C. LAROPHARM S.R.L. IBUPROFEN LAROFEN 200 mg 200 mg Film-coated tablet Oral use Şoseaua Alexandriei nr. 145 A, Bragadiru, Ilfov Romania Romania GLAXOSMITHKLINE IBUPROFEN PANAFEN 200 mg 200 mg Capsule, hard Oral use CONSUMER HEALTHCARE S.R.L. Str. Costache Negri, Nr. 1-5 Opera Center One Etaj 6 (Zona 2), Sector 5 Bucureşti România Romania GLAXOSMITHKLINE IBUPROFEN PANAFEN 400 mg 400 mg Capsule, hard Oral use CONSUMER HEALTHCARE S.R.L. Str. Costache Negri, Nr. 1-5 Opera Center One Etaj 6 (Zona 2), Sector 5 Bucureşti România Romania Berlin-Chemie AG IBUPROFEN MIG-400 400 mg Film-coated tablet Oral use Glienicker Weg 125 12489 Berlin Germany

248

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Romania Reckitt Benckiser Healthcare IBUPROFEN NUROFEN EXPRESS 200 200 mg Capsule, soft Oral use International Limited mg Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Romania Reckitt Benckiser Healthcare IBUPROFEN NUROFEN EXPRESS 200 200 mg Capsule, soft Oral use International Limited mg Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Romania Reckitt Benckiser Healthcare IBUPROFEN NUROFEN EXPRESS 400 400 mg Oral powder Oral use International Limited mg Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Romania Reckitt Benckiser Healthcare IBUPROFEN NUROFEN EXPRESS 400 mg Capsule, soft Oral use International Limited FORTE 400 mg Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

249

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Romania Reckitt Benckiser Healthcare IBUPROFEN NUROFEN FORTE 400 mg Capsule, hard Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Romania Reckitt Benckiser Healthcare IBUPROFEN NUROFEN IMMEDIA 400 mg Capsule, hard Oral use International Limited ULTRA 400 mg Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Romania Reckitt Benckiser Healthcare IBUPROFEN NUROFEN® 200 mg 200 mg Capsule, hard Oral use International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Romania US Pharmacia Sp. z o.o. IBUPROFEN PADUDEN FORTE 400 400 mg Capsule, hard Oral use Ziebicka st. 40 mg 50-507 Wroclaw Poalnd Romania S.C. TERAPIA S.A. IBUPROFEN PADUDEN® 200 mg 200 mg Capsule, hard Oral use Str. Fabricii, nr. 124 Cluj-Napoca Romania

250

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Romania S.C. TERAPIA S.A. IBUPROFEN PADUDEN® SR 300 mg 300 mg Prolonged-release Oral use Str. Fabricii, nr. 124 capsule, hard Cluj-Napoca Romania Romania S.C. AC HELCOR S.R.L. IBUPROFEN REUPROFEN 200 mg 200 mg Film-coated tablet Oral use Str. Dr.Victor Babeş Nr. 50 Baia Mare Romania Romania S.C. AC HELCOR S.R.L. IBUPROFEN REUPROFEN 400 mg 400 mg Film-coated tablet Oral use Str. Dr.Victor Babeş Nr. 50 Baia Mare Romania Romania Medochemie Ltd IBUPROFEN RUPAN 200 mg 200 mg Film-coated tablet Oral use 1-10 Constantinoupoleos str Limassol 3505 Cyprus Romania Bayer S.R.L. IBUPROFEN SARIDON N 400 400 mg Film-coated tablet Oral use Şos. Pipera Nr. 42, Etajele 1, 16, 17 Sector 2, Bucureşti Romania Romania Zentiva, k.s. Ibuprofen MODAFEN 200 mg Film-coated tablet Oral use U kabelovny 130 pseudoephedrine 30 mg 102 37 Praha 10 Dolní Měcholupy Czech Republic

251

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Romania US Pharmacia Sp. z o.o. Ibuprofen IBUPROM SINUS 200 200 mg Coated tablet Oral use Ziebicka st. 40 pseudoephedrine mg/30 mg 30 mg 50-507 Wroclaw Poalnd Romania Boehringer Ingelheim Ibuprofen MUCOGRIP 200 mg/30 200 mg Film-coated tablet Oral use International GmbH pseudoephedrine mg 30 mg Binger Straße 173 55216 Ingelheim am Rhein Germany Romania Abbott Scandinavia AB Ibuprofen BRUFEN PLUS 400 mg/30 Film-coated tablet Oral use P.O Box 1498 pseudoephedrine mg SE-171 29 Solna Sweden Slovak Pfizer Corporation Austria Ibuprofen ADVIL RAPID 400 mg Capsule, soft Oral use Republic GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria Slovak BGP Products s.r.o. Ibuprofen Brufen 400 400 mg Film-coated tablet Oral use Republic Karadžičova 10 821 08 Bratislava Slovakia Slovak BGP Products s.r.o. Ibuprofen Brufedol 400 mg 400 mg Effervescent granules Oral use Republic Karadžičova 10 šumivý granulát 821 08 Bratislava Slovakia

252

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Slovak BGP Products s.r.o. Ibuprofen Brufen 600 600 mg Effervescent granules Oral use Republic Karadžičova 10 821 08 Bratislava Slovakia Slovak BGP Products s.r.o. Ibuprofen Brufen retard 800 800 mg Film-coated Oral use Republic Karadžičova 10 prolonged-release 821 08 Bratislava tablet Slovakia Slovak BGP Products s.r.o. Ibuprofen BRUFEN sirup 20 mg/ml Syrup Oral use Republic Karadžičova 10 821 08 Bratislava Slovakia Slovak Zentiva, k.s. Ibuprofen Ibalgin 200 200 mg Film-coated tablet Oral use Republic U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Slovak Zentiva, k.s. Ibuprofen Ibalgin 400 400 mg Film-coated tablet Oral use Republic U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Slovak Zentiva, k.s. Ibuprofen Ibalgin 600 600 mg Film-coated tablet Oral use Republic U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

253

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Slovak Zentiva, k.s. Ibuprofen IBALGIN FAST 400 mg Film-coated tablet Oral use Republic U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic Slovak Zentiva, k.s. Ibuprofen Ibalgin Grip 200 mg/5 Film-coated tablet Oral use Republic U kabelovny 130 phenylephrine mg 102 37 Praha 10 Dolní Měcholupy Czech Republic Slovak Actavis Group PTC ehf Ibuprofen Ibudolor 200 mg 200 mg Film-coated tablet Oral use Republic Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Slovak Actavis Group PTC ehf Ibuprofen Ibudolor 400 mg 400 mg Film-coated tablet Oral use Republic Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Slovak Generics UK Ibuprofen Ibumyl Rapid 200 mg 200 mg Film-coated tablet Oral use Republic Albany Gate Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

254

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Slovak Generics UK Ibuprofen Ibumyl Rapid 400 mg 400 mg Film-coated tablet Oral use Republic Albany Gate Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom Slovak STADA Arzneimittel AG Ibuprofen Ibuprofen 400 STADA 400 mg Film-coated tablet Oral use Republic Stadastr. 2-18 61118 Bad Vilbel Germany Slovak Dr. Max Pharma Ltd. Ibuprofen Ibuprofen Dr.Max 200 200 mg Film-coated tablet Oral use Republic First Floor Roxburge House, mg filmom obalené Regent Street 273-287 tablety W1B 2HA London United Kingdom Slovak Dr. Max Pharma Ltd. Ibuprofen Ibuprofen Dr.Max 400 400 mg Film-coated tablet Oral use Republic First Floor Roxburge House, mg filmom obalené Regent Street 273-287 tablety W1B 2HA London United Kingdom Slovak Galpharm Healthcare Ibuprofen Ibuprofen Galpharm 200 mg Coated tablet Oral use Republic Limited 200 mg obalené tablety Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

255

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Slovak Galpharm Healthcare Ibuprofen Ibuprofen Galpharm 400 mg Coated tablet Oral use Republic Limited 400 mg obalené tablety Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom Slovak BGP Products s.r.o. Ibuprofen Brufedol 200 mg 200 mg Effervescent granules Oral use Republic Karadžičova 10 šumivý granulát 821 08 Bratislava Slovakia Slovak Vitabalans Oy Ibuprofen Ibutabs 200 mg 200 mg Film-coated tablet Oral use Republic Varastokatu 8 13500 Hämeenlinna Finland Slovak Vitabalans Oy Ibuprofen Ibutabs 400 mg 400 mg Film-coated tablet Oral use Republic Varastokatu 8 13500 Hämeenlinna Finland Slovak Vitabalans Oy Ibuprofen Ibutabs 600 mg 600 mg Film-coated tablet Oral use Republic Varastokatu 8 13500 Hämeenlinna Finland Slovak Vitabalans Oy Ibuprofen Ibutabs 800 mg 800 mg Film-coated tablet Oral use Republic Varastokatu 8 13500 Hämeenlinna Finland

256

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Slovak Berlin-Chemie AG Ibuprofen MIG-400 400 mg Film-coated tablet Oral use Republic Glienicker Weg 125 12489 Berlin Germany Slovak Zentiva, k.s. Ibuprofen MODAFEN 200 mg Film-coated tablet Oral use Republic U kabelovny 130 pseudoephedrine 102 37 Praha 10 Dolní Měcholupy Czech Republic Slovak Reckitt Benckiser Healthcare Ibuprofen NUROFEN 200 mg 200 mg Coated tablet Oral use Republic International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Slovak Reckitt Benckiser Healthcare Ibuprofen NUROFEN 400 mg 400 mg Coated tablet Oral use Republic International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Slovak Reckitt Benckiser Healthcare Ibuprofen Nurofen Expres 200 mg 200 mg Coated tablet Oral use Republic International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

257

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Slovak Reckitt Benckiser Healthcare Ibuprofen Nurofen Expres 400 mg 400 mg Coated tablet Oral use Republic International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Slovak Reckitt Benckiser Healthcare Ibuprofen Nurofen Instant 400 mg 400 mg Oral powder Oral use Republic International Limited perorálny prášok Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Slovak Reckitt Benckiser Healthcare Ibuprofen Nurofen Rapid 200 mg 200 mg Capsule, soft Oral use Republic International Limited Capsules Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Slovak Reckitt Benckiser Healthcare Ibuprofen NUROFEN Rapid 400 400 mg Capsule, soft Oral use Republic International Limited mg Capsules Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

258

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Slovak Reckitt Benckiser Healthcare Ibuprofen NUROFEN STOPGRIP 200 mg Film-coated tablet Oral use Republic International Limited pseudoephedrine Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Slovenia KRKA d.d Ibuprofen Bonifen 200 mg filmsko 200 mg Film-coated tablet Oral use Šmarješka cesta 6 obložene tablete 8000 Novo mesto Slovenia Slovenia Abbott Laboratories d.o.o. Ibuprofen Brufen 20 mg/ml 20 mg/ml Oral suspension Oral use Dolenjska cesta 242c peroralna suspenzija 1000 Ljubljana Slovenia Slovenia Abbott Laboratories d.o.o. Ibuprofen Brufen 200 mg filmsko 200 mg Film-coated tablet Oral use Dolenjska cesta 242c obložene tablete 1000 Ljubljana Slovenia Slovenia Abbott Laboratories d.o.o. Ibuprofen Brufen 400 mg filmsko 400 mg Film-coated tablet Oral use Dolenjska cesta 242c obložene tablete 1000 Ljubljana Slovenia Slovenia Abbott Laboratories d.o.o. Ibuprofen Brufen 400 mg šumeča 400 mg Effervescent granules Oral use Dolenjska cesta 242c zrnca 1000 Ljubljana Slovenia

259

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Slovenia Abbott Laboratories d.o.o. Ibuprofen Brufen 600 mg filmsko 600 mg Film-coated tablet Oral use Dolenjska cesta 242c obložene tablete 1000 Ljubljana Slovenia Slovenia Abbott Laboratories d.o.o. Ibuprofen Brufen retard 800 mg 800 mg Prolonged-release Oral use Dolenjska cesta 242c tablete s podaljšanim tablet 1000 Ljubljana sproščanjem Slovenia Slovenia Abbott Laboratories d.o.o. Ibuprofen Brufen z okusom 40 mg/ml Oral suspension Oral use Dolenjska cesta 242c jagode 40 mg/ml 1000 Ljubljana peroralna suspenzija Slovenia Slovenia LEK d.d. Ibuprofen Diverin 400 mg filmsko 400 mg Film-coated tablet Oral use Verovškova 57 obložene tablete 1526 Ljubljana Slovenia Slovenia LEK d.d. Ibuprofen Diverin za otroke 40 40 mg/ml Oral suspension Oral use Verovškova 57 mg/ml peroralna 1526 Ljubljana suspenzija z okusom Slovenia jagode Slovenia Vitabalans Oy Ibuprofen Ibacut 200 mg filmsko 200 mg Film-coated tablet Oral use Varastokatu 8 obložene tablete 13500 Hämeenlinna Finland Slovenia Vitabalans Oy Ibuprofen Ibacut 400 mg filmsko 400 mg Film-coated tablet Oral use Varastokatu 8 obložene tablete 13500 Hämeenlinna Finland

260

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Slovenia sanofi-aventis d.o.o. Ibuprofen Ibalgin NEO 400 mg 400 mg Film-coated tablet Oral use Dunajska cesta 151 filmsko obložene 1000 Ljubljana tablete Slovenia Slovenia Belupo, d.o.o. Ibuprofen Ibubel 200 mg filmsko 200 mg Film-coated tablet Oral use Dvoržakova 6 obložene tablete 1000 Ljubljana Slovenia Slovenia Belupo, d.o.o. Ibuprofen Ibubel 400 mg filmsko 400 mg Film-coated tablet Oral use Dvoržakova 6 obložene tablete 1000 Ljubljana Slovenia Slovenia Belupo, d.o.o. Ibuprofen Ibuprofen Belupo 20 20 mg/ml Oral suspension Oral use Dvoržakova 6 mg/ml peroralna 1000 Ljubljana suspenzija Slovenia Slovenia Belupo, d.o.o. Ibuprofen IBUPROFEN BELUPO 400 mg Film-coated tablet Oral use Dvoržakova 6 400 mg filmsko 1000 Ljubljana obložene tablete Slovenia Slovenia Belupo, d.o.o. Ibuprofen IBUPROFEN BELUPO 600 mg Film-coated tablet Oral use Dvoržakova 6 600 mg filmsko 1000 Ljubljana obložene tablete Slovenia Slovenia Belupo, d.o.o. Ibuprofen IBUPROFEN BELUPO 800 mg Film-coated tablet Oral use Dvoržakova 6 800 mg filmsko 1000 Ljubljana obložene tablete Slovenia

261

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Slovenia Abbott Laboratories d.o.o. Ibuprofen Brufen Gran 200 mg 200 mg Effervescent granules Oral use Dolenjska cesta 242c šumeča zrnca 1000 Ljubljana Slovenia Slovenia Abbott Laboratories d.o.o. Ibuprofen Brufen 600 mg šumeča 600 mg Effervescent granules Oral use Dolenjska cesta 242c zrnca 1000 Ljubljana Slovenia Slovenia Vitabalans Oy Ibuprofen Ibuprofen Vitabalans 200 mg Film-coated tablet Oral use Varastokatu 8 200 mg filmsko 13500 Hämeenlinna obložene tablete Finland Slovenia Vitabalans Oy Ibuprofen Ibuprofen Vitabalans 400 mg Film-coated tablet Oral use Varastokatu 8 400 mg filmsko 13500 Hämeenlinna obložene tablete Finland Slovenia Vitabalans Oy Ibuprofen Ibuprofen Vitabalans 600 mg Film-coated tablet Oral use Varastokatu 8 600 mg filmsko 13500 Hämeenlinna obložene tablete Finland Slovenia Vitabalans Oy Ibuprofen Ibuprofen Vitabalans 800 mg Film-coated tablet Oral use Varastokatu 8 800 mg filmsko 13500 Hämeenlinna obložene tablete Finland

262

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Slovenia Reckitt Benckiser Healthcare Ibuprofen Nurofen 200 mg 200 mg Film-coated tablet Oral use International Limited obložene tablete Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Slovenia Reckitt Benckiser Healthcare Ibuprofen Nurofen Immedia 200 200 mg Capsule, soft Oral use International Limited mg mehke kapsule Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom Spain ISDIN, S.A. Ibuprofen ALGIASDIN 600 mg 600 mg Film-coated tablet Oral use Provençals, 33 comprimidos 08019 Barcelona recubiertos con película Spain Spain ISDIN, S.A. Ibuprofen ALGIASDIN RETARD 600 mg Coated tablet Oral use Provençals, 33 600 mg comprimidos 08019 Barcelona recubiertos de Spain liberación prolongada Spain Abbott Laboratories, S.A. Ibuprofen DALSY 400 mg 400 mg Film-coated tablet Oral use Avda. de Burgos, 91 comprimidos 28050 Madrid recubiertos con película Spain

263

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain Johnson and Johnson, S.A. Ibuprofen DOCTRIL 400 FORTE 400 mg Coated tablet Oral use Pº de las 12 Estrellas, 5-7 BLISTER Campo de las Naciones 28042 Madrid Spain Spain ZAMBON, S.A. Ibuprofen ESPIDIDOL 400 mg 400 mg Coated tablet Oral use Maresme, 5 comprimidos Polígono Can Bernardes- recubiertos Subirá 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain Spain ZAMBON, S.A. Ibuprofen arginine ESPIDIFEN 400 mg 400 mg Coated tablet Oral use Maresme, 5 comprimidos Polígono Can Bernardes- recubiertos Subirá 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain Spain Ferrer Internacional, S.A. Ibuprofen GELOFENO 200 mg 200 mg Tablet Oral use Gran Vía Carlos III, 94 comprimidos 08028 Barcelona Spain Spain Ferrer Internacional, S.A. Ibuprofen GELOFENO 400 mg 400 mg Tablet Oral use Gran Vía Carlos III, 94 comprimidos 08028 Barcelona Spain

264

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain Ferrer Internacional, S.A. Ibuprofen GELOFENO 600 mg 400 mg Tablet Oral use Gran Vía Carlos III, 94 comprimidos 08028 Barcelona Spain Spain LABORATORIOS CINFA, S.A. Ibuprofen IBUFEN 400 mg 400 mg Film-coated tablet Oral use Olaz-Chipi, 10 comprimidos Polígono Industrial Areta recubiertos con película 31620 Huarte-Pamplona (Navarra) Spain Spain TEVA PHARMA, S.L.U. Ibuprofen IBUMAC 600 mg 600 mg Film-coated tablet Oral use Anabel Segura, 11 comprimidos Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain Spain KERN PHARMA, S.L. Ibuprofen IBUKERN 400 mg 400 mg Film-coated tablet Oral use Venus, 72. Poligono comprimidos Industrial Colon II. Tarrasa recubiertos con película (Barcelona) 08228 EFG Spain Spain KERN PHARMA, S.L. Ibuprofen IBUKERN 600 mg 600 mg Film-coated tablet Oral use Venus, 72. Poligono comprimidos Industrial Colon II. Tarrasa recubiertos con película (Barcelona) 08228 EFG Spain

265

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain Bexal Farmaceutica, S.A. Ibuprofen IBUPROFENO ACOST 600 mg Film-coated tablet Oral use Centro Empresarial Osa 600 mg comprimidos Mayor recubiertos con película Avda. Osa Mayor, 4 - Area B EFG 28023 Aravaca (Madrid) Spain Spain Aurovitas Spain, S.A.U. Ibuprofen IBUPROFENO ACTAVIS 600 mg Film-coated tablet Oral use Avda. de Burgos, 16-D 600 mg comprimidos 28036 Madrid recubiertos con película Spain EFG Spain ALMUS FARMACEUTICA, Ibuprofen IBUPROFENO ALMUS 600 mg Film-coated tablet Oral use S.A. 600 mg comprimidos Avda. Verge de Montserrat, recubiertos con película 6 EFG 08820 El Prat de Llobregat (Barcelona) Spain Spain APOTEX EUROPE B.V Ibuprofen IBUPROFENO APOTEX 600 mg Film-coated tablet Oral use Darwinweb, 20 600 mg comprimidos 2333-CR Leiden recubiertos con película Netherlands EFG Spain LABORATORIOS COMBIX, Ibuprofen IBUPROFENO PHARMA 600 mg Film-coated tablet Oral use S.L.U. COMBIX 600 mg Badajoz, 2, Edificio 2 comprimidos 28223 Pozuelo de Alarcón recubiertos con película (Madrid) EFG Spain

266

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain LABORATORIOS CINFA, S.A. Ibuprofen IBUPROFENO CINFA 600 mg Film-coated tablet Oral use Olaz-Chipi, 10 600 mg comprimidos Polígono Industrial Areta recubiertos con película 31620 Huarte-Pamplona EFG (Navarra) Spain Spain GENERICOS, S.L. Ibuprofen IBUPROFENO STADA 400 mg Film-coated tablet Oral use Frederic Mompou, 5 GENÉRICOS 400 mg 08960 Sant Just Desvern comprimidos (Barcelona) recubiertos con película Spain EFG Spain LABORATORIOS COMBIX, Ibuprofen IBUPROFENO COMBIX 600 mg Film-coated tablet Oral use S.L.U. 600 mg comprimidos Badajoz, 2, Edificio 2 recubiertos con película 28223 Pozuelo de Alarcón EFG (Madrid) Spain Spain LABORATORIOS DAVUR, Ibuprofen IBUPROFENO DAVUR 600 mg Film-coated tablet Oral use S.L. 600 mg comprimidos Teide, 4-planta baja. recubiertos con película Poligono Empresarial La EFG Marina, San Sebastián de los Reyes (Madrid) 28703 Spain

267

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain DERMOGEN FARMA, S.A. Ibuprofen IBUPROFENO 400 mg Film-coated tablet Oral use San Rafael, 3 DERMOGEN 400 mg 28108 Alcobendas (Madrid) comprimidos Spain recubiertos Spain DERMOGEN FARMA, S.A. Ibuprofen IBUPROFENO 400 mg Film-coated tablet Oral use San Rafael, 3 DERMOGENERIS 400 28108 Alcobendas (Madrid) mg comprimidos Spain recubiertos con película EFG Spain LABORATORIOS FRANCISCO Ibuprofen IBUPROFENO DURBAN 400 mg Tablet Oral use DURBAN, S.A. 400 mg comprimidos Calle IX nº 75-76 Polígono Industrial La Redonda 04710 El Ejido (Almería) Spain Spain MABO-FARMA, S.A. Ibuprofen IBUPROFENO ABDRUG 600 mg Film-coated tablet Oral use Carretera M-300 Km 30,500 600 m comprimidos 28802 Alcalá de Henares recubiertos con película (Madrid) EFG Spain Spain Farmalider S.A. Ibuprofen IBUPROFENO 400 mg Film-coated tablet Oral use C/ Aragoneses, 15 LIDERFARM 600 mg Alcobendas (Madrid), 28108 comprimidos Spain recubiertos con película EFG

268

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain STADA GENÉRICOS, S.L. Ibuprofen IBUPROFENO STADA 600 mg Film-coated tablet Oral use Frederic Mompou, 5 GENÉRICOS 600 mg 08960 Sant Just Desvern comprimidos (Barcelona) Spain recubiertos con película EFG Spain LABORATORIOS ALTER, S.A. Ibuprofen IBUPROFENO 600 mg Film-coated tablet Oral use Mateo Inurria, 30 FARMALTER 600 mg 28036 Madrid comprimidos Spain recubiertos con película EFG Spain LABORATORIOS GAYOSO, Ibuprofen IBUPROFENO GAYOSO 400 mg Orodispersible tablet Oral use S.L. 400 mg comprimidos Hierro, 79 bucodispersables 28850 Torrejón de Árdoz (Madrid) Spain Spain Genericos Juventus Limited Ibuprofen IBUPROFENO 600 mg Film-coated tablet Oral use Julian Camarillo, 37 GENÉRICOS JUVENTUS 28037 Madrid 600 mg comprimidos Spain recubiertos con película EFG Spain LABORATORIOS CINFA, S.A. Ibuprofen IBUPROFENO GOIBELA 600 mg Film-coated tablet Oral use Olaz-Chipi, 10 600 mg comprimidos Polígono Industrial Areta recubiertos con película 31620 Huarte-Pamplona EFG (Navarra) Spain

269

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain KERN PHARMA, S.L. Ibuprofen IBUPROFENO KERN 400 mg Coated tablet Oral use Venus, 72. Poligono PHARMA 400 mg Industrial Colon II. Tarrasa comprimidos EFG (Barcelona) 08228 Spain Spain KERN PHARMA, S.L. Ibuprofen IBUPROFENO KERN 600 mg Coated tablet Oral use Venus, 72. Poligono PHARMA 600 mg Industrial Colon II. Tarrasa comprimidos EFG (Barcelona) 08228 Spain Spain Korhispana, S.L. Ibuprofen IBUPROFENO 600 mg Film-coated tablet Oral use Carretera de Castellvell, 24 KORHISPANA 600 mg 43206 Reus (Tarragona) comprimidos Spain recubiertos con película EFG Spain LABORATORIOS LLORENS, Ibuprofen IBUPROFENO LLORENS 600 mg Film-coated tablet Oral use S.A 600 mg comprimdos Ciudad de Balaguer, 7-11 recubiertos EFG 08022 Barcelona Spain Spain MABO FARMA, S.A. Ibuprofen IBUPROFENO MABO 600 mg Film-coated tablet Oral use Carretera M-300, Km. 600 mg comprimidos 30,500 recubiertos con película 28802 Alcalá de Henares EFG (Madrid) Spain

270

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain MYLAN PHARMACEUTICALS, Ibuprofen IBUPROFENO MYLAN 600 MG Coated tablet Oral use S.L. 600 mg comprimdos Plom 2-4, recubiertos EFG 5º planta 08038 Barcelona Spain Spain MYLAN PHARMACEUTICALS, Ibuprofen IBUPROFENO MYLAN 600 mg Film-coated tablet Oral use S.L. PHARMACEUTICALS Plom 2-4, 600 mg comprimidos 5º planta recubiertos con película 08038 Barcelona EFG Spain Spain LABORATORIOS NORMON, Ibuprofen IBUPROFENO NORMON 400 mg Film-coated tablet Oral use S.A. 400 mg comprimidos Ronda de Valdecarrizo, 6 recubiertos con película 28760 Tres Cantos (Madrid) EFG Spain Spain LABORATORIOS NORMON, Ibuprofen IBUPROFENO NORMON 600 mg Film-coated tablet Oral use S.A. 600 mg comprimidos Ronda de Valdecarrizo, 6 recubiertos con película 28760 Tres Cantos (Madrid) EFG Spain Spain ONEDOSE PHARMA, S.L. Ibuprofen IBUPROFENO ONEDOSE 600 mg Film-coated tablet Oral use Ca l'Alegre de Dalt, 28-30 600 mg comprimidos 08024 Barcelona recubiertos con película Spain EFG

271

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain LABORATORIOS CINFA, S.A. Ibuprofen IBUPROFENO OSODENT 600 mg Film-coated tablet Oral use Olaz-Chipi, 10 600 mg comprimidos Polígono Industrial Areta recubiertos con película 31620 Huarte-Pamplona EFG (Navarra) Spain Spain PENSA PHARMA, S.A.U. Ibuprofen IBUPROFENO PENSA 400 mg Film-coated tablet Oral use Jorge Comín (médico 400 mg comprimidos pediatra), 3 recubiertos con película 46015 Valencia EFG Spain Spain PENSA PHARMA, S.A.U. Ibuprofen IBUPROFENO PENSA 600 mg Film-coated tablet Oral use Jorge Comín (médico 600 mg comprimidos pediatra), 3 recubiertos con película 46015 Valencia EFG Spain Spain PENSA PHARMA, S.A.U. Ibuprofen IBUPROFENO PENSA 600 mg Film-coated tablet Oral use Jorge Comín (médico PHARMA 600 mg pediatra), 3 comrpimidos 46015 Valencia recubiertos con película Spain EFG Spain LABORATORIOS RANBAXY, Ibuprofen IBUPROFENO RANBAXY 600 mg Coated tablet Oral use S.L. 600 mg comprimidos Passeig de Gracia, 9 recubiertos EFG 08007 Barcelona Spain

272

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain RATIOPHARM ESPAÑA, S.A. Ibuprofen IBUPROFENO 600 mg Film-coated tablet Oral use Avda. de Burgos, 16 D-5ª RATIOPHARM 600 mg planta comprimidos 28036 Madrid recubiertos con película Spain EFG Spain SANDOZ FARMACÉUTICA, Ibuprofen IBUPROFENO SANDOZ 600 mg Film-coated tablet Oral use S.A. 600 mg comprimidos Avda. Osa Mayor recubiertos con película 28023 Aravaca (Madrid) EFG Spain Spain SMART PHARMA Ibuprofen IBUPROFENO SMART 600 mg Coated tablet Oral use Andrés Mellado, 76 600 mg comprimidos 28015 Madrid recubiertos EFG Spain Spain LABORATORIO STADA, S.A. Ibuprofen IBUPROFENO STADA 600 mg Film-coated tablet Oral use Frederic Mompou, 5 600 mg comprimidos 08960 Sant Just Desvern recubiertos con película (Barcelona) EFG Spain Spain STADA GENERICOS, S.L. Ibuprofen IBUPROFENO 400 mg Coated tablet Oral use Frederic Mompou, 5 STADAGEN 400 mg 08960 Sant Just Desvern comprimidos (Barcelona) recubiertos EFG Spain

273

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain STADA GENERICOS, S.L. Ibuprofen IBUPROFENO 600 mg Coated tablet Oral use Frederic Mompou, 5 STADAGEN 600 mg 08960 Sant Just Desvern comprimidos (Barcelona) recubiertos EFG Spain Spain TARBIS FARMA, S.L. Ibuprofen IBUPROFENO TARBIS 600 mg Film-coated tablet Oral use Gran Via Carlos III, 94 600 mg comprimidos Barcelona, 08028 recubiertos con película Spain EFG Spain TEVA PHARMA, S.L.U. Ibuprofen IBUPROFENO TEVA 400 400 mg Film-coated tablet Oral use Anabel Segura, 11 mg comprimidos Edificio Albatros B, 1ª planta recubiertos con película 28108 Alcobendas (Madrid) EFG Spain Spain TEVA PHARMA, S.L.U. Ibuprofen IBUPROFENO TEVA 600 600 mg Film-coated tablet Oral use Anabel Segura, 11 mg comprimidos Edificio Albatros B, 1ª planta recubiertos con película 28108 Alcobendas (Madrid) EFG Spain Spain Aristo Pharma Iberia, S.L. Ibuprofen IBUPROFENO ARISTO 600 mg Film-coated tablet Oral use Solana, 26 600 mg comprimidos 28850 Torrejón de Ardoz recubiertos con película (Madrid) EFG Spain

274

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain Zentiva, k.s. Ibuprofen IBUPROFENO ZENTIVA 400 mg Film-coated tablet Oral use U kabelovny 130 400 mg comprimidos 102 37 Praha 10 recubiertos con película Dolní Měcholupy EFG Czech Republic Spain Zentiva, k.s. Ibuprofen IBUPROFENO ZENTIVA 600 mg Film-coated tablet Oral use U kabelovny 130 600 mg comprimidos 102 37 Praha 10 recubiertos con película Dolní Měcholupy EFG Czech Republic Spain Reckitt Benckiser Healthcare Ibuprofen JUNIFEN 200 mg 200 mg Orodispersible tablet Oral use S.A. comprimidos Mataró, 28. bucodispersables sabor Granollers (Barcelona), limón 08403 Spain Spain Farmalider S.A. Ibuprofen LIDERFEME 400 mg 400 mg Film-coated tablet Oral use C/ Aragoneses, 15 comprimidos Alcobendas (Madrid), 28108 Spain Spain Abbott Laboratories, S.A. Ibuprofen NEOBRUFEN 400 mg 400 mg Film-coated tablet Oral use Avda. de Burgos, 91 comprimidos 28050 Madrid recubiertos con película Spain EFG Spain Abbott Laboratories, S.A. Ibuprofen NEOBRUFEN 600 mg 600 mg Film-coated tablet Oral use Avda. de Burgos, 91 comprimidos 28050 Madrid recubiertos con película Spain EFG

275

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain Abbott Laboratories, S.A. Ibuprofen NEOBRUFEN RETARD 800 mg Coated tablet Oral use Avda. de Burgos, 91 800 mg comprimidos 28050 Madrid de liberación Spain prolongada Spain Reckitt Benckiser Healthcare Ibuprofen sodium NUROFEN FAST 400 mg Coated tablet Oral use S.A. (SODIO) 400 mg Mataró, 28. comprimidos Granollers (Barcelona), recubiertos 08403 Spain Spain Reckitt Benckiser Healthcare Ibuprofen NUROFEN 400 mg 400 mg Film-coated tablet Oral use S.A. comprimidos Mataró, 28. recubiertos Granollers (Barcelona), 08403 Spain Spain ASTREL PHARMA, S.L. Ibuprofen IBUPROFENO ASTREL 400 mg Orodispersible tablet Oral use Vía de las dos Castillas 9C, 400 mg comprimidos portal 2 -3ºC bucodispersables 28224 Madrid Spain Spain Angelini Farmaceutica, S.A. Ibuprofen TODALGIL 400 mg 400 mg Film-coated tablet Oral use Osi 7-9 comprimidos Barcelona 08034 recubiertos con película Spain

276

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain ONEDOSE PHARMA, S.L. Ibuprofen UNODOL 400 mg 400 mg Film-coated tablet Oral use Ca l'Alegre de Dalt, 28-30 comprimidos 08024 Barcelona recubiertos con película Spain EFG Spain LABORATORIOS ERN, S.A. Ibuprofen APIROFENO 40 mg/ml 40 mg/ml Oral suspension Oral use Pedro IV, 499 SUSPENSION ORAL Barcelona 08020 Spain Spain Angelini Farmaceutica, S.A. Ibuprofen DADOSEL 20 mg/ml 20 mg/ml Oral suspension Oral use Osi 7-9 SUSPENSIÓN ORAL Barcelona 08034 Spain Spain Abbott Laboratories, S.A. Ibuprofen DALSY 40 mg/ml 40 mg/ml Oral suspension Oral use Avda. de Burgos, 91 SUSPENSION ORAL 28050 Madrid Spain Spain Farmalider S.A. Ibuprofen IBUFARMALID 200 mg 200 mg Oral suspension Oral use C/ Aragoneses, 15 SUSPENSION ORAL Alcobendas (Madrid), 28108 Spain Spain Farmalider S.A. Ibuprofen IBUFARMALID 400 mg 400 mg Oral suspension Oral use C/ Aragoneses, 15 SUSPENSION ORAL Alcobendas (Madrid), 28108 Spain Spain Farmalider S.A. Ibuprofen IBUFARMALID 600 mg 600 mg Oral suspension Oral use C/ Aragoneses, 15 SUSPENSION ORAL Alcobendas (Madrid), 28108 Spain

277

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain KERN PHARMA, S.L. Ibuprofen IBUKERN 200 MG 200 mg Oral suspension Oral use Venus, 72. Poligono SUSPENSIÓN ORAL Industrial Colon II. Tarrasa (Barcelona) 08228 Spain Spain KERN PHARMA, S.L. Ibuprofen IBUKERN 400 MG 400 mg Oral suspension Oral use Venus, 72. Poligono SUSPENSION ORAL Industrial Colon II. Tarrasa (Barcelona) 08228 Spain Spain KERN PHARMA, S.L. Ibuprofen IBUKERN 600 MG 600 mg Oral suspension Oral use Venus, 72. Poligono SUSPENSION ORAL Industrial Colon II. Tarrasa (Barcelona) 08228 Spain Spain Laboratorio Aldo Union, S.A. Ibuprofen IBUPROFENO ALDO- 20 mg/ml Oral suspension Oral use Baronesa de Malda, 73 UNIÓN 20 mg/ml Esplugues de Llobregat SUSPENSIÓN ORAL EFG Barcelona 08950 Spain Spain LABORATORIOS CINFA, S.A. Ibuprofen IBUPROFENO CINFA 20 mg/ml Oral suspensio n Oral use Olaz-Chipi, 10 100 mg/ 5 ml Polígono Industrial Areta SUSPENSION ORAL EFG 31620 Huarte-Pamplona (Navarra) Spain

278

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain LABORATORIOS CINFA, S.A. Ibuprofen IBUPROFENO CINFA 40 40 mg/ml Oral suspension Oral use Olaz-Chipi, 10 MG/ML SUSPENSION Polígono Industrial Areta ORAL EFG 31620 Huarte-Pamplona (Navarra) Spain Spain Farmalider S.A. Ibuprofen IBUPROFENO 20 mg/ml Oral suspension Oral use C/ Aragoneses, 15 CODRAMOL 20 mg / ml Alcobendas (Madrid), 28108 SUSPENSION ORAL EFG Spain Spain LABORATORIOS DAVUR, Ibuprofen IBUPROFENO DAVUR 20 mg/ml Oral suspension Oral use S.L. 20 mg/ ml Teide, 4-planta baja. SUSPENSIÓN ORAL EFG Poligono Empresarial La Marina, San Sebastián de los Reyes (Madrid) 28703 Spain Spain DERMOGEN FARMA, S.A. Ibuprofen IBUPROFENO 400 mg Oral suspension Oral use San Rafael, 3 DERMOGEN 400 mg 28108 Alcobendas (Madrid) SUSPENSION ORAL Spain Spain Farmalider S.A. Ibuprofen IBUPROFENO 20 mg/ml Oral suspension Oral use C/ Aragoneses, 15 FARMALID 20 mg/ml Alcobendas (Madrid), 28108 SUSPENSION ORAL EFG Spain

279

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain FARMASIERRA Ibuprofen IBUPROFENO 20 mg/ml Oral suspension Oral use LABORATORIOS, S.L. Ctra. FARMASIERRA 20 Irún, km.26,200 mg/ml SUSPENSION San Sebastián de los Reyes ORAL (Madrid) 28700 Spain Spain KERN PHARMA, S.L. Ibuprofen IBUPROFENO KERN 40 mg/ml Oral suspension Oral use Venus, 72. Poligono PHARMA 40 MG/ML Industrial Colon II. Tarrasa SUSPENSION ORAL EFG (Barcelona) 08228 Spain Spain LABORATORIOS NORMON, Ibuprofen IBUPROFENO NORMON 40 mg/ml Oral suspension Oral use S.A. 40 mg/ml SUSPENSION Ronda de Valdecarrizo, 6 ORAL EFG Tres Cantos (Madrid), 28670 Spain Spain SANDOZ FARMACÉUTICA, Ibuprofen IBUPROFENO SANDOZ 20 mg/ml Oral suspension Oral use S.A. 100 mg/5 ml Avda. Osa Mayor SUSPENSION ORAL 28023 Aravaca (Madrid) Spain Spain SANDOZ FARMACÉUTICA, Ibuprofen IBUPROFENO SANDOZ 40 mg/ml Oral suspension Oral use S.A. 40 mg/ml SUSPENSION Avda. Osa Mayor ORAL 28023 Aravaca (Madrid) Spain

280

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain Reckitt Benckiser Healthcare Ibuprofen JUNIFEN 40 mg/ml 40 mg/ml Oral suspension Oral use S.A. SUSPENSION ORAL Mataró, 28. SABOR FRESA EFG Granollers (Barcelona), 08403 Spain Spain DERMOGEN FARMA, S.A. Ibuprofen LEVEDOL 100 mg/5 ml 20 mg/ml Oral suspension Oral use San Rafael, 3 SUSPENSION ORAL 28108 Alcobendas (Madrid) Spain Spain Farmalider S.A. Ibuprofen LIDERFEME 400 mg 400 mg Oral suspension Oral use C/ Aragoneses, 15 SUSPENSION ORAL Alcobendas (Madrid), 28108 Spain Spain ITALFARMACO Ibuprofen IBLASIN 20mg/ml 20 mg/ml Oral suspension Oral use San Rafael, 3 SUSPENSION ORAL 28108 Alcobendas (Madrid) Spain Spain ITALFARMACO Ibuprofen IBLASIN 40 mg/ml 40 mg/ml Oral suspension Oral use San Rafael, 3 SUSPENSION ORAL 28108 Alcobendas (Madrid) Spain Spain Reckitt Benckiser Healthcare Ibuprofen NUROFEN 40 MG/ML 40 mg/ml Oral suspension Oral use S.A. SUSPENSION ORAL Mataró, 28. Granollers (Barcelona), 08403 Spain

281

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain Laboratorio Aldo Union, S.A. Ibuprofen PAIDOFEBRIL 20 mg/ml 20 mg/ml Oral suspension Oral use Baronesa de Malda, 73 SUSPENSIÓN ORAL Esplugues de Llobregat Barcelona 08950 Spain Spain LABORATORIOS JUVENTUS, Ibuprofen PIREXIN 40 mg/ml 40 mg/ml Oral suspension Oral use S.A. SUSPENSION ORAL Julián Camarillo, 37 Madrid, 28037 Spain Spain RATIOPHARM ESPAÑA, S.A. Ibuprofen RATIODOL 20 mg/ ml 20 mg/ml Oral suspension Oral use Avda. de Burgos, 16 D-5ª SUSPENSION ORAL planta 28036 Madrid Spain Spain FARDI, S.A. (APLICACIONES Ibuprofen lysinate ALGIDRIN 600 POLVO 600 mg Powder for oral Oral use FARMACODINAMICAS) PARA SUSPENSION suspension Grassot, 16 ORAL Barcelona, 08025 Spain Spain FARDI, S.A. (APLICACIONES Ibuprofen lysinate ALGIFAST 400 mg 400 mg Powder for oral Oral use FARMACODINAMICAS) POLVO PARA suspension Grassot, 16 SUSPENSION ORAL Barcelona, 08025 Spain

282

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain FARDI, S.A. (APLICACIONES Ibuprofen lysinate ALOGESIA 600 POLVO 600 mg Powder for oral Oral use FARMACODINAMICAS) PARA SUSPENSION suspension Grassot, 16 ORAL Barcelona, 08025 Spain Spain FARDI, S.A. (APLICACIONES Ibuprofen lysinate DOLORAC 600 mg 600 mg Powder for oral Oral use FARMACODINAMICAS) POLVO PARA suspension Grassot, 16 SUSPENSION ORAL Barcelona, 08025 Spain Spain FARDI, S.A. (APLICACIONES Ibuprofen lysinate NORVECTAN 600 600 mg Powder for oral Oral use FARMACODINAMICAS) POLVO PARA suspension Grassot, 16 SUSPENSION ORAL Barcelona, 08025 Spain Spain PHARMADIET, S.L.U. Ibuprofen lysinate FENOSPIN 400 mg 400 mg Powder for oral Oral use C/ Blanquers, 85 POLVO PARA solution Banyoles, 17820 SOLUCION ORAL Spain Spain Reckitt Benckiser Healthcare Ibuprofen lysinate NUROFEN FAST 400 mg Powder for oral Oral use S.A. (LISINA) 400 MG solution Mataró, 28. POLVO PARA Granollers (Barcelona), SOLUCION ORAL 08403 Spain

283

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain Abbott Laboratories, S.A. Ibuprofen DALSY 200 mg 200 mg Effervescent granules Oral use Avda. de Burgos, 91 GRANULADO 28050 Madrid EFERVESCENTE Spain Spain Abbott Laboratories, S.A. Ibuprofen DALSY 400 MG 400 mg Effervescent granules Oral use Avda. de Burgos, 91 GRANULADO 28050 Madrid EFERVESCENTE Spain Spain Abbott Laboratories, S.A. Ibuprofen IBUPROFENO ABBOTT 600 mg Effervescent granules Oral use Avda. de Burgos, 91 600 GRANULADO 28050 Madrid EFERVESCENTE EFG Spain Spain KERN PHARMA, S.L. Ibuprofen IBUKERN 600 MG 600 mg Effervescent granules Oral use Venus, 72. Poligono GRANULADO Industrial Colon II. Tarrasa EFERVESCENTE EFG (Barcelona) 08228 Spain Spain KERN PHARMA, S.L. Ibuprofen IBUPROFENO KERN 200 mg Effervescent granules Oral use Venus, 72. Poligono PHARMA 200 mg Industrial Colon II. Tarrasa GRANULADO (Barcelona) 08228 EFERVESCENTE EFG Spain Spain KERN PHARMA, S.L. Ibuprofen IBUPROFENO KERN 600 mg Effervescent granules Oral use Venus, 72. Poligono PHARMA 600 mg Industrial Colon II. Tarrasa GRANULADO (Barcelona) 08228 EFERVESCENTE EFG Spain

284

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain PENSA PHARMA, S.A.U. Ibuprofen IBUPROFENO PENSA 600 mg Effervescent granules Oral use Jorge Comín (médico 600 mg GRANULADO pediatra), 3 EFERVESCENTE EFG 46015 Valencia Spain Spain Abbott Laboratories, S.A. Ibuprofen NEOBRUFEN 600 mg 600 mg Effervescent granules Oral use Avda. de Burgos, 91 GRANULADO 28050 Madrid EFERVESCENTE Spain Spain ZAMBON, S.A. Ibuprofen arginine ESPIDIDOL 400 mg 400 mg Granules for oral Oral use Maresme, 5 GRANULADO PARA solution Polígono Can Bernardes- SOLUCION ORAL Subirá SABOR LIMON 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain Spain ZAMBON, S.A. Ibuprofen arginine ESPIDIDOL 400 mg 400 mg Granules for oral Oral use Maresme, 5 GRANULADO PARA solution Polígono Can Bernardes- SOLUCION ORAL Subirá SABOR MENTA 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

285

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain ZAMBON, S.A. Ibuprofen arginine ESPIDIFEN 400 mg 400 mg Granules for oral Oral use Maresme, 5 GRANULADO PARA solution Polígono Can Bernardes- SOLUCION ORAL Subirá SABOR MENTA 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain Spain ZAMBON, S.A. Ibuprofen arginine ESPIDIFEN 600 mg 600 mg Granules for oral Oral use Maresme, 5 GRANULADO PARA solution Polígono Can Bernardes- SOLUCION ORAL Subirá SABOR ALBARICOQUE 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain Spain ZAMBON, S.A. Ibuprofen arginine ESPIDIFEN 600 mg 600 mg Granules for oral Oral use Maresme, 5 GRANULADO PARA solution Polígono Can Bernardes- SOLUCION ORAL Subirá SABOR MENTA EFG 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain Spain Farmalider S.A. Ibuprofen arginine FEBRIROL 200 MG 200 mg Granules for oral Oral use C/ Aragoneses, 15 GRANULADO PARA solution Alcobendas (Madrid), 28108 SOLUCION ORAL Spain

286

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain LABORATORIOS CINFA, S.A. Ibuprofen arginine IBUPROFENO 400 mg Granules for oral Oral use Olaz-Chipi, 10 (ARGININA) CINFA 400 solution Polígono Industrial Areta mg GRANULADO PARA 31620 Huarte-Pamplona SOLUCION ORAL EFG (Navarra) Spain Spain LABORATORIOS CINFA, S.A. Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use Olaz-Chipi, 10 (ARGININA) CINFA 600 solution Polígono Industrial Areta mg GRANULADO PARA 31620 Huarte-Pamplona SOLUCION ORAL EFG (Navarra) Spain Spain LABORATORIOS CINFA, S.A. Ibuprofen arginine IBUPROFENO 400 mg Granules for oral Oral use Olaz-Chipi, 10 (ARGININA) CINFAMED solution Polígono Industrial Areta 400 mg GRANULADO 31620 Huarte-Pamplona PARA SOLUCION ORAL (Navarra) EFG Spain Spain LABORATORIOS CINFA, S.A. Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use Olaz-Chipi, 10 (ARGININA) CINFAMED solution Polígono Industrial Areta 600 mg GRANULADO 31620 Huarte-Pamplona PARA SOLUCION ORAL (Navarra) EFG Spain

287

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain Farmalider S.A. Ibuprofen arginine IBUPROFENO 400 mg Granules for oral Oral use C/ Aragoneses, 15 (ARGININA) solution Alcobendas (Madrid), 28108 CODRAMOL 400 mg Spain GRANULADO PARA SOLUCION ORAL EFG Spain Farmalider S.A. Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use C/ Aragoneses, 15 (ARGININA) solution Alcobendas (Madrid), 28108 CODRAMOL 600 mg Spain GRANULADO PARA SOLUCION ORAL EFG Spain LABORATORIOS COMBIX, Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use S.L.U. (ARGININA) COMBIX solution Badajoz, 2, Edificio 2 600 mg GRANULADO 28223 Pozuelo de Alarcón PARA SOLUCION ORAL (Madrid) EFG Spain Spain Farmalider S.A. Ibuprofen arginine IBUPROFENO 200 mg Granules for oral Oral use C/ Aragoneses, 15 (ARGININA) solution Alcobendas (Madrid), 28108 FARMALIDER 200 MG Spain GRANULADO PARA SOLUCION ORAL Spain KERN PHARMA, S.L. Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use Venus, 72. Poligono (ARGININA) KERN solution Industrial Colon II. Tarrasa PHARMA 600 mg (Barcelona) 08228 GRANULADO PARA Spain SOLUCION ORAL EFG

288

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain MYLAN PHARMACEUTICALS, Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use S.L. (ARGININA) MYLAN 600 solution Plom 2-4, mg GRANULADO PARA 5º planta SOLUCION ORAL EFG 08038 Barcelona Spain Spain LABORATORIOS NORMON, Ibuprofen arginine IBUPROFENO 400 mg Granules for oral Oral use S.A. (ARGININA) NORMON solution Ronda de Valdecarrizo, 6 400 mg GRANULADO Tres Cantos (Madrid), 28670 PARA SOLUCION ORAL Spain EFG Spain LABORATORIOS NORMON, Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use S.A. (ARGININA) NORMON solution Ronda de Valdecarrizo, 6 600 mg GRANULADO Tres Cantos (Madrid), 28670 PARA SOLUCION ORAL Spain EFG Spain PENSA PHARMA, S.A.U. Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use Jorge Comín (médico (ARGININA) PENSA 600 solution pediatra), 3 mg GRANULADO PARA 46015 Valencia SOLUCION ORAL EFG Spain Spain RATIOPHARM ESPAÑA, S.A. Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use Avda. de Burgos, 16 D-5ª (ARGININA) solution planta RATIOPHARM 600 mg 28036 Madrid GRANULADO PARA Spain SOLUCION ORAL EFG

289

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain SANDOZ FARMACÉUTICA, Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use S.A. (ARGININA) SANDOZ solution Avda. Osa Mayor 600 mg GRANULADO 28023 Aravaca (Madrid) PARA SOLUCION ORAL Spain EFG Spain LABORATORIO STADA, S.A. Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use Frederic Mompou, 5 (ARGININA) STADA 600 solution 08960 Sant Just Desvern mg GRANULADO PARA (Barcelona) SOLUCION ORAL EFG Spain Spain TARBIS FARMA, S.L. Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use Gran Via Carlos III, 94 (ARGININA) TARBIS solution Barcelona, 08028 600 mg GRANULADO Spain PARA SOLUCION ORAL EFG Spain TECNIMEDE ESPAÑA Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use INDUSTRIA FARMACEUTICA, (ARGININA) TECNIGEN solution S.A. 600 mg GRANULADO Avda. de Bruselas, 13 PARA SOLUCION ORAL 3º D.Edificio América EFG Polígono Arroyo de la Vega Alcobendas (Madrid), 28108 Spain Spain TEVA PHARMA, S.L.U. Ibuprofen IBUPROFENO 600 mg Granules for oral Oral use Anabel Segura, 11 (ARGININA) TEVA 600 solution Edificio Albatros B, 1ª planta mg GRANULADO PARA 28108 Alcobendas (Madrid) SOLUCIÓN ORAL EFG Spain

290

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain Zentiva, k.s. Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use U kabelovny 130 (ARGININA) ZENTIVA solution 102 37 Praha 10 600 mg GRANULADO Dolní Měcholupy PARA SOLUCION ORAL Czech Republic EFG Spain LABORATORIOS NORMON, Ibuprofen arginine NORMODOL 400 mg 400 mg Granules for oral Oral use S.A. GRANULADO PARA solution Ronda de Valdecarrizo, 6 SOLUCION ORAL EFG Tres Cantos (Madrid), 28670 Spain Spain Farmalider S.A. Ibuprofen arginine POINDOL 200 MG 200 mg Granules for oral Oral use C/ Aragoneses, 15 GRANULADO PARA solution Alcobendas (Madrid), 28108 SOLUCION ORAL Spain Spain Boehringer Ingelheim Ibuprofen BUSCAFEM 400 MG 400 mg Capsule, soft Oral use International GmbH CAPSULAS BLANDAS Binger Straße 173 EFG 55216 Ingelheim am Rhein Germany Spain Ceninter, S.A. Ibuprofen DOLENCAR 200 mg 200 mg Capsule, soft Oral use Avda. San Pablo, 27 CAPSULAS BLANDAS Coslada (Madrid), 28823 Spain Spain Ceninter, S.A. Ibuprofen DOLENCAR 400 mg 400 mg Capsule, soft Oral use Avda. San Pablo, 27 CAPSULAS BLANDAS Coslada (Madrid), 28823 Spain

291

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain Juste, S.A.Q.F. Ibuprofen DOLTRA 200 mg 200 mg Capsule, soft Oral use Avda. San Pablo, 27 CAPSULAS BLANDAS Coslada (Madrid) 28823 Spain Spain Juste, S.A.Q.F. Ibuprofen DOLTRA 400 mg 400 mg Capsule, soft Oral use Avda. San Pablo, 27 CAPSULAS BLANDAS Coslada (Madrid) 28823 Spain Spain Reckitt Benckiser Healthcare Ibuprofen NUROFEN 400 mg 400 mg Capsule, soft Oral use S.A. CAPSULAS BLANDAS Mataró, 28. Granollers (Barcelona), 08403 Spain Spain LABORATORIOS GEBRO Dexibuprofen ATRISCAL 300 mg 300 mg Film-coated tablet Oral use PHARMA, S.A. comprimidos Avenida Tibidabo, 29 recubiertos con película 08022 Barcelona Spain Spain LABORATORIOS GEBRO Dexibuprofen ATRISCAL 400 mg 400 mg Film-coated tablet Oral use PHARMA, S.A. comprimidos Avenida Tibidabo, 29 recubiertos con película 08022 Barcelona Spain

292

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain LABORATORIOS GEBRO Dexibuprofen SERACTIL 400 mg 400 mg Film-coated tablet Oral use PHARMA, S.A. comprimidos Avenida Tibidabo, 29 recubiertos con película 08022 Barcelona Spain Spain FARMASIERRA Ibuprofen ASTEFOR 400 mg/30 400 mg Film-coated tablet Oral use LABORATORIOS, S.L. Ctra. codeine phosphate mg comprimidos 30 mg Irún, km.26,200 hemihydrate recubiertos con película San Sebastián de los Reyes (Madrid) 28700 Spain Spain Abbott Laboratories, S.A. Ibuprofen NEOBRUFEN CON 400 mg Film-coated tablet Oral use Avda. de Burgos, 91 codeine phosphate CODEÍNA 400 mg/30 30 mg 28050 Madrid hemihydrate mg comprimidos Spain recubiertos con película Spain Cantabria Pharma, S.L. Ibuprofen NIDOL 400 mg/30 mg 400 mg Film-coated tablet Oral use Ribera del Loira, 46 edificio codeine phosphate comprimidos 30 mg 2 hemihydrate recubiertos con película 28042 Madrid Spain Spain Boehringer Ingelheim Ibuprofen BISOLFREN 200 mg/30 200 mg Film-coated tablet Oral use International GmbH pseudoephedrine mg comprimidos 30 mg Binger Straße 173 hydrochloride recubiertos con película 55216 Ingelheim am Rhein Germany

293

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain FARMASIERRA Ibuprofen ASTEFOR 400 mg/30 400 mg Granules for oral Oral use LABORATORIOS, S.L. Ctra. codeine phosphate mg GRANULADO PARA 30 mg suspension Irún, km.26,200 hemihydrate SUSPENSION ORAL San Sebastián de los Reyes (Madrid) 28700 Spain Spain KERN PHARMA, S.L. Ibuprofen arginine IBUKERN (ARGININA) 200 mg/ml Oral solution Oral use Venus, 72. Poligono codeine phosphate CODEINA 200 MG/ML + 10 mg/ml Industrial Colon II. Tarrasa hemihydrate 10 MG/ML SOLUCION (Barcelona) 08228 ORAL Spain Spain Farmalider S.A. Ibuprofen arginine IBUCOD 200 MG/ML + 200 mg/ml Oral solution Oral use C/ Aragoneses, 15 codeine phosphate 10 MG/ML SOLUCION 10 mg/ml Alcobendas (Madrid), 28108 hemihydrate ORAL Spain Spain LABORATORIOS SALVAT, Ibuprofen SALVARINA CAPSULAS 200 mg Capsule, hard Oral use S.A. caffeine 50 mg Gall, 30-36 dimenhydrinate 15 mg Esplugues de Llobregat (Barcelona) 08950 Spain

294

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Spain LABORATORIOS PEREZ Ibuprofen IBUPROFENO CUVE 600 600 mg Film-coated tablet Oral use GIMENEZ, S.A. mg comprimidos EFG Polígono Industrial Los Mochos Polígono 8-parcela 20. Crta. A-431, Km. 19 14720 Almodovar del Río (Córdoba) Spain Spain LABORATORIOS PEREZ Ibuprofen arginine IBUPROFENO 600 mg Granules for oral Oral use GIMENEZ, S.A. (ARGININA) CUVE 600 solution Pol. Ind. Los Mochos. mg GRANULADO PARA Polígono 8 - Parcela 20. SOLUCION ORAL EFG Crta. A-431, Km 19, Almodovar del Río (Córdoba), 14720, Spain. Spain LABORATORIOS Ibuprofen IBUPROFENO NUPEL 600 mg Film-coated tablet Oral use ASOCIADOS NUPEL, S.L. 600 mg comprimidos Rua Carpinteiros, 25 Polígono Industrial Ceao 27003 Lugo Spain Sweden Recip AB Ibuprofen Alindrin 600 mg Film-coated tablet Oral use P.O Box 906 SE-170 09 Solna Sweden

295

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Sweden Recip AB Ibuprofen Alindrin 200 mg Film-coated tablet Oral use P.O Box 906 SE-170 09 Solna Sweden Sweden Recip AB Ibuprofen Alindrin 400 mg Film-coated tablet Oral use P.O Box 906 SE-170 09 Solna Sweden Sweden Mundipharma AB, Ibuprofen Ardinex 200 mg Tablet Oral use Mölndalsvägen 30 B SE-412 codeine phosphate 30 mg 63 Göteborg, Sweden hemihydrate Sweden Abbott Scandinavia AB Ibuprofen Brufen 400 mg Effervescent granules Oral use P.O Box 1498 SE-171 29 Solna Sweden Sweden Abbott Scandinavia AB Ibuprofen Brufen 200 mg Film-coated tablet Oral use P.O Box 1498 SE-171 29 Solna Sweden Sweden Abbott Scandinavia AB Ibuprofen Brufen 400 mg Film-coated tablet Oral use P.O Box 1498 SE-171 29 Solna Sweden Sweden Abbott Scandinavia AB Ibuprofen Brufen 20 mg/ml Oral suspension Oral use P.O Box 1498 SE-171 29 Solna Sweden

296

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Sweden Abbott Scandinavia AB Ibuprofen Brufen 600 mg Film-coated tablet Oral use P.O Box 1498 SE-171 29 Solna Sweden Sweden Abbott Scandinavia AB Ibuprofen Brufen Retard 800 mg Prolonged-release Oral use P.O Box 1498 tablet SE-171 29 Solna Sweden Sweden Orion Corporation Ibuprofen Burana 800 mg Film-coated tablet Oral use Orionintie 1 FIN-02200 Espoo Finland Sweden Orion Corporation Ibuprofen Burana 200 mg Film-coated tablet Oral use Orionintie 1 FIN-02200 Espoo Finland Sweden Orion Corporation Ibuprofen Burana 400 mg Film-coated tablet Oral use Orionintie 1 FIN-02200 Espoo Finland Sweden Orion Corporation Ibuprofen Burana 600 mg Film-coated tablet Oral use Orionintie 1 FIN-02200 Espoo Finland Sweden Orion Corporation Ibuprofen Burana Comp 200 mg Film-coated tablet Oral use Orionintie 1 codeine phosphate 30 mg FIN-02200 Espoo hemihydrate Finland

297

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Sweden Orion Corporation Ibuprofen Burana Comp 400 mg/60 Film-coated tablet Oral use Orionintie 1 codeine phosphate mg FIN-02200 Espoo hemihydrate Finland Sweden Infirst Healthcare Ltd. Ibuprofen Flarin 200 mg Capsule, soft Oral use Strand 265 London WC2R 1BH United Kingdom Sweden Infirst Healthcare Ltd. Ibuprofen Flarin 400 mg Capsule, soft Oral use Strand 265 London WC2R 1BH United Kingdom Sweden Vitabalans Oy Ibuprofen Ibumax 200 mg Film-coated tablet Oral use Varastokatu 8 FI-13500 Tavastehus Finland Sweden Vitabalans Oy Ibuprofen Ibumax 400 mg Film-coated tablet Oral use Varastokatu 8 FI-13500 Tavastehus Finland Sweden Vitabalans Oy Ibuprofen Ibumax 600 mg Film-coated tablet Oral use Varastokatu 8 FI-13500 Tavastehus Finland Sweden Takeda Pharma AB Ibuprofen Ibumetin 200 mg Tablet Oral use P.O Box 3131 SE-169 03 Solna Sweden

298

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Sweden Takeda Pharma AB Ibuprofen Ibumetin 400 mg Tablet Oral use P.O Box 3131 SE-169 03 Solna Sweden Sweden Takeda Pharma AB Ibuprofen Ibumetin 600 mg Tablet Oral use P.O Box 3131 SE-169 03 Solna Sweden Sweden Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Sweden Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Sweden Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 600 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Sweden Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 800 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

299

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Sweden Apofri AB Ibuprofen Ibuprofen Apofri 200 mg Film-coated tablet Oral use P.O Box 120 SE-182 12 Danderyd Sweden Sweden Apofri AB Ibuprofen Ibuprofen Apofri 400 mg Film-coated tablet Oral use P.O Box 120 SE-182 12 Danderyd Sweden Sweden Banner Pharmacaps Europe Ibuprofen Ibuprofen Banner 400 mg Capsule, soft Oral use B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands Sweden Farmalider S.A. Ibuprofen Ibuprofen Farmalider 20 mg/ml Oral suspension Oral use C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain Sweden Farmalider S.A. Ibuprofen Ibuprofen Farmalider 40 mg/ml Oral suspension Oral use C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain Sweden Orifarm Generics A/S Ibuprofen Ibuprofen Orifarm 200 mg Film-coated tablet Oral use Energivej 15 POB 69 DK-5260 Odense S Denmark

300

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Sweden Orifarm Generics A/S Ibuprofen Ibuprofen Orifarm 400 mg Film-coated tablet Oral use Energivej 15 POB 69 DK-5260 Odense S Denmark Sweden Orifarm Generics A/S Ibuprofen Ibuprofen Orifarm 600 mg Film-coated tablet Oral use Energivej 15 POB 69 DK-5260 Odense S Denmark Sweden ratiopharm GmbH Ibuprofen Ibuprofen ratiopharm 200 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Sweden ratiopharm GmbH Ibuprofen Ibuprofen ratiopharm 400 mg Film-coated tablet Oral use Graf-Arco-Str. 3 89079 Ulm Germany Sweden Apofri AB Ibuprofen lysine Ibuzin 400 mg Film-coated tablet Oral use P.O Box 120 SE-182 12 Danderyd Sweden Sweden Actavis Group PTC ehf Ibuprofen Ifenin 200 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

301

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

Sweden Actavis Group PTC ehf Ibuprofen Ifenin 400 mg Film-coated tablet Oral use Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland Sweden McNeil Sweden AB Ibuprofen Ipren 200 mg Film-coated tablet Oral use SE-169 90 Solna Sweden Sweden McNeil Sweden AB Ibuprofen Ipren 400 mg Film-coated tablet Oral use SE-169 90 Solna Sweden Sweden McNeil Sweden AB Ibuprofen Ipren 400 mg Capsule, soft Oral use SE-169 90 Solna Sweden Sweden Nordic Drugs AB Dexibuprofen Tradil 300 mg Film-coated tablet Oral use Box 30035 200 61 Limhamn Sweden Sweden Nordic Drugs AB Dexibuprofen Tradil 400 mg Film-coated tablet Oral use Box 30035 200 61 Limhamn Sweden The Abbott B.V Ibuprofen Brufen Bruis, 600 mg Effervescent granules Oral use Netherlands Wegalaan 9 bruisgranulaat in 2132 JD HOOFDDORP sachets 600 mg The Netherlands

302

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Abbott B.V Ibuprofen Brufen Retard, 800 mg Prolonged-release Oral use Netherlands Wegalaan 9 tabletten met tablet 2132 JD HOOFDDORP gereguleerde afgifte The Netherlands 800 mg The Abbott B.V Ibuprofen Brufen 400 mg 400 mg Effervescent granules Oral use Netherlands Wegalaan 9 bruisgranulaat 2132 JD HOOFDDORP The Netherlands The Actavis B.V. Ibuprofen Ibuprofen Actavis 400 mg Capsule, soft Oral use Netherlands Baarnsche Dijk 1 Liquid Caps 400 mg, 3741 LN Baarn capsule, zacht The Netherlands The Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 200 200 mg Film-coated tablet Oral use Netherlands Reykjavíkurvegi 76-78 mg, filmomhulde 220 Hafnarfjörður tabletten Iceland The Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 400 400 mg Film-coated tablet Oral use Netherlands Reykjavíkurvegi 76-78 mg, filmomhulde 220 Hafnarfjörður tabletten Iceland The Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 400 400 mg Film-coated tablet Oral use Netherlands Reykjavíkurvegi 76-78 mg, filmomhulde 220 Hafnarfjörður tabletten Iceland The Actavis Group PTC ehf Ibuprofen Ibuprofen Actavis 600 600 mg Film-coated tablet Oral use Netherlands Reykjavíkurvegi 76-78 mg, filmomhulde 220 Hafnarfjörður tabletten Iceland

303

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Apotex Europe BV Ibuprofen Albert Heijn Ibuprofen 200 mg Coated tablet Oral use Netherlands Darwinweg 20 200 mg , omhulde 2333 CR Leiden tabletten The Netherlands The Apotex Europe BV Ibuprofen Albert Heijn Ibuprofen 400 mg Coated tablet Oral use Netherlands Darwinweg 20 400 mg , omhulde 2333 CR Leiden tabletten The Netherlands The Apotex Europe B.V. Ibuprofen Ibuprofen Apotex 200 200 mg Coated tablet Oral use Netherlands Darwinweg 20 mg, omhulde tabletten 2333 CR Leiden The Netherlands The Apotex Europe B.V. Ibuprofen Ibuprofen Apotex 200 200 mg Film-coated tablet Oral use Netherlands Darwinweg 20 mg, tabletten 2333 CR Leiden The Netherlands The Apotex Europe B.V. Ibuprofen Ibuprofen Apotex 400 400 mg Capsule, soft Oral use Netherlands Darwinweg 20 mg capsules, zacht 2333 CR Leiden The Netherlands The Apotex Europe B.V. Ibuprofen Ibuprofen Apotex 400 400 mg Film-coated tablet Oral use Netherlands Darwinweg 20 mg, omhulde tabletten 2333 CR Leiden The Netherlands The Apotex Europe B.V. Ibuprofen Ibuprofen Apotex 400 400 mg Coated tablet Oral use Netherlands Darwinweg 20 mg, omhulde tabletten 2333 CR Leiden The Netherlands

304

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Apotex Europe B.V. Ibuprofen Ibuprofen Apotex 400 400 mg Film-coated tablet Oral use Netherlands Darwinweg 20 mg, tabletten 2333 CR Leiden The Netherlands The Apotex Europe B.V. Ibuprofen Ibuprofen Apotex 500 500 mg Suppository Rectal use Netherlands Darwinweg 20 mg, zetpillen 2333 CR Leiden The Netherlands The Apotex Europe B.V. Ibuprofen Ibuprofen Apotex 600 600 mg Film-coated tablet Oral use Netherlands Darwinweg 20 mg, omhulde tabletten 2333 CR Leiden The Netherlands The Apotex Europe B.V. Ibuprofen Ibuprofen Apotex 600 600 mg Film-coated tablet Oral use Netherlands Darwinweg 20 mg, tabletten 2333 CR Leiden The Netherlands The Apotex Europe B.V. Ibuprofen Ibuprofen liquid caps 400 mg Capsule, soft Oral use Netherlands Darwinweg 20 Apotex 400 mg, 2333 CR Leiden capsules, zacht The Netherlands The Banner Pharmacaps Europe Ibuprofen Ibuprofen Banner 100 100 mg Chewable capsule, Oral use Netherlands B.V. mg, kauwcapsules, soft De Posthoornstraat 7 zacht 5048 AS Tilburg The Netherlands

305

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Banner Pharmacaps Europe Ibuprofen Ibuprofen Banner 400 400 mg Capsule, soft Oral use Netherlands B.V. mg capsules, zacht De Posthoornstraat 7 5048 AS Tilburg The Netherlands The Bayer B.V. Ibuprofen Saridon ibuprofen 200 200 mg Film-coated tablet Oral use Netherlands Energieweg 1 mg, filmomhulde 3641 RT Mijdrecht tabletten The Netherlands The Bayer B.V. Ibuprofen Sarixell 400 mg, 400 mg Film-coated tablet Oral use Netherlands Energieweg 1 filmomhulde tabletten 3641 RT Mijdrecht The Netherlands The Centrafarm B.V. Ibuprofen Ibuprofen CF 600 mg, 600 mg Film-coated tablet Oral use Netherlands Nieuwe Donk 3 omhulde tabletten 4879 AC Etten Leur The Netherlands The Centrafarm B.V. Ibuprofen Ibuprofen CF 400 mg, 400 mg Film-coated tablet Oral use Netherlands Nieuwe Donk 3 omhulde tabletten 4879 AC Etten Leur The Netherlands The ETOS B.V. Ibuprofen Etos Ibuprofen Liquid 400 mg Capsule, soft Oral use Netherlands Provincialeweg 11 caps 400 mg, capsules, 1506 MA Zaandam zacht The Netherlands

306

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Fair-Med Healthcare GmbH Ibuprofen Ibuprofen FAIR-MED 200 mg Film-coated tablet Oral use Netherlands Planckstr. 13 200 mg filmomhulde 22765 Hamburg tabletten Germany The Fair-Med Healthcare GmbH Ibuprofen Ibuprofen FAIR-MED 400 mg Film-coated tablet Oral use Netherlands Planckstr. 13 400 mg filmomhulde 22765 Hamburg tabletten Germany The Fair-Med Healthcare GmbH Ibuprofen Ibuprofen FAIR-MED 600 mg Film-coated tablet Oral use Netherlands Planckstr. 13 600 mg filmomhulde 22765 Hamburg tabletten Germany The Galpharm Healthcare Ibuprofen Ibuprofen Galpharm 200 mg Film-coated tablet Oral use Netherlands Limited 200 mg, filmomhulde Hugh House tabletten Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom The Galpharm Healthcare Ibuprofen Ibuprofen Galpharm 400 mg Film-coated tablet Oral use Netherlands Limited 400 mg, filmomhulde Hugh House tabletten Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

307

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The GenRx B.V. Ibuprofen Ibuprofen 400 mg, 400 mg Film-coated tablet Oral use Netherlands Dijkgraaf 30 tabletten 6921 RL Duiven The Netherlands The GenRx B.V. Ibuprofen Ibuprofen 600 mg, 600 mg Film-coated tablet Oral use Netherlands Dijkgraaf 30 tabletten 6921 RL Duiven The Netherlands The Healthypharm B.V. Ibuprofen Ibuprofen HTP liquid 400 mg Capsule, soft Oral use Netherlands Nieuwe Donk 3 caps 400 mg, capsules, 4879 AC Etten-Leur zacht The Netherlands The Healthypharm B.V. Ibuprofen Ibuprofen HTP 200 mg, 200 mg Film-coated tablet Oral use Netherlands Nieuwe Donk 3 omhulde tabletten 4879 AC Etten-Leur The Netherlands The Healthypharm B.V. Ibuprofen Ibuprofen HTP 400 mg, 400 mg Film-coated tablet Oral use Netherlands Nieuwe Donk 3 omhulde tabletten 4879 AC Etten-Leur The Netherlands The Healthypharm B.V. Ibuprofen Ibuprofen liquid caps 400 mg Capsule, soft Oral use Netherlands Nieuwe Donk 3 400 mg HTP Huismerk, 4879 AC Etten-Leur capsules, zacht The Netherlands

308

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The HEMA B.V. Ibuprofen HEMA Ibuprofen 200 200 mg Film-coated tablet Oral use Netherlands NDSM-straat 10 mg, omhulde tabletten 1033 SB Amsterdam The Netherlands The HEMA B.V. Ibuprofen Hema Ibuprofen 200 200 mg Coated tablet Oral use Netherlands NDSM-straat 10 mg, omhulde tabletten 1033 SB Amsterdam The Netherlands The HTP Huisapotheek B.V. Ibuprofen Ibuprofen 200 mg HTP 200 mg Coated tablet Oral use Netherlands Nieuwe Donk 3 Huisapotheek, omhulde 4879 AC Etten-Leur tabletten The Netherlands The HTP Huisapotheek B.V. Ibuprofen Ibuprofen 400 mg HTP 400 mg Coated tablet Oral use Netherlands Nieuwe Donk 3 Huisapotheek, omhulde 4879 AC Etten-Leur tabletten The Netherlands The Infirst Healthcare Ltd. Ibuprofen Flarin 200 mg capsules, 200 mg Capsule, soft Oral use Netherlands Strand 265 zacht London WC2R 1BH United Kingdom The Infirst Healthcare Ltd. Ibuprofen Flarin 400 mg capsules, 400 mg Capsule, soft Oral use Netherlands Strand 265 zacht London WC2R 1BH United Kingdom The Jumbo Supermarkten B.V. Ibuprofen JUMBO Ibuprofen 200 200 mg Film-coated tablet Oral use Netherlands Rijksweg 15 mg, omhulde tabletten 5462 CE Veghel The Netherlands

309

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Leidapharm B.V. Ibuprofen Leidapharm Ibuprofen 400 mg Capsule, soft Oral use Netherlands Archimedesweg 2 400mg Liquid Caps, 2333 CN Leiden capsules, zacht The Netherlands The MAE Holding BV Ibuprofen Ibuprofen MAE 200 mg, 200 mg Film-coated tablet Oral use Netherlands Amsterdamsestraatweg 22 filmomhulde tabletten 1391 AB Abcoude The Netherlands The MAE Holding BV Ibuprofen Ibuprofen Triangle 200 mg Coated tablet Oral use Netherlands Amsterdamsestraatweg 22 Pharma 200 mg, 1391 AB Abcoude omhulde tabletten The Netherlands The MAE Holding BV Ibuprofen Kruidvat Ibuprofen 400 mg Capsule, soft Oral use Netherlands Amsterdamsestraatweg 22 Liquid Caps 400 mg, 1391 AB Abcoude capsules, zacht The Netherlands The MAE Holding BV Ibuprofen Trekpleister Ibuprofen 400 mg Capsule, soft Oral use Netherlands Amsterdamsestraatweg 22 Liquid Caps 400 mg, 1391 AB Abcoude capsules, zacht The Netherlands The Focus Farma B.V Ibuprofen Ibuprofen 200 mg 200 mg Film-coated tablet Oral use Netherlands Lagedijk 1-3 Focus Farma, Koog aan de Zaan filmomhulde tabletten 1541 KA Nederland

310

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Focus Farma B.V Ibuprofen Ibuprofen 400 mg 400 mg Film-coated tablet Oral use Netherlands Lagedijk 1-3 Focus Farma, Koog aan de Zaan filmomhulde tabletten 1541 KA Nederland

The Focus Farma B.V Ibuprofen Ibuprofen 600 mg 600 mg Film-coated tablet Oral use Netherlands Lagedijk 1-3 Focus Farma, Koog aan de Zaan filmomhulde tabletten 1541 KA Nederland

The Mediq Farma B.V. Ibuprofen Ibuprofen Mdq 200 mg, 200 mg Coated tablet Oral use Netherlands Hertogswetering 159 omhulde tabletten 3543 AS Utrecht The Netherlands The Mediq Farma B.V. Ibuprofen Ibuprofen Mdq 400 mg, 400 mg Coated tablet Oral use Netherlands Hertogswetering 159 omhulde tabletten 3543 AS Utrecht The Netherlands The Mylan B.V. Ibuprofen lysine Ibuprofen (als lysine) 342 mg Film-coated tablet Oral use Netherlands Dieselweg 25 Mylan OTC 200 mg, 3752 LB Bunschoten filmomhulde tabletten The Netherlands The Mylan B.V. Ibuprofen lysine Ibuprofen (als lysine) 684 mg Film-coated tablet Oral use Netherlands Dieselweg 25 Mylan OTC 400 mg, 3752 LB Bunschoten filmomhulde tabletten The Netherlands

311

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Mylan B.V. Ibuprofen lysine Ibuprofen (als lysine) 342 mg Film-coated tablet Oral use Netherlands Dieselweg 25 Mylan 200 mg, 3752 LB Bunschoten filmomhulde tabletten The Netherlands The Mylan B.V. Ibuprofen lysine Ibuprofen (als lysine) 684 mg Film-coated tablet Oral use Netherlands Dieselweg 25 Mylan 400 mg, 3752 LB Bunschoten filmomhulde tabletten The Netherlands The Mylan B.V. Ibuprofen Ibuprofen Mylan 200 200 mg Film-coated tablet Oral use Netherlands Dieselweg 25 mg, omhulde tabletten 3752 LB Bunschoten The Netherlands The Mylan B.V. Ibuprofen Ibuprofen Mylan 400 400 mg Film-coated tablet Oral use Netherlands Dieselweg 25 mg, omhulde tabletten 3752 LB Bunschoten The Netherlands The Mylan B.V. Ibuprofen Ibuprofen Mylan 600 600 mg Film-coated tablet Oral use Netherlands Dieselweg 25 mg, omhulde tabletten 3752 LB Bunschoten The Netherlands The Nedac Sorbo B.V. Ibuprofen NEDAC SORBO 200 mg Coated tablet Oral use Netherlands Innovatie 1 Ibuprofen 200 mg, 6921 RN Duiven omhulde tabletten The Netherlands

312

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Nedac Sorbo B.V. Ibuprofen NEDAC SORBO 400 mg Coated tablet Oral use Netherlands Innovatie 1 Ibuprofen 400 mg, 6921 RN Duiven omhulde tabletten The Netherlands The Nederlandse Service Ibuprofen Ibuprofen SAM 200 mg, 200 mg Coated tablet Oral use Netherlands Apotheek Beheer B.V. omhulde tabletten Vonderweg 39a 7468 DC Enter The Netherlands The Nederlandse Service Ibuprofen Ibuprofen SAM 400 mg, 400 mg Coated tablet Oral use Netherlands Apotheek Beheer B.V. omhulde tabletten Vonderweg 39a 7468 DC Enter The Netherlands The Pfizer bv Ibuprofen Advil, dragees 200 mg 200 mg Coated tablet Oral use Netherlands Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands The Pfizer bv Ibuprofen Advil Liquid Caps 400, 400 mg Capsule, soft Oral use Netherlands Rivium Westlaan 142 zachte capsules, 400 2909 LD, Capelle a/d Ijssel mg The Netherlands The Pfizer bv Ibuprofen Advil Liquid-Caps 200, 200 mg Capsule, soft Oral use Netherlands Rivium Westlaan 142 zachte capsules 200 mg 2909 LD, Capelle a/d Ijssel The Netherlands

313

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Pfizer bv Ibuprofen Advil Ovaal 400, 400 mg Film-coated tablet Oral use Netherlands Rivium Westlaan 142 filmomhulde tabletten 2909 LD, Capelle a/d Ijssel 400 mg The Netherlands The Pharmachemie B.V. Ibuprofen Ibuprofen bruis 600 mg 600 mg Effervescent granules Oral use Netherlands Swensweg 5 PCH, bruisgranulaat 2031 GA Haarlem The Netherlands The Pharmachemie B.V. Ibuprofen Ibuprofen caps 200 mg 200 mg Capsule, soft Oral use Netherlands Swensweg 5 PCH, capsule zacht 2031 GA Haarlem The Netherlands The Pharmachemie B.V. Ibuprofen Ibuprofen liquid caps 200 mg Capsule, soft Oral use Netherlands Swensweg 5 200 mg PCH, capsules, 2031 GA Haarlem zacht The Netherlands The Pharmachemie B.V. Ibuprofen Ibuprofen 200 PCH, 200 mg Coated tablet Oral use Netherlands Swensweg 5 omhulde tabletten 200 2031 GA Haarlem mg The Netherlands The Pharmachemie B.V. Ibuprofen Ibuprofen 400 PCH, 400 mg Coated tablet Oral use Netherlands Swensweg 5 omhulde tabletten 400 2031 GA Haarlem mg The Netherlands The Pharmachemie B.V. Ibuprofen Ibuprofen 500 PCH, 500 mg Suppository Rectal use Netherlands Swensweg 5 zetpillen 500 mg 2031 GA Haarlem The Netherlands

314

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Pharmachemie B.V. Ibuprofen Ibuprofen 600 PCH, 600 mg Film-coated tablet Oral use Netherlands Swensweg 5 omhulde tabletten 600 2031 GA Haarlem mg The Netherlands The ratiopharm Nederland B.V. Ibuprofen Ibuprofen ratiopharm 400 mg Film-coated tablet Oral use Netherlands Florapark 4 400 mg, filmomhulde 2012 HK Haarlem tabletten The Netherlands The Reckitt Benckiser Healthcare Ibuprofen Nurofen Fastine Liquid 400 mg Capsule, soft Oral use Netherlands B.V. Caps 400 mg, capsule, Siriusdreef 14 zacht 2132 WT Hoofddorp The Netherlands The Reckitt Benckiser Healthcare Ibuprofen lysine Nurofen Omhulde 342 mg Film-coated tablet Oral use Netherlands B.V. Tabletten 200, omhulde Siriusdreef 14 tabletten 200 mg 2132 WT Hoofddorp The Netherlands The Reckitt Benckiser Healthcare Ibuprofen Nurofen Zavance Lea 200 mg Capsule, soft Oral use Netherlands B.V. 200 mg liquid capsules, Siriusdreef 14 capsules, zacht 2132 WT Hoofddorp The Netherlands The Reckitt Benckiser Healthcare Ibuprofen lysine Nurofen Zavance Oni 683,34 mg Oral powder Oral use Netherlands B.V. 400 mg, poeder voor Siriusdreef 14 oraal gebruik 2132 WT Hoofddorp The Netherlands

315

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Reckitt Benckiser Healthcare Ibuprofen sodium Nurofen Zavance Tex 256 mg Coated tablet Oral use Netherlands B.V. dihydrate 200 mg tablet, omhulde Siriusdreef 14 tabletten 2132 WT Hoofddorp The Netherlands The Reckitt Benckiser Healthcare Ibuprofen sodium Nurofen Zavance Tex 256 mg Coated tablet Oral use Netherlands B.V. dihydrate 200 mg tablet ovaal, Siriusdreef 14 omhulde tabletten 2132 WT Hoofddorp The Netherlands The Reckitt Benckiser Healthcare Ibuprofen sodium Nurofen Zavance Tex 512 mg Coated tablet Oral use Netherlands B.V. dihydrate 400 mg tablet, omhulde Siriusdreef 14 tabletten 2132 WT Hoofddorp The Netherlands The Reckitt Benckiser Healthcare Ibuprofen Nurofen 200 lemon 200 mg Orodispersible tablet Oral use Netherlands B.V. smelttablet, Siriusdreef 14 smelttabletten 200 mg 2132 WT Hoofddorp The Netherlands The Reckitt Benckiser Healthcare Ibuprofen Nurofen 200 tablet, 200 mg Coated tablet Oral use Netherlands B.V. omhulde tabletten 200 Siriusdreef 14 mg 2132 WT Hoofddorp The Netherlands

316

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Reckitt Benckiser Healthcare Ibuprofen Nurofen 200 tablet 200 mg Coated tablet Oral use Netherlands B.V. ovaal, omhulde Siriusdreef 14 tabletten 200 mg 2132 WT Hoofddorp The Netherlands The Reckitt Benckiser Healthcare Ibuprofen Nurofen 400 orange 400 mg Effervescent granules Oral use Netherlands B.V. bruisgranulaat, Siriusdreef 14 bruisgranulaat 400 mg 2132 WT Hoofddorp per sachet The Netherlands The Reckitt Benckiser Healthcare Ibuprofen lysine Nurofen 400 tablet 684 mg Film-coated tablet Oral use Netherlands B.V. Female, filmomhulde Siriusdreef 14 tabletten 400mg 2132 WT Hoofddorp The Netherlands The Reckitt Benckiser Healthcare Ibuprofen lysine Nurofen 400 tablet 684 mg Film-coated tablet Oral use Netherlands B.V. Migraine, filmomhulde Siriusdreef 14 tabletten 400 mg 2132 WT Hoofddorp The Netherlands The Reckitt Benckiser Healthcare Ibuprofen Nurofen 400 tablet, 400 mg Film-coated tablet Oral use Netherlands B.V. omhulde tabletten 400 Siriusdreef 14 mg 2132 WT Hoofddorp The Netherlands

317

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The RXT Ibuprofen Ibuprofen RXT 200 mg, 200 mg Coated tablet Oral use Netherlands Amsterdamsestraatweg 22 omhulde tabletten 1391 AB Abcoude The Netherlands The Sameko Farma B.V. Ibuprofen C1000 Ibuprofen 200 200 mg Coated tablet Oral use Netherlands Archimedesweg 2 mg, omhulde tabletten 2333 CN Leiden The Netherlands The Sameko Farma B.V. Ibuprofen Ibuprofen 200 mg 200 mg Coated tablet Oral use Netherlands Archimedesweg 2 Sameko, omhulde 2333 CN Leiden tabletten The Netherlands The Sameko Farma B.V. Ibuprofen Ibuprofen 400 mg 400 mg Coated tablet Oral use Netherlands Archimedesweg 2 Sameko, omhulde 2333 CN Leiden tabletten The Netherlands The Sameko Farma B.V. Ibuprofen Ibuprofen 400 mg 400 mg Coated tablet Oral use Netherlands Archimedesweg 2 Sameko, omhulde 2333 CN Leiden tabletten The Netherlands The Sameko Farma B.V. Ibuprofen Ibuprofen 400 mg 400 mg Coated tablet Oral use Netherlands Archimedesweg 2 Sameko, omhulde 2333 CN Leiden tabletten The Netherlands

318

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Samenwerkende Apothekers Ibuprofen Ibuprofen 200 mg 200 mg Coated tablet Oral use Netherlands Nederland B.V. omhulde tabletten Kralingseweg 201 Samenwerkende 3062 CE Rotterdam Apothekers, omhulde The Netherlands tabletten The Samenwerkende Apothekers Ibuprofen Ibuprofen 400 mg 400 mg Coated tablet Oral use Netherlands Nederland B.V. omhulde tabletten Kralingseweg 201 Samenwerkende 3062 CE Rotterdam Apothekers, omhulde The Netherlands tabletten The Sandoz B.V. Ibuprofen Ibuprofen Sandoz 200 200 mg Capsule, soft Oral use Netherlands Veluwezoom 22 mg, capsules, zacht 1327 AH Almere The Netherlands The Sandoz B.V. Ibuprofen Ibuprofen Sandoz 400 400 mg Capsule, soft Oral use Netherlands Veluwezoom 22 mg, capsules, zacht 1327 AH Almere The Netherlands The SDG Farma B.V. Ibuprofen Idyl Ibuprofen Liquid 400 mg Capsule, soft Oral use Netherlands Treubweg 11 Caps 400 mg, capsules, 1112 BA Diemen zacht The Netherlands The Teva Nederland B.V. Ibuprofen Ibuprofen Liquid caps 400 mg Capsule, soft Oral use Netherlands Swensweg 5 400 mg Teva, capsule, 2031 GA Haarlem zacht The Netherlands

319

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Wrafton Laboratories Ibuprofen lysine Ibuprofen Wrafton 200 342 mg Film-coated tablet Oral use Netherlands Limited mg, filmomhulde Exeter Road tabletten Wrafton Braunton Devon EX33 2DL United Kingdom The Wrafton Laboratories Ibuprofen lysine Ibuprofen Wrafton 400 684 mg Film-coated tablet Oral use Netherlands Limited mg, filmomhulde Exeter Road tabletten Wrafton Braunton Devon EX33 2DL United Kingdom The Zambon Nederland B.V. IBUPROFEN Zafen 200 bruistablet, 200 mg Effervescent tablet Oral use Netherlands Basicweg 14B ARGININE bruistabletten 200 mg 3821 BR Amersfoort The Netherlands The Zambon Nederland B.V. IBUPROFEN Zafen 400 granulaat, 400 mg Granules for oral Oral use Netherlands Basicweg 14B ARGININE granulaat voor drank solution 3821 BR Amersfoort 400 mg The Netherlands The Zambon Nederland B.V. IBUPROFEN Zafen 400 Tablet, 400 mg Film-coated tablet Oral use Netherlands Basicweg 14B ARGININE filmomhulde tabletten 3821 BR Amersfoort 400 mg The Netherlands

320

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

The Zambon S.p.A. IBUPROFEN Spidifen 400 tablet, 400 mg Film-coated tablet Oral use Netherlands Via Lillo del Duca 10 ARGININE filmomhulde tabletten 20091, Bresso (Mi) 400 mg Italy United Abbott Laboratories Limited Ibuprofen BRUFEN TABLETS 200 mg Coated tablet Oral use Kingdom Abbott House 200MG Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom United Abbott Laboratories Limited Ibuprofen BRUFEN TABLETS 400 mg Coated tablet Oral use Kingdom Abbott House 400MG Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom United Abbott Laboratories Limited Ibuprofen BRUFEN TABLETS 600 mg Coated tablet Oral use Kingdom Abbott House 600MG Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom United Abbott Laboratories Limited Ibuprofen BRUFEN ORAL 600 mg Granules Oral use Kingdom Abbott House GRANULES 600MG Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

321

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Abbott Laboratories Limited Ibuprofen BRUFEN RETARD 800 mg Modified-release Oral use Kingdom Abbott House TABLETS 800MG tablet Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom United Abbott Laboratories Limited Ibuprofen BRUFEN SYRUP 20 mg/ml Syrup Oral use Kingdom Abbott House 100MG/5ML Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom United Abbott Laboratories Limited Ibuprofen BRUFEN 400 mg Effervescent granules Oral use Kingdom Abbott House EFFERVESCENT Vanwall Buisness Park GRANULES 400 MG Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom United Abbott Laboratories Limited Ibuprofen ABBOTT LABS 200 mg Effervescent granules Oral use Kingdom Abbott House IBUPROFEN GRANULES Vanwall Buisness Park 200 MG Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

322

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Abbott Laboratories Limited Ibuprofen ABBOTT LABS 600 mg Effervescent granules Oral use Kingdom Abbott House IBUPROFEN GRANULES Vanwall Buisness Park 600 MG Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom United Accord Healthcare Limited Ibuprofen ACCORD HEALTHCARE 200 mg Coated tablet Oral use Kingdom 5th Floor Charles House IBUPROFEN TABLETS Finchley Road 108-110 BP 200MG London NW3 5JJ United Kingdom United Accord Healthcare Limited Ibuprofen ACCORD HEALTHCARE 400 mg Coated tablet Oral use Kingdom 5th Floor Charles House IBUPROFEN TABLETS Finchley Road 108-110 BP 400 MG London NW3 5JJ United Kingdom United Accord Healthcare Limited Ibuprofen ACCORD HEALTHCARE 600 mg Coated tablet Oral use Kingdom 5th Floor Charles House IBUPROFEN TABLETS Finchley Road 108-110 BP 600 MG London NW3 5JJ United Kingdom United Actavis UK Limited Ibuprofen ACTAVIS IBUPROFEN 200 mg Coated tablet Oral use Kingdom Whiddon Valley TABLETS 200 MG Barnstaple Devon EX32 8NS United Kingdom

323

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Actavis UK Limited Ibuprofen ACTAVIS IBUPROFEN 400 mg Coated tablet Oral use Kingdom Whiddon Valley TABLETS 400MG Barnstaple Devon EX32 8NS United Kingdom United Actavis UK Limited Ibuprofen ACTAVIS IBUPROFEN 600 mg Coated tablet Oral use Kingdom Whiddon Valley TABLETS 600MG Barnstaple Devon EX32 8NS United Kingdom United Activase Pharmaceuticals Ibuprofen ACTIVASE 200 mg Film-coated tablet Oral use Kingdom Limited PHARMACEUTICALS Boumpoulinas Street 11 IBUPROFEN TABLETS PO Box 27783 Nicosia 200MG CY-2433 Cyprus United Activase Pharmaceuticals Ibuprofen LIBROFEM TABLETS 200 mg Film-coated tablet Oral use Kingdom Limited 200MG Boumpoulinas Street 11 PO Box 27783 Nicosia CY-2433 Cyprus

324

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Aspar Pharmaceutcals Ibuprofen ASPAR IBUPROFEN 200 mg Coated tablet Oral use Kingdom Limited TABLETS BP 200MG 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom United Aspar Pharmaceutcals Ibuprofen ASPAR IBUPROFEN 400 mg Coated tablet Oral use Kingdom Limited TABLETS 400MG 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom United Aspar Pharmaceutcals Ibuprofen ASPAR IBUPROFEN 600 mg Coated tablet Oral use Kingdom Limited TABLETS 600MG 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom United Aspar Pharmaceutcals Ibuprofen ASPAR IBUPROFEN 200 mg Coated tablet Oral use Kingdom Limited CAPLETS 200MG 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

325

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Aspar Pharmaceutcals Ibuprofen ASPAR IBUPROFEN 200 mg Coated tablet Oral use Kingdom Limited TABLETS BP 200MG 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom United Aspar Pharmaceutcals Ibuprofen ASPAR PHARMS 400 mg Coated tablet Oral use Kingdom Limited IBUPROFEN TABLETS 29-30 Capitol Way BP 400MG Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom United Athlone Laboratories Ibuprofen ATHLONE LABS 200 mg Coated tablet Oral use Kingdom Limited, IBUPROFEN TABLETS Ballymurray, BP 200MG Roscommon, Ireland United Athlone Laboratories Ibuprofen ATHLONE LABS 400 mg Coated tablet Oral use Kingdom Limited, IBUPROFEN TABLETS Ballymurray, BP 400MG Roscommon, Ireland

326

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Aurobindo Pharma Limited, Ibuprofen AUROBINDO PHARMA 200 mg Coated tablet Oral use Kingdom Ares Block, Odyssey IBUPROFEN TABLETS Business Park, BP 200MG West End Road Ruislip HA4 6QD United Kingdom United Aurobindo Pharma Limited, Ibuprofen AUROBINDO PHARMA 400 mg Coated tablet Oral use Kingdom Ares Block, Odyssey IBUPROFEN TABLETS Business Park, BP 400MG West End Road Ruislip HA4 6QD United Kingdom United Aurobindo Pharma Limited, Ibuprofen AUROBINDO PHARMA 600 mg Film-coated tablet Oral use Kingdom Ares Block, Odyssey IBUPROFEN TABLETS Business Park, BP 600MG West End Road Ruislip HA4 6QD United Kingdom United Ayrton Saunders Limited Ibuprofen SOLUBLE CUPROFEN 200 mg Effervescent tablet Oral use Kingdom North Way IBUPROFEN TABLETS Wealworth Industrial Estate 200MG Andover, Hampshire SP10 5AZ United Kingdom

327

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Ayrton Saunders Limited Ibuprofen DENTOGEN IBUPROFEN 200 mg Film-coated tablet Oral use Kingdom North Way TABLETS BP 200MG Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom United Ayrton Saunders Limited Ibuprofen DENTOGEN SOLUBLE 200 mg Effervescent tablet Oral use Kingdom North Way IBUPROFEN TABLETS Wealworth Industrial Estate 200MG Andover, Hampshire SP10 5AZ United Kingdom United Ayrton Saunders Limited Ibuprofen AYRTON SAUNDERS 200 mg Effervescent tablet Oral use Kingdom North Way IBUPROFEN TABLETS Wealworth Industrial Estate 200MG Andover, Hampshire SP10 5AZ United Kingdom United Ayrton Saunders Limited Ibuprofen AYRTON SAUNDERS 400 mg Effervescent tablet Oral use Kingdom North Way IBUPROFEN TABLETS Wealworth Industrial Estate 400MG Andover, Hampshire SP10 5AZ United Kingdom

328

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Ayrton Saunders Limited Ibuprofen CUFEN-EF IBUPROFEN 200 mg Effervescent tablet Oral use Kingdom North Way TABLETS 200 MG Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom United Banner Pharmacaps Europe Ibuprofen BANNER PHARMACAPS 200 mg Capsule, soft Oral use Kingdom B.V. IBUPROFEN LIQUID De Posthoornstraat 7 CAPSULE 200MG 5048 AS Tilburg The Netherlands United Banner Pharmacaps Europe Ibuprofen BANNER PHARMACAPS 400 mg Capsule, soft Oral use Kingdom B.V. EUROPE BV IBUPROFEN De Posthoornstraat 7 CAPSULES, SOFT 400 5048 AS Tilburg MG The Netherlands United Banner Pharmacaps Europe Ibuprofen BANNER PHARMACAPS 100 mg Capsule, soft Oral use Kingdom B.V. IBUPROFEN CHEWABLE De Posthoornstraat 7 CAPSULES 100MG 5048 AS Tilburg The Netherlands United Bell Sons & Company Ibuprofen BELL SONS IBUPROFEN 200 mg Coated tablet Oral use Kingdom (Druggists) Limited TABLETS 200MG Gifford House Slaidburn Crescent Southport, Merseyside PR9 9AL United Kingdom

329

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Bell Sons & Company Ibuprofen BELL SONS IBUPROFEN 200 mg Capsule, soft Oral use Kingdom (Druggists) Limited CAPSULES 200MG Gifford House Slaidburn Crescent Southport, Merseyside PR9 9AL United Kingdom United Boehringer Ingelheim Ibuprofen LASYNAC TABLETS 200 mg Film-coated tablet Oral use Kingdom International GmbH pseudoephedrine 200MG/30MG 30 mg Binger Straße 173 hydrochloride 55216 Ingelheim am Rhein Germany United Bristol Laboratories Limited, Ibuprofen BRISTOL LABS 200 mg Coated tablet Oral use Kingdom Unit 3, Canalside IBUPROFEN TABLETS Northbridge Road, 200MG Berkhamstead, Hertfordshire HP4 1EG United Kingdom United Bristol Laboratories Limited, Ibuprofen BRISTOL LABS 400 mg Coated tablet Oral use Kingdom Unit 3, Canalside IBUPROFEN TABLETS Northbridge Road, 400MG Berkhamstead, Hertfordshire HP4 1EG United Kingdom

330

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Bristol Laboratories Limited, Ibuprofen BRISTOL LABS 600 mg Film-coated tablet Oral use Kingdom Unit 3, Canalside IBUPROFEN TABLETS Northbridge Road, 600MG Berkhamstead, Hertfordshire HP4 1EG United Kingdom United Bristol Laboratories Limited, Ibuprofen EXTRA STRENGTH 400 mg Coated tablet Oral use Kingdom Unit 3, Canalside IBUPROFEN TABLETS Northbridge Road, 400MG Berkhamstead, Hertfordshire HP4 1EG United Kingdom United Bristol Laboratories Limited, Ibuprofen FENBID BIPHASIC 400 mg Modified-release Oral use Kingdom Unit 3, Canalside CAPSULES 400MG capsule Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom United Chelonia Healthcare Limited Ibuprofen CHELONIA 600 mg Film-coated tablet Oral use Kingdom Boumpoulinas 11 HEALTHCARE 3rd Floor IBUPROFEN TABLETS Nicosia CY-1060 600MG Cyprus United Chelonia Healthcare Limited Ibuprofen EBUFAC TABLETS 400 400 mg Coated tablet Oral use Kingdom Boumpoulinas 11 MG 3rd Floor Nicosia CY-1060 Cyprus

331

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Chelonia Healthcare Limited Ibuprofen MIGRAFEN TABLETS 200 mg Coated tablet Oral use Kingdom Boumpoulinas 11 200MG 3rd Floor Nicosia CY-1060 Cyprus United Chelonia Healthcare Limited Ibuprofen MIGRAFEN TABLETS 200 mg Coated tablet Oral use Kingdom Boumpoulinas 11 200MG 3rd Floor Nicosia CY-1060 Cyprus United Cipla (EU) Limited Ibuprofen STD CHEMICALS 20 mg/ml Oral suspension Oral use Kingdom Hillbrow House IBUPROFEN ORAL Hillbrow Road SUSPENSION 100 MG/ Esher, Surrey 5 ML KT10 9NW United Kingdom United Crescent Pharma Limited Ibuprofen CRESCENT PHARMA 200 mg Coated tablet Oral use Kingdom Units 3 and 4 IBUPROFEN TABLETS Quidhampton Business Units 200MG Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom

332

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Crescent Pharma Limited Ibuprofen CRESCENT PHARMA 400 mg Coated tablet Oral use Kingdom Units 3 and 4 IBUPROFEN TABLETS Quidhampton Business Units 400MG Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom United Crescent Pharma Limited Ibuprofen CRESCENT PHARMA 600 mg Coated tablet Oral use Kingdom Units 3 and 4 IBUPROFEN TABLETS Quidhampton Business Units 600MG Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom United Crescent Pharma Limited Ibuprofen CRESCENT PHARMA 200 mg Coated tablet Oral use Kingdom Units 3 and 4 IBUPROFEN TABLETS Quidhampton Business Units BP 200 MG Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom United Crescent Pharma Limited Ibuprofen CRESCENT PHARMA 400 mg Coated tablet Oral use Kingdom Units 3 and 4 IBUPROFEN TABLETS Quidhampton Business Units BP 400 MG Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom

333

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Crookes Healthcare Limited, Ibuprofen NUROFEN RECOVERY 200 mg Orodispersible tablet Oral use Kingdom Regulatory Department Wellcroft House, Wellcroft Road, Slough, Berkshire SL1 4AQ United Kingdom United Cupal Limited Ibuprofen CUPROFEN TABLETS BP 200 mg Coated tablet Oral use Kingdom Regulatory Department 200MG Wellcroft House Wellcroft Road Slough, Berkshire SL1 4AQ United Kingdom United Cupal Limited Ibuprofen CUPROFEN TABLETS 400 mg Film-coated tablet Oral use Kingdom Regulatory Department 400MG Wellcroft House Wellcroft Road Slough, Berkshire SL1 4AQ United Kingdom United Dalkeith Laboratories Ibuprofen DALKEITH LABS 600 mg Film-coated tablet Oral use Kingdom Limited IBUPROFEN TABLETS 2 Park Street BP 600MG Woburn, Bedfordshire MK17 9PG United Kingdom

334

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Dexcel Pharma Limited, Ibuprofen DEXCEL IBUPROFEN 200 mg Capsule, soft Oral use Kingdom 7 Sopwith Way, LIQUID CAPSULES Drayton Fields Industrial 200MG Estate, Daventry Northamptonshire NN11 8PB United Kingdom United Dexcel Pharma Limited, Ibuprofen DEXCEL IBUPROFEN 400 mg Capsule, soft Oral use Kingdom 7 Sopwith Way, LIQUID CAPSULES Drayton Fields Industrial 400MG Estate, Daventry Northamptonshire NN11 8PB United Kingdom United East Midlands Pharma Ibuprofen EAST MIDLANDS 400 mg Coated tablet Oral use Kingdom Limited PHARMA IBUPROFEN 16 Rancliffe Avenue MAXIMUM STRENGTH Keyworth, Nottinghamshire TABLETS 400MG NG12 5HY United Kingdom United East Midlands Pharma Ibuprofen EAST MIDLANDS 200 mg Coated tablet Oral use Kingdom Limited PHARMA IBUPROFEN 16 Rancliffe Avenue TABLETS 200MG Keyworth, Nottinghamshire NG12 5HY United Kingdom

335

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Ennogen Pharma Limited Ibuprofen ENNOGEN PHARMA 200 mg Coated tablet Oral use Kingdom Unit G4, Riverside Industrial IBUPROFEN TABLETS Estate 200MG Riverside Way Dartford DA1 5BS United Kingdom United Ennogen Pharma Limited Ibuprofen ENNOGEN PHARMA 400 mg Coated tablet Oral use Kingdom Unit G4, Riverside Industrial IBUPROFEN TABLETS Estate 400MG Riverside Way Dartford DA1 5BS United Kingdom United Ennogen Pharma Limited Ibuprofen ENNOGEN PHARMA 600 mg Coated tablet Oral use Kingdom Unit G4, Riverside Industrial IBUPROFEN TABLETS Estate 600MG Riverside Way Dartford DA1 5BS United Kingdom United Ennogen Pharma Limited Ibuprofen IBULAR TABLETS 200 mg Coated tablet Oral use Kingdom Unit G4, Riverside Industrial 200MG Estate Riverside Way Dartford DA1 5BS United Kingdom

336

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Ennogen Pharma Limited Ibuprofen IBULAR TABLETS 400 400 mg Coated tablet Oral use Kingdom Unit G4, Riverside Industrial MG Estate Riverside Way Dartford DA1 5BS United Kingdom United Fannin (UK) Limited Ibuprofen FANNIN (UK) 100 mg Oral suspension Oral use Kingdom 42-46 Booth Drive IBUPROFEN ORAL Park Farm South SUSPENSION Wellingborough NN8 6GT 100MG/5ML United Kingdom United Fourrts (UK) Pharmacare Ibuprofen FOURRTS UK PHARMAC 200 mg Coated tablet Oral use Kingdom Limited IBUPROFEN TABLETS Chaul End Lane 30 200MG Luton, Bedfordshire LU4 8EZ United Kingdom United Fourrts (UK) Pharmacare Ibuprofen FOURRTS UK PHARMAC 200 mg Film-coated tablet Oral use Kingdom Limited IBUPROFEN TABLETS First Floor 200MG 2 Victoria Road Harpenden Hertfordshire AL5 4EA United Kingdom

337

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Fourrts (UK) Pharmacare Ibuprofen FOURRTS UK PHARMAC 200 mg Film-coated tablet Oral use Kingdom Limited IBUPROFEN TABLETS First Floor 200MG 2 Victoria Road Harpenden Hertfordshire AL5 4EA United Kingdom United Fourrts (UK) Pharmacare Ibuprofen FOURRTS UK PHARMAC 400 mg Film-coated tablet Oral use Kingdom Limited IBUPROFEN TABLETS First Floor 400MG 2 Victoria Road Harpenden Hertfordshire AL5 4EA United Kingdom United Fourrts (UK) Pharmacare Ibuprofen FOURRTS UK PHARMAC 600 mg Film-coated tablet Oral use Kingdom Limited IBUPROFEN TABLETS Chaul End Lane 30 600MG Luton, Bedfordshire LU4 8EZ United Kingdom United Galpharm Healthcare Ibuprofen GALPHARM 200 mg Coated tablet Oral use Kingdom Limited HEALTHCARE Hugh House IBUPROFEN TABLETS Upper Cliffe Road 200MG Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

338

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Galpharm Healthcare Ibuprofen GALPHARM 200 mg Coated tablet ORAL USE Kingdom Limited HEALTHCARE Hugh House IBUPROFEN TABLETS Upper Cliffe Road 200MG Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom United Galpharm Healthcare Ibuprofen GALPHARM 20 mg/ml Oral suspension Oral use Kingdom Limited HEALTHCARE Hugh House IBUPROFEN ORAL Upper Cliffe Road SUSPENSION Barnsley, South Yorkshire 100MG/5ML S75 3SP Dodworth Dodworth Bussiness Park United Kingdom United Galpharm Healthcare Ibuprofen GALPHARM IBUPROFEN 400 mg Coated tablet Oral use Kingdom Limited TABLETS 400MG Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

339

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Galpharm Healthcare Ibuprofen JUNIOR IBUPROFEN 20 mg/ml Oral suspension Oral use Kingdom Limited SUSPENSION EX33 2DL Wrafton 100MG/5ML Braunton Devon United Kingdom United Galpharm Healthcare Ibuprofen GALPHARM 20 mg/ml Oral suspension Oral use Kingdom Limited HEALTHCARE EX33 2DL Wrafton IBUPROFEN Braunton SUSPENSION Devon 100MG/5ML United Kingdom United Galpharm Healthcare Ibuprofen GALPHARM 300 mg Modified-release Oral use Kingdom Limited HEALTHCARE capsule Hugh House IBUPROFEN CAPSULES Upper Cliffe Road 300MG Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom United Galpharm Healthcare Ibuprofen GALPHARM 200 mg Capsule Oral use Kingdom Limited HEALTHCARE Hugh House IBUPROFEN CAPSULES Upper Cliffe Road 200MG Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

340

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Galpharm Healthcare Ibuprofen GALPHARM 200 mg Capsule Oral use Kingdom Limited HEALTHCARE Hugh House IBUPROFEN CAPSULES Upper Cliffe Road 200MG Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom United Galpharm Healthcare Ibuprofen GALPHARM 200 mg Modified-release Oral use Kingdom Limited HEALTHCARE capsule, hard Hugh House IBUPROFEN LONG Upper Cliffe Road LASTING CAPSULES Barnsley, South Yorkshire 200MG S75 3SP Dodworth Dodworth Bussiness Park United Kingdom United Galpharm Healthcare Ibuprofen GALPHARM 200 mg Film-coated tablet Oral use Kingdom Limited HEALTHCARE Hugh House IBUPROFEN TABLETS Upper Cliffe Road 200 MG Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

341

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Galpharm Healthcare Ibuprofen GALPHARM IBUPROFEN 400 mg Film-coated tablet Oral use Kingdom Limited TABLETS 400 MG Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom United Generics UK Ibuprofen GENERICS UK 200 mg Tablet Oral use Kingdom Albany Gate IBUPROFEN TABLETS Darkes Lane 200MG Potters Bar Hertfordshire EN6 1AG United Kingdom United Generics UK Ibuprofen GENERICS UK 400 mg Tablet Oral use Kingdom Albany Gate IBUPROFEN TABLETS Darkes Lane 400MG Potters Bar Hertfordshire EN6 1AG United Kingdom United Generics UK Ibuprofen GENERICS UK 600 mg Tablet Oral use Kingdom Albany Gate IBUPROFEN TABLETS Darkes Lane 600MG Potters Bar Hertfordshire EN6 1AG United Kingdom

342

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Generics UK Ibuprofen lysine GENERICS UK 342 mg Film-coated tablet Oral use Kingdom Albany Gate MIGRAINE RELIEF Darkes Lane TABLETS 342 MG Potters Bar Hertfordshire EN6 1AG United Kingdom United Horizon Pharma Gmbh Ibuprofen DUEXIS TABLETS 800 mg Film-coated tablet Oral use Kingdom Joseph Meyer Strasse 13-15 68167 Mannheim Germany United Flamingo Pharma (UK) Ibuprofen FLAMINGO PHARMA 200 mg Coated tablet Oral use Kingdom Limited IBUPROFEN TABLETS 1st Floor, Kirkland House 200MG 11-15 Peterborough Road Harrow Middlesex HA1 2AX United Kingdom United Flamingo Pharma (UK) Ibuprofen FLAMINGO PHARMA 400 mg Coated tablet Oral use Kingdom Limited IBUPROFEN TABLETS 1st Floor, Kirkland House 400 MG 11-15 Peterborough Road Harrow Middlesex HA1 2AX United Kingdom

343

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Flamingo Pharma (UK) Ibuprofen FLAMINGO PHARMA 200 mg Coated tablet Oral use Kingdom Limited IBUPROFEN TABLETS 1st Floor, Kirkland House 200MG 11-15 Peterborough Road Harrow Middlesex HA1 2AX United Kingdom United M & A Pharmachem ltd Ibuprofen M&A PHARMACHEM 600 mg Tablet Oral use Kingdom Allenby Laboratories IBUPROFEN TABLETS Wigan Road BP 600MG Westhoughton Bolton BL5 2AL United Kingdom United M & A Pharmachem ltd Ibuprofen M&A PHARMACHEM 400 mg Tablet Oral use Kingdom Allenby Laboratories IBUPROFEN TABLETS Wigan Road BP 400MG Westhoughton Bolton BL5 2AL United Kingdom United Max Remedies Limited Ibuprofen MAX REMEDIES 200 mg Tablet Oral use Kingdom Stoney Gate House IBUPROFEN TABLETS 2 Greenfield Road 200MG Holmfirth W Yorkshire HD9 2JT United Kingdom

344

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Max Remedies Limited Ibuprofen MAX REMEDIES 400 mg Coated tablet Oral use Kingdom Stoney Gate House IBUPROFEN TABLETS 2 Greenfield Road 400MG Holmfirth W Yorkshire HD9 2JT United Kingdom United MCNeil Products Limited Ibuprofen SUDAFED SINUS 200 mg Tablet Oral use Kingdom Johnson & Johnson Ltd TABLETS PRESSURE & UK Regulatory Department PAIN Foundation Park Roxborough Maidenhead Berkshire SL6 3UG United Kingdom United Mercury Pharma Group Ltd Ibuprofen FENBID 300 mg Modified-release Oral use Kingdom No 1 Croydon capsule 12-16 Addiscombe Road Croydon Surrey CR0 0XT United Kingdom United Mercury Pharmaceuticals Ltd Ibuprofen MERCURY PHARMS 200 mg Coated tablet Oral use Kingdom Capital House IBUPROFEN TABLETS King William Street 85 BP 200MG London EC4N 7BL United Kingdom

345

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Mercury Pharmaceuticals Ltd Ibuprofen MERCURY PHARMS 400 mg Coated tablet Oral use Kingdom Capital House IBUPROFEN TABLETS King William Street 85 BP 400MG London EC4N 7BL United Kingdom United Mercury Pharmaceuticals Ltd Ibuprofen MERCURY PHARMS 600 mg Coated tablet Oral use Kingdom Capital House IBUPROFEN TABLETS King William Street 85 BP 600MG London EC4N 7BL United Kingdom United Mercury Pharmaceuticals Ltd Ibuprofen MERCURY PHARMS 200 mg Coated tablet Oral use Kingdom Capital House IBUPROFEN TABLETS King William Street 85 BP 200MG London EC4N 7BL United Kingdom United Mercury Pharmaceuticals Ltd Ibuprofen MERCURY PHARMS 200 mg Coated tablet Oral use Kingdom Capital House IBUPROFEN TABLETS King William Street 85 BP 200MG London EC4N 7BL United Kingdom United Omega Pharma Ltd Ibuprofen HEDEX IBUPROFEN 200 mg Coated tablet Oral use Kingdom 1st Floor TABLETS 200MG Vauxhall Bridge Road 32 London SW1V 2SA United Kingdom

346

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Omega Pharma Ltd Ibuprofen SOLPADEINE MIGRAINE 200 mg Film-coated tablet Oral use Kingdom 1st Floor IBUPROFEN & CODEINE Vauxhall Bridge Road 32 TABLETS London SW1V 2SA United Kingdom United Orbis Consumer Products Ibuprofen ORBIFEN COLD AND 100 mg Oral suspension Oral use Kingdom Limited FLU ORAL SUSPENSION Cunard Road Park Royal London NW10 6PN United Kingdom United Pfizer Consumer Healthcare Ibuprofen ANADIN JOINT PAIN 200 mg Coated tablet Oral use Kingdom Vanwall Road TABLETS 200MG Maidenhead, Berkshire, SL6 4UB United Kingdom United Pfizer Consumer Healthcare Ibuprofen ANADIN IBUPROFEN 200 mg Coated tablet Oral use Kingdom Vanwall Road TABLETS 200MG Maidenhead, Berkshire, SL6 4UB United Kingdom

347

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Pfizer Consumer Healthcare Ibuprofen ADVIL TABLETS 400MG 400 mg Film-coated tablet Oral use Kingdom Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom United Pfizer Consumer Healthcare Ibuprofen ADVIL LIQUIGEL 200 mg Capsule Oral use Kingdom Vanwall Road CAPSULES 200MG Maidenhead, Berkshire, SL6 4UB United Kingdom United Pfizer Consumer Healthcare Ibuprofen ANADIN ULTRA 200 mg Capsule, soft Oral use Kingdom Vanwall Road CAPSULES 200MG Maidenhead, Berkshire, SL6 4UB United Kingdom United Pfizer Consumer Healthcare Ibuprofen ADVIL LIQUI-GEL 400 mg Capsule, soft Oral use Kingdom Walton Oaks CAPSULES 400MG Dorking Road Tadworth, Surrey KT20 7NS United Kingdom

348

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Pfizer Consumer Healthcare Ibuprofen ANADIN ULTRA 400 mg Capsule, soft Oral use Kingdom Vanwall Road DOUBLE STRENGTH Maidenhead, CAPSULES 400MG Berkshire, SL6 4UB United Kingdom United Pfizer Consumer Healthcare Ibuprofen ADVIL TABLETS 200MG 200 mg Effervescent tablet Oral use Kingdom Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom United Pfizer Consumer Healthcare Ibuprofen ADVIL TABLETS 400MG 400 mg Effervescent tablet Oral use Kingdom Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom United Pfizer Consumer Healthcare Ibuprofen ANADIN LIQUIFAST 200 200 mg Effervescent tablet Oral use Kingdom Vanwall Road MG EFFERVESCENT Maidenhead, TABLETS Berkshire, SL6 4UB United Kingdom

349

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Pfizer Consumer Healthcare Ibuprofen ANADIN LIQUIFAST 400 mg Effervescent tablet Oral use Kingdom Vanwall Road TABLETS 400MG Maidenhead, Berkshire, SL6 4UB United Kingdom United PHARMVIT Limited Ibuprofen PHARMVIT IBUPROFEN 200 mg Coated tablet Oral use Kingdom 177 Bilton Road TABLETS 200MG Perivale Middlesex UB6 7HQ United Kingdom United PHARMVIT Limited Ibuprofen PHARMVIT IBUPROFEN 400 mg Coated tablet Oral use Kingdom 177 Bilton Road TABLETS 400MG Perivale Middlesex UB6 7HQ United Kingdom United PHARMVIT Limited Ibuprofen PHARMAVIT 600 mg Coated tablet Oral use Kingdom 177 Bilton Road IBUPROFEN TABLETS Perivale 600MG Middlesex UB6 7HQ United Kingdom United Pinewood Laboratories Ibuprofen PINEWOOD LABS 100 mg Oral suspension Oral use Kingdom Limited IBUPROFEN ORAL Ballymacarbry, Clonmel SUSPENSION Co Tipperary 100MG/5ML Ireland

350

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Pinewood Laboratories Ibuprofen PINEWOOD LABS 100 mg Oral suspension Oral use Kingdom Limited IBUPROFEN ORAL Ballymacarbry, Clonmel SUSPENSION Co Tipperary 100MG/5ML Ireland United Pinewood Laboratories Ibuprofen PINEWOOD LABS 100 mg Oral suspension Oral use Kingdom Limited IBUPROFEN ORAL Ballymacarbry, Clonmel SUSPENSION Co Tipperary 100MG/5ML Ireland United Pinewood Laboratories Ibuprofen PINEWOOD LABS 200 mg Oral suspension Oral use Kingdom Limited IBUPROFEN ORAL Ballymacarbry, Clonmel SUSPENSION Co Tipperary 200MG/5ML Ireland United Pinewood Laboratories Ibuprofen PINEWOOD LABS 200 mg Oral suspension Oral use Kingdom Limited IBUPROFEN ORAL Ballymacarbry, Clonmel SUSPENSION Co Tipperary 200MG/5ML Ireland United Pinewood Laboratories Ibuprofen PINEWOOD LABS 200 mg Oral suspension Oral use Kingdom Limited IBUPROFEN ORAL Ballymacarbry, Clonmel SUSPENSION Co Tipperary 200MG/5ML Ireland

351

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Procter & Gamble (Health & Ibuprofen PROCTER & GAMBLE 200 mg Film-coated tablet Oral use Kingdom Beauty Care) Limited H&BC IBUPROFEN + The Heights, Brooklands PSEUDOEPHEDRINE Weybridge, Surrey KT13 HYDROCHLORIDE 0XP TABLETS United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN EXPRESS 256 200 mg Tablet Oral use Kingdom (UK) Ltd MG TABLETS Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN TABLETS 200 mg Tablet Oral use Kingdom (UK) Ltd 256MG Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN EXPRESS 200 mg Tablet Oral use Kingdom (UK) Ltd CAPLETS 256 MG Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

352

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Reckitt Benckiser Healthcare Ibuprofen NUROFEN COLD AND 200 mg Coated tablet Oral use Kingdom (UK) Ltd FLU TABLETS Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN PLUS 200 mg Coated tablet Oral use Kingdom (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN BACK PAIN 300 mg Modified-release Oral use Kingdom (UK) Ltd. Dansom Lane SUSTAINED RELEASE capsule Hull HU8 7DS CAPSULES 300MG United Kingdom United Reckitt Benckiser Healthcare Ibuprofen lysine NUROFEN MIGRAINE 342 mg Film-coated tablet Oral use Kingdom (UK) Ltd PAIN Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

353

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Reckitt Benckiser Healthcare Ibuprofen NUROFEN MELTLETS 200 mg Orodispersible tablet Oral use Kingdom (UK) Ltd LEMON 200MG Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen lysine NUROFEN MAXIMUM 684 mg Tablet Oral use Kingdom (UK) Ltd STRENGTH MIGRAINE Regulatory Department PAIN CAPLETS 684MG Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN TABLETS 200 mg Coated tablet Oral use Kingdom (UK) Ltd 200MG Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN CAPLETS 200 200 mg Coated tablet Oral use Kingdom (UK) Ltd MG Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

354

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Reckitt Benckiser Healthcare Ibuprofen NUROFEN CAPLETS 200 mg Coated tablet Oral use Kingdom (UK) Ltd 200MG Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN TABLETS 200 mg Coated tablet Oral use Kingdom (UK) Ltd 200MG Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN EXPRESS 200 mg Tablet Oral use Kingdom (UK) Ltd CAPLETS 256MG Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN EXPRESS 400 mg Tablet Oral use Kingdom (UK) Ltd TABLETS 512MG Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

355

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Reckitt Benckiser Healthcare Ibuprofen LEMSIP MAX ALL DAY 200 mg Tablet Oral use Kingdom (UK) Ltd COLD & FLU TABLETS Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen LEMSIP MAX ALL NIGHT 200 mg Tablet Oral use Kingdom (UK) Ltd COLD & FLU TABLETS Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen IBUPROFEN AND 200 mg Film-coated tablet Oral use Kingdom (UK) Ltd PARACETAMOL Regulatory Department 200MG/500MG Wellcroft House TABLETS Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare IBUPROFEN NUROFEN EXPRESS 683,34 mg Powder for oral Oral use Kingdom (UK) Ltd LYSINATE SOLUBLE ORAL solution Regulatory Department POWDER 400MG Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

356

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Reckitt Benckiser Healthcare Ibuprofen NUROFEN CAPSULE 400 400 mg Capsule, soft Oral use Kingdom (UK) Ltd MG Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare IBUPROFEN NUROFEN EXPRESS 683,34 mg Powder for oral Oral use Kingdom (UK) Ltd LYSINATE ORAL POWDER 400MG solution Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN EXPRESS 200 mg Capsule, soft Oral use Kingdom (UK) Ltd PERIOD PAIN Regulatory Department CAPSULES 200MG Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen RECKITT BENCKISER 200 mg Capsule, soft Oral use Kingdom (UK) Ltd HEALTHCARE UK Regulatory Department IBUPROFEN LIQUICAPS Wellcroft House 200MG Wellcroft Road Slough, SL1 4AQ United Kingdom

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Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Reckitt Benckiser Healthcare Ibuprofen NUROMOL 200 mg Film-coated tablet Oral use Kingdom (UK) Ltd 200MG/500MG Regulatory Department TABLETS Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen RECKITT BENCKISER 200 mg Capsule, soft Oral use Kingdom (UK) Ltd IBUPROFEN CAPSULES Regulatory Department 200MG Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN EXPRESS 400 mg Capsule, soft Oral use Kingdom (UK) Ltd LIQUID CAPSULES Regulatory Department 400MG Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen NUROFEN 200MG 200 mg Capsule, soft Oral use Kingdom (UK) Ltd LIQUICAPS PHARMACY Regulatory Department ONLY Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

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Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Reckitt Benckiser Healthcare Ibuprofen sodium NUROFEN EXPRESS 256 256 mg Tablet Oral use Kingdom (UK) Ltd MG TABLETS Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen sodium NUROFEN EXPRESS 256 mg Tablet Oral use Kingdom (UK) Ltd CAPLETS 256MG Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Reckitt Benckiser Healthcare Ibuprofen sodium NUROFEN EXPRESS 512 mg Tablet Oral use Kingdom (UK) Ltd TABLETS 512MG Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom United Relonchem Limited Ibuprofen RELONCHEM 400 mg Film-coated tablet Oral use Kingdom Cheshire House IBUPROFEN TABLETS Gorsey Lane 400MG Widnes WA8 0RP United Kingdom

359

Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Relonchem Limited Ibuprofen RELONCHEM LIMITED 200 mg Coated tablet Oral use Kingdom Cheshire House IBUPROFEN TABLETS Gorsey Lane 200MG Widnes WA8 0RP United Kingdom United Remedica Ltd. Ibuprofen REMEDICA IBUPROFEN 200 mg Coated tablet Oral use Kingdom P.O. Box 51706 TABLETS 200MG CY-3508 Limassol Cyprus United Remedica Ltd. Ibuprofen REMEDICA IBUPROFEN 400 mg Coated tablet Oral use Kingdom P.O. Box 51706 TABLETS 400MG CY-3508 Limassol Cyprus United Remedica Ltd. Ibuprofen REMEDICA IBUPROFEN 400 mg Coated tablet Oral use Kingdom P.O. Box 51706 TABLETS 400MG CY-3508 Limassol Cyprus United Smithkline Beecham (SWG) Ibuprofen IBUPROFEN 200 MG 200 mg Coated tablet Oral use Kingdom Limited Beecham Group PLC FILM-COATED TABLETS 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom

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Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Special Concept Ibuprofen SPECIAL CONCEPT 400 mg Coated tablet Oral use Kingdom Development (UK) Ltd IBUPROFEN TABLETS Unit 1-7 Colonial Way BP 400MG Watford Hertfordshire WD24 4YR United Kingdom United Special Concept Ibuprofen SPECIAL CONCEPT 200 mg Coated tablet Oral use Kingdom Development (UK) Ltd IBUPROFEN TABLETS Unit 1-7 Colonial Way 200MG Watford Hertfordshire WD24 4YR United Kingdom United Special Concept Ibuprofen SPECIAL CONCEPT 200 mg Coated tablet Oral use Kingdom Development (UK) Ltd IBUPROFEN TABLETS Unit 1-7 Colonial Way 200MG Watford Hertfordshire WD24 4YR United Kingdom United SSL International plc Ibuprofen IBUPROFEN & CODEINE 200 mg Tablet Oral use Kingdom Wellcroft House TABLETS Wellcroft Road 200MG/12.8MG Slough, Berkshire SL1 4AQ United Kingdom

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Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Teva UK Limited Ibuprofen GALPHARM IBUPROFEN 200 mg Coated tablet Oral use Kingdom Field House Station TABLETS BP 200MG Approach Harlow Essex CM20 2FB United Kingdom United Teva UK Limited Ibuprofen IBUPROFEN TABLETS 400 mg Coated tablet Oral use Kingdom Field House Station BP 400MG (APSIFEN-F) Approach Harlow Essex CM20 2FB United Kingdom United Teva UK Limited Ibuprofen TEVA UK IBUPROFEN 400 mg Coated tablet Oral use Kingdom Field House Station TABLETS BP 400MG Approach Harlow Essex CM20 2FB United Kingdom United Teva UK Limited Ibuprofen TEVA UK IBUPROFEN 600 mg Film-coated tablet Oral use Kingdom Field House Station TABLETS 600MG Approach Harlow Essex CM20 2FB United Kingdom United The Boots Company PLC Ibuprofen BOOTS IBUPROFEN 200 mg Tablet Oral use Kingdom Nottingham Support Office CAPLETS 200 MG D90 West First 17 Thane Road Nottingham NG90 5EF United Kingdom

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Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United The Boots Company PLC Ibuprofen BOOTS IBUPROFEN 400 mg Tablet Oral use Kingdom Nottingham Support Office CAPLETS 400MG D90 West First 17 Thane Road Nottingham NG90 5EF United Kingdom United The Boots Company PLC Ibuprofen BOOTS COLD & FLU 200 mg Tablet Oral use Kingdom Nottingham Support Office RELIEF WITH D90 West First 17 IBUPROFEN TABLETS Thane Road Nottingham NG90 5EF United Kingdom United The Boots Company PLC Ibuprofen BOOTS IBUPROFEN 200 mg Film-coated tablet Oral use Kingdom Nottingham Support Office AND CODEINE TABLETS D90 West First 17 Thane Road Nottingham NG90 5EF United Kingdom United Thornton & Ross Ltd Ibuprofen CARE IBUPROFEN ORAL 100 mg Oral suspension Oral use Kingdom Linthwaite SUSPENSION Huddersfield HD7 5QH United Kingdom United Vitabiotics Limited, Ibuprofen VITABIOTICS 400 mg Coated tablet Oral use Kingdom 1 Apsley Way IBUPROFEN TABLETS London NW2 7HF 400MG United Kingdom

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Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Vitabiotics Limited, Ibuprofen VITABIOTICS 400 mg Coated tablet Oral use Kingdom 1 Apsley Way IBUPROFEN TABLETS London NW2 7HF 400MG United Kingdom United Waymade Plc Ibuprofen WAYMADE IBUPROFEN 200 mg Coated tablet Oral use Kingdom Sovereign House TABLETS 200MG Miles Gray Road Basildon, Essex SS14 3FR United Kingdom United Waymade Plc Ibuprofen WAYMADE IBUPROFEN 400 mg Coated tablet Oral use Kingdom Sovereign House TABLETS 400MG Miles Gray Road Basildon, Essex SS14 3FR United Kingdom United Waymade Plc Ibuprofen WAYMADE IBUPROFEN 600 mg Film-coated tablet Oral use Kingdom Sovereign House TABLETS 600MG Miles Gray Road Basildon, Essex SS14 3FR United Kingdom United Waymade Plc Ibuprofen WAYMADE IBUPROFEN 200 mg Coated tablet Oral use Kingdom Sovereign House TABLETS BP 200MG Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

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Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Waymade Plc Ibuprofen WAYMADE IBUPROFEN 400 mg Coated tablet Oral use Kingdom Sovereign House TABLETS BP 400MG Miles Gray Road Basildon, Essex SS14 3FR United Kingdom United Waymade Plc Ibuprofen WAYMADE IBUPROFEN 600 mg Coated tablet Oral use Kingdom Sovereign House TABLETS BP 600MG Miles Gray Road Basildon, Essex SS14 3FR United Kingdom United Winthrop Pharmaceuticals Ibuprofen IBUPROFEN AND 200 mg Film-coated tablet Oral use Kingdom Uk Limited PHENYLEPHRINE One Onslow Street HYDROCHLORIDE Guildford, Surrey TABLETS 200 MG/5 MG GU1 4YS United Kingdom United Wockhardt UK Limited Ibuprofen WOCKHARDT UK 200 mg Coated tablet Oral use Kingdom Ash Road North IBUPROFEN TABLETS Wrexham Industrial Estate 200MG Wrexham, LL13 9UF United Kingdom United Wockhardt UK Limited Ibuprofen WOCKHARDT UK 400 mg Coated tablet Oral use Kingdom Ash Road North MAXIMUM STRENGTH Wrexham Industrial Estate IBUPROFEN TABLETS Wrexham, LL13 9UF 400MG United Kingdom

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Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Wockhardt UK Limited Ibuprofen WOCKHARDT UK 200 mg Coated tablet Oral use Kingdom Ash Road North IBUPROFEN CAPLETS Wrexham Industrial Estate 200MG Wrexham, LL13 9UF United Kingdom United Wockhardt UK Limited Ibuprofen WOCKHARDT UK EXTRA 400 mg Coated tablet Oral use Kingdom Ash Road North STRENGTH IBUPROFEN Wrexham Industrial Estate CAPLETS 400MG Wrexham, LL13 9UF United Kingdom United Wockhardt UK Limited Ibuprofen WOCKHARDT UK 200 mg Coated tablet Oral use Kingdom Ash Road North IBUPROFEN TABLETS Wrexham Industrial Estate 200MG Wrexham, LL13 9UF United Kingdom United Wockhardt UK Limited Ibuprofen WOCKHARDT UK 200 mg Coated tablet Oral use Kingdom Ash Road North IBUPROFEN TABLETS Wrexham Industrial Estate 200MG Wrexham, LL13 9UF United Kingdom United Wockhardt UK Limited Ibuprofen WOCKHARDT UK 400 mg Coated tablet Oral use Kingdom Ash Road North EXTRA STRENGTH Wrexham Industrial Estate IBUPROFEN TABLETS Wrexham, LL13 9UF 400MG United Kingdom

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Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Wockhardt UK Limited Ibuprofen WOCKHARDT UK 200 mg Coated tablet Oral use Kingdom Ash Road North IBUPROFEN CAPLETS Wrexham Industrial Estate 200MG Wrexham, LL13 9UF United Kingdom United Wrafton Laboratories Ibuprofen lysine WRAFTON LABS 342 mg Tablet Oral use Kingdom Limited MIGRAINE RELIEF Exeter Road TABLETS 342MG Wrafton Braunton Devon EX33 2DL United Kingdom United Wrafton Laboratories Ibuprofen lysine WRAFTON LABS 342 mg Film-coated tablet Oral use Kingdom Limited IBUPROFEN PERRIGO Exeter Road FILM-COATED TABLETS Wrafton 200MG Braunton Devon EX33 2DL United Kingdom

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Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

United Wrafton Laboratories Ibuprofen lysine WRAFTON LABS 684 mg Film-coated tablet Oral use Kingdom Limited IBUPROFEN PERRIGO Exeter Road TABLETS 400 MG Wrafton Braunton Devon EX33 2DL United Kingdom United Medley Pharma Limited Ibuprofen Medley Pharma 200 mg Coated tablet Oral use Kingdom Unit 2A, Olympic Way, Ibuprofen Tablets Sefton Business Park 200mg Bootle, Liverpool L30 1RD United Kingdom United Medley Pharma Limited Ibuprofen Medley Pharma 400 mg Coated tablet Oral use Kingdom Unit 2A, Olympic Way, Ibuprofen Tablets Sefton Business Park 400mg Bootle, Liverpool L30 1RD United Kingdom United Gebro Pharma GmbH Dexibuprofen SERACTIL TABLETS 300 mg Film-coated tablet Oral use Kingdom A- 6391 Fieberbrunn 300MG Austria United Gebro Pharma GmbH Dexibuprofen SERACTIL TABLETS 400 mg Film-coated tablet Oral use Kingdom A- 6391 Fieberbrunn 400MG Austria

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Member Marketing authorisation INN Invented name Strength Pharmaceutical Route of State holder form administration (in EEA)

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Annex II

Scientific conclusions and grounds for variation to the terms of the marketing authorisations

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Scientific conclusions and grounds for variation to the terms of the marketing authorisations

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) used for the reduction of inflammation, pain and fever. It is commonly used and is widely available without prescription, typically at doses ≤1200mg daily, to treat a range of conditions including pain, fever, rheumatic conditions and minor ailments. Ibuprofen is also prescribed for the chronic management of rheumatic conditions such as osteoarthritis (typically doses higher than 1200mg daily).

Ibuprofen contains equal quantities of R(-)-ibuprofen and S(+)-ibuprofen. As it is the S(+)-enantiomer which confers the anti-inflammatory and analgesic activity and not the R(-)-enantiomer, dexibuprofen which contains only S(+)-ibuprofen is also available as a medicinal product. The approved indications for dexibuprofen are similar to those for ibuprofen.

The cardiovascular (CV) risk of NSAIDs, including ibuprofen, has been kept under close review over the past years. A previous review conducted in 2006 concluded that NSAIDs as a class were associated with an increased risk of arterial thrombotic events, although the risk was considered to be higher for selective cyclooxygenase-2 (COX-2) inhibitors (also known as coxibs). Clinical trial data at that time suggested that ibuprofen at a high dose (2400 mg daily) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies did not suggest that ibuprofen at low doses (≤1200 mg daily) is associated with an increased risk of arterial thrombotic events, in particular myocardial infarction (MI)1.

Another evaluation, conducted by the CHMP in 2012, considered all available published evidence to date from epidemiological studies and also meta-analyses of clinical trials and observational studies as well as the results of the ‘safety of non-steroidal anti-inflammatory drugs’ (SOS) research project funded by the European Commission under the Seventh Framework Programme. Based on the available evidence, the review concluded, in line with previous conclusions, that ibuprofen at a high dose may be associated with an increased risk of arterial thrombotic events, and that ibuprofen at low doses is not consistently associated with an increased risk of arterial thrombotic events2.

Since the 2012 review, the Coxib and traditional NSAID Triallists’ (CNT) collaborative group published results from a large meta-analysis of more than 600 randomised clinical trials. The results suggested that the cardiovascular risk with high dose ibuprofen (2400mg) may also be similar to COX-2 inhibitors3.

In light of the above, and given the widespread use of ibuprofen, UK considered that it is in the interest of the Union to refer ibuprofen and dexibuprofen containing products for systemic use to the PRAC and request, that it gives its recommendation under Article 31 of Directive 2001/83/EC, on whether the new evidence on the risk of thrombotic events when used at high doses, doses at or above 2400mg per day, in adults and new evidence on interaction with low-dose acetylsalicylic acid require any updates to the advice to healthcare professionals and patients including warnings or contraindications as expressed in the current ibuprofen product information, or whether any other regulatory measure would be needed.

1 Information on the review conducted in 2006 can be found at http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/01/WC500054344.pdf 2 Information on the review conducted in 2012 can be found at http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/11/WC500134717.pdf 3 Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Coxib and traditional NSAID Trialists' (CNT) Collaboration. The Lancet - 30 May 2013

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The scope of the procedure included medicinal products containing (racemic) ibuprofen and dexibuprofen (S(+)-ibuprofen). Although there is very little data available regarding the arterial thrombotic risks of dexibuprofen or regarding a possible interaction between dexibuprofen and low- dose acetylsalicylic acid, it is reasonable to assume that dexibuprofen shares similar risks with (racemic) ibuprofen, hence its inclusion in the scope of this referral procedure.

The scope of the referral procedure included only systemic formulations (e.g. oral formulations, rectal preparations) but did not include products authorised for use solely in children or topical preparations intended for local effects with low systemic absorption (e.g. creams, gels, sprays, vaginal and ophthalmic preparations).

In the results of the CNT Collaboration’s network meta-analysis which partly triggered this review, high doses of ibuprofen (2400mg/day) significantly increased major coronary events (MCE) (MI or coronary heart disease (CHD) death) but not major vascular events (MVE) (non-fatal MI, coronary death, MI or CHD death, non-fatal stroke, stroke death, any stroke, and other vascular death). The adjusted rate ratio for ibuprofen vs placebo for MCE and MVE were 2.22 (1.10-4.48) and 1.44 (0.89- 2.33), respectively. In the coxib vs ibuprofen comparisons the rate ratios favoured coxibs for both MCE and MVE (i.e. slightly increased risk with ibuprofen vs coxibs group) but these were not statistically significant.

In the initial PRAC consideration of the CNT collaboration network meta-analyses, a number of important questions regarding statistical methodology were raised which were considered to limit the interpretation of the results in particular for the traditional NSAIDs (tNSAIDs), including ibuprofen. Consequently, further clarifications from the CNT Collaboration were requested around the use of indirect comparisons for tNSAIDs, the handling of zero event trials and shorter than average follow-up for ibuprofen trials that could bias the results upwards for ibuprofen.

The CNT Collaboration’s responses to the PRAC questions confirmed that zero event trials and possible unequal randomisation are unlikely to have introduced any significant bias to the results of the network meta-analysis for ibuprofen. The responses also confirmed that there is very little randomised evidence directly comparing ibuprofen to placebo and that the results of the network meta-analysis are primarily derived from studies that directly compared coxibs with ibuprofen. The PRAC was of the view that this makes it difficult to judge the size of any biases which may have been introduced by any differences in study population and study duration.

The CNT Collaboration’s responses also confirmed that the trials that compared ibuprofen with placebo were shorter in duration than the trials that compared ibuprofen with coxibs and thus there is the possibility that including the trials that compared ibuprofen with placebo in the network meta-analysis could inflate the treatment effect. The data provided by ibuprofen vs placebo trials are too limited to draw any conclusions on the risk.

Given the outstanding uncertainties regarding the size of potential biases in the network meta-analysis and the paucity of information available directly comparing ibuprofen with placebo, the PRAC was of the view that any conclusions on the magnitude of the CV risk of ibuprofen drawn from this meta- analysis should be based on the results of studies that compared ibuprofen with coxibs and not the indirect comparisons derived from the network meta-analysis.

Overall, the PRAC was of the opinion that the data from the coxib vs ibuprofen trials indicate that the CV risks of high dose ibuprofen may be similar to that for coxibs.

Several other data sources informed the recommendation of the PRAC, including available data from previous reviews, clinical studies, published literature as well as data submitted by marketing authorisation holders (MAHs) of medicinal products containing ibuprofen or dexibuprofen.

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The PRAC was of the opinion that clinical trial data suggest that high daily doses of ibuprofen (2400mg/day) are associated with an increased risk of cardiovascular events (MI, stroke), which may be similar to that observed with coxibs or diclofenac. The review of the updated epidemiological data confirms the findings of previous EU reviews and does not suggest that ibuprofen at low doses (≤1200mg/day) is associated with an increased risk of cardiovascular events.

The PRAC noted that there are no or limited data on the arterial thrombotic risk of ibuprofen at doses between 1200mg and 2400mg/day and so it cannot be determined exactly how the risk changes over this dosage range. However the PRAC considered that it is likely that there is a dose-dependent increase in risk with increasing doses between 1200mg and 2400mg/day.

The effect of ibuprofen treatment duration on cardiovascular risk has not been extensively studied and is therefore uncertain.

Cardiovascular risk may be higher in patients with cardiovascular disease, and high ibuprofen doses should be avoided in this population. Similarly, high daily doses should not be recommended to patients with risk factors for cardiovascular disease.

The PRAC considered that, in general terms, the current product information of ibuprofen-containing products already contains meaningful information regarding cardiovascular risks. However, the information about the use of high ibuprofen doses in certain populations with pre-existing cardiovascular disease and/or risk factors for arterial thrombotic events merits further clarification and thus updates should be made to section 4.4 and 4.8.

Although no specific data about cardiovascular risk of dexibuprofen are available, a similar cardiovascular risk to that of high-dose of ibuprofen is expected when dexibuprofen is used at equipotent doses. The data submitted by the MAHs widely supported the definition of dexibuprofen high dose as 50% of the high dose of ibuprofen. The PRAC concluded that dexibuprofen product information should be amended in the same way as ibuprofen product information.

Regarding the interaction between ibuprofen and acetylsalicylic acid, the PRAC was of the opinion that new pharmacodynamic and epidemiological data investigating a possible interaction between ibuprofen and acetylsalicylic acid are consistent with the conclusions of the previous EU-wide review of this issue – that whilst pharmacodynamic studies show that ibuprofen inhibits the antiplatelet effect of acetylsalicylic acid when it is administered concurrently, the clinical implications of such an interaction are still uncertain. The PRAC further concluded that the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded.

The PRAC was of the view that updates should be made to section 4.5 and 5.1 to reflect current data on the potential clinical effect of the pharmacodynamic interaction when ibuprofen is taken with acetylsalicylic acid.

There are limited available data on a potential interaction between dexibuprofen and acetylsalicylic acid. However, the results of a single pharmacodynamic study submitted by one of the MAHs in response to the PRAC questions suggest that dexibuprofen also reduces the antiplatelet effect of acetylsalicylic acid ex vivo. The PRAC was of the view that any update to the ibuprofen product information should also be applied to the product information for dexibuprofen, taking into consideration any dexibuprofen specific details, e.g. equipotent dose.

The recommendation for update of the product information should be applicable to all medicinal products containing ibuprofen and dexibuprofen, regardless of maximum recommended daily dose.

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Having noted all of the above, the PRAC concluded that the benefit-risk balance for ibuprofen and dexibuprofen containing medicinal products (systemic formulations) remains favourable subject to the agreed changes to the product information.

Overall conclusion and grounds for the variation to the terms of the marketing authorisations

Whereas,

• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for ibuprofen- and dexibuprofen-containing medicinal products (systemic formulations).

• The PRAC considered the totality of the data available in relation to the cardiovascular risk of ibuprofen- and dexibuprofen-containing medicinal products and in relation to the potential interaction between ibuprofen/dexibuprofen and acetylsalicylic acid, acknowledging the conclusions from previous reviews, the submissions by marketing authorisation holders, and additional data from independent researchers.

• The PRAC considered that with regard to the arterial thrombotic risks of ibuprofen, the data available to date from randomised clinical trials, observational studies and individual epidemiological studies, including meta-analysis thereof, supports that ibuprofen at high doses (2400mg or above per day) is associated with an increased risk of arterial thrombotic events. It was observed that this risk may be similar to that of selective COX-2 inhibitors. The available data do not suggest that ibuprofen at low doses (equal to or below 1200mg per day) is associated with an increased risk of arterial thrombotic events.

• The PRAC considered that although no specific data about the cardiovascular risk of dexibuprofen are available, a similar cardiovascular risk to that of high-dose of ibuprofen is expected when dexibuprofen is used at equipotent doses.

• The PRAC considered that with regard to the interaction between ibuprofen/dexibuprofen and acetylsalicylic acid the pharmacodynamic studies available to date show that ibuprofen/dexibuprofen inhibit the antiplatelet effect of acetylsalicylic acid when it is administered concurrently. The epidemiological data available to date, however, do not demonstrate a clinically significant interaction but the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded.

• The PRAC considered that in general terms, the current product information of ibuprofen- and dexibuprofen-containing products already contains meaningful information regarding cardiovascular risks and pharmacodynamic interaction with acetylsalicylic acid. However, the PRAC concluded that information about the risks associated with the use of high doses of ibuprofen/dexibuprofen in certain populations with pre-existing cardiovascular disease and/or risk factors for arterial thrombotic events merits further clarification, as well as some additional information on the potential clinical effect of the pharmacodynamic interaction when taken with acetylsalicylic acid.

The PRAC concluded that the benefit-risk balance for ibuprofen- and dexibuprofen-containing medicinal products (systemic formulations) remains favourable subject to the agreed changes to the product information.

Therefore, the PRAC recommended the variation to the terms of the marketing authorisation for all medicinal products referred to in Annex I and for which the amendments of the relevant sections of the

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summary of product characteristics and package leaflet are set out in Annex III of the PRAC recommendation.

CMDh agreement The CMDh, having considered the PRAC recommendation dated 10 April 2015 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC agrees with the overall scientific conclusions by the PRAC and to the variation to the terms of the marketing authorisations of medicinal products containing ibuprofen or dexibuprofen (systemic formulations) as set out in Annex III.

The timetable for the implementation of the agreement is set out in Annex IV.

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Annex III

Amendments to relevant sections of the summary of product characteristics and package leaflet

Note:

These amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are the outcome of the referral procedure.

The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.

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For all ibuprofen-containing products

A. Summary of Products Characteristics

Section 4.2 - Posology and method of administration

[The section should be amended to reflect the following wording]

[…]

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

[…]

Section 4.3 - Contraindications

[The section should be amended to reflect the following wording]

[…]

Severe heart failure (NYHA Class IV)

[…]

Section 4.4 - Special warnings and precautions for use

[The section should be amended to reflect the following wording]

[…]

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.

Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.

[…]

Section 4.5 - Interactions with other medicinal products and other forms of interaction

[The section should be amended to reflect the following wording]

[…] Acetylsalicylic acid Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid

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cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

[…]

Section 4.8 - Undesirable effects

[The section should be amended to reflect the following wording]

[…]

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

[…]

Section 5.1 - Pharmacodynamic properties

[The section should be amended to reflect the following wording]

[…]

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg were taken within 8 h before or within 30 min after immediate release acetylsalicylic acid dosing (81 mg), a decreased effect of acetylsalicylic acid on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).

[…]

B. Package Leaflet

Section 2 - What you need to know before you take [Invented name]

[…]

Warnings and precautions

[The section should be amended to reflect the following wording]

[…]

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking [Invented name] if you:

- have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).

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- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker. […]

Other medicines and [Invented name] [The section should be amended to reflect the following wording]

[…]

[Invented name] may affect or be affected by some other medicines. For example:

[…]

- medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)

- medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

[…]

Some other medicines may also affect or be affected by the treatment of [Invented name]. You should therefore always seek the advice of your doctor or pharmacist before you use [Invented name] with other medicines.

[…]

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For all dexibuprofen-containing products

A. Summary of Products Characteristics

Section 4.2 - Posology and method of administration

[The section should be amended to reflect the following wording]

[…]

The dosage should be adjusted to the severity of the disorder and the complaints of the patient. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

[…]

Section 4.3 - Contraindications

[The section should be amended to reflect the following wording]

[…]

Severe heart failure (NYHA Class IV)

[…]

Section 4.4 - Special warnings and precautions for use

[The section should be amended to reflect the following wording]

[…]

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events. Although there are limited data on the arterial thrombotic risk of dexibuprofen, it is reasonable to assume that the risk with high dose dexibuprofen (1200 mg/day) would be similar to that associated with high dose ibuprofen (2400 mg/day).

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with dexibuprofen after careful consideration and high doses (1200 mg/day) should be avoided.

Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of dexibuprofen (1200 mg/day) are required.

[…]

Section 4.5 - Interactions with other medicinal products and other forms of interaction

[The section should be amended to reflect the following wording (if sub-sections exist this wording should be included in the relevant sub-section, e.g. concomitant use not recommended)]

[…]

380

Acetylsalicylic acid

Concomitant administration of dexibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1). Whilst there are no data available for dexibuprofen, it is reasonable to assume that a similar interaction may exist between dexibuprofen (= S(+)-ibuprofen) (which is the pharmacologically active enantiomer of ibuprofen) and low-dose acetylsalicylic acid.

[…]

Section 4.8 - Undesirable effects

[The section should be amended to reflect the following wording]

[…]

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). Although there are limited data on the arterial thrombotic risk of dexibuprofen, it is reasonable to assume that the risk with high dose dexibuprofen (1200 mg/day) would be similar to that associated with high dose ibuprofen (2400 mg/day).

[…]

Section 5.1 - Pharmacodynamic properties

[The section should be amended to reflect the following wording]

[…]

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg were taken within 8 h before or within 30 min after immediate release acetylsalicylic acid dosing (81 mg), a decreased effect of acetylsalicylic acid on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5). Whilst there are no data available for dexibuprofen, it is reasonable to assume that a similar interaction may exist between dexibuprofen (= S(+)-ibuprofen) (the pharmacologically active enantiomer of ibuprofen) and low-dose acetylsalicylic acid.

[…]

B. Package Leaflet

Section 2 - What you need to know before you take [Invented name]

[…]

381

Warnings and precautions

[The section should be amended to reflect the following wording]

[…]

Anti-inflammatory/pain-killer medicines like dexibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking [Invented name] if you:

- have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).

- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker. […]

Other medicines and [Invented name] [The section should be amended to reflect the following wording]

[…]

[Invented name] may affect or be affected by some other medicines. For example:

[…]

- medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)

- medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

[…]

Some other medicines may also affect or be affected by the treatment of [Invented name]. You should therefore always seek the advice of your doctor or pharmacist before you use [Invented name] with other medicines. […]

382

Annex IV

Timetable for the implementation of the agreement

383

Timetable for the implementation of the agreement

Adoption of CMDh agreement: May 2015 CMDh meeting

Transmission to National Competent Authorities of 17 June 2015 the translations of the annexes to the agreement:

Implementation of the agreement by the Member 16 October 2015 States (submission of the variation type IB by the Marketing Authorisation Holder):

384