Annex I

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States

1

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

Belgium Laboratoires SMB SA Paracetamol/ Algocod 500 mg/30 mg effervescent oral use rue de la Pastorale 26- Codeine phosphate tablet 28 hemihydrate 1080 Brussels Belgium Belgium Laboratoires SMB SA Paracetamol/ Algocod 500 mg/30 mg powder for oral oral use rue de la Pastorale 26- Codeine phosphate solution 28 hemihydrate 1080 Brussels Belgium Belgium Bristol-Meyers Squibb Paracetamol/ Dafalgan codeine 500 mg/30 mg effervescent oral use Belgium sa Codeine phosphate tablet Chaussée de la Hulpe hemihydrate 185 1170 Brussels Belgium Belgium Bristol-Meyers Squibb Paracetamol/ Dafalgan codeine 500 mg/30 mg film-coated tablet oral use Belgium sa Codeine phosphate Chaussée de la Hulpe hemihydrate 185 1170 Brussels Belgium Belgium Aktuapharma nv Paracetamol/ Dafalgan codeine 500 mg/30 mg tablet oral use Ambachtenlaan 13E Codeine phosphate 3001 Leuven hemihydrate Belgium Belgium Sterop Laboratoires nv Paracetamol Nevrine codeine 500 mg tablet oral use Avenue de Scheut 46- Caffeine 50 mg 50 Codeine phosphate 30 mg 1070 Brussels hemihydrate Belgium

2

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Belgium Glaxosmithkline Paracetamol/ Panadol codeine 500 mg/30 mg tablet oral use Consumer Healthcare Codeine phosphate sa hemihydrate Site Apollo, Avenue 2-4-6, 1300 Wavre Belgium Belgium Teva Pharma Belgium Paracetamol/ Paracetamol codeine 500 mg/30 mg dispersible tablet oral use Laarstraat 16 Codeine phosphate teva 2610 Wilrijk hemihydrate Belgium Belgium Mylan BVBA/SPRL Paracetamol/ Paracodmylan 500 mg/30 mg tablet oral use Terhulpsesteenweg Codeine phosphate 6A, hemihydrate B-1560 Hoeilaart Belgium Bulgaria Actavis EAD Acetylsalicylic acid/ Aceffein 250 mg/50 mg/ 10 tablet oral use 29 Atanas Dukov Str. Caffeine/ mg/ 250 mg + Sofia 1407 Codeine phosphate/ Bulgaria Paracetamol Bulgaria Unipharm JSC Metamizole sodium/ Paracofdal 300 mg/ 200 mg/ 30 tablet oral use Traiko Stanoev str. № Paracetamol/ mg/20 mg 3 + Sofia 1797 Caffeine/ Bulgaria Codiene phosphate Bulgaria Omega Pharma Paracetamol/ Solpadeine 500 mg/ 8 mg/ 30 soluble tablet oral use Limited Codeine Phosphate mg Vauxhall Bridge Road Hemihydrate/ London Caffeine SW1V 2SA United Kingdom Bulgaria Omega Pharma Paracetamol/ Solpadeine 500 mg/ 8 mg/ 30 capsule, hard oral use Limited Codeine Phosphate mg Vauxhall Bridge Road Hemihydrate/ London Caffeine SW1V 2SA United Kingdom

3

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Cyprus Multi-Pharm Co Ltd, 22 Paracetamol/ TALVOSILEN TABLET 500mg/20mg tablet oral use Philopimenos Str, Codeine phosphate P.O.Box 59522 Lemesos 4010 Cyprus Cyprus Multi-Pharm Co Ltd, 22 Paracetamol/ TALVOSILEN FORTE 1000mg/60mg suppository rectal use Philopimenos Str, Codeine phosphate SUPPOSITORY P.O.Box 59522 Lemesos 4010 Cyprus Cyprus Multi-Pharm Co Ltd, 22 Paracetamol/ TALVOSILEN FORTE 500mg/30mg tablet oral use Philopimenos Str, Codeine phosphate TABLET P.O.Box 59522 Lemesos 4010 Cyprus Cyprus C A Papaellina & Co ltd Paracetamol/ SOLPADEINE SOLUBLE 500mg/8mg/30mg effervescent oral use 179 Yiannos Codeine Phosphate TABLET tablet Kranidiotis Hemihydrate/ ave., P.O.Box 24018 Caffeine Lefkosia 2235 Cyprus Cyprus C A Papaellina & Co ltd Paracetamol/ SOLPADEINE TABLET 500mg/8mg/30mg tablet oral use 179 Yiannos Codeine Phosphate Kranidiotis Hemihydrate/ ave., P.O.Box 24018 Caffeine Lefkosia 2235 Cyprus Cyprus Aegis Ltd, 17 Athinon Paracetamol/ PARCOTEN TABLET 500mg/10mg tablet oral use Street, Ergates Codeine phosphate Industrial Area, P.O.Box 28629 Lefkosia Cyprus

4

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Cyprus Boehringer Ingelheim Paracetamol+ caffeine+ LONARID N 400mg+50mg+20m suppository rectal use Hellas SA codeine phosphate SUPPOSITORY g 2 Ellinikou Str hemihydrate 16777,Elliniko, Athens Greece Cyprus Boehringer Ingelheim Paracetamol+ caffeine+ LONARID N TABLET 400mg+50mg+10m tablet oral use Hellas SA codeine phosphate g 2 Ellinikou Str hemihydrate 16777,Elliniko, Athens Greece Czech Zentiva a.s. Codeini phosphas CODEIN 15 mg tablet oral use Republic Einsteinova 24 hemihydricus SLOVAKOFARMA 15 MG 851 01 Bratislava Slovak Republic Czech Zentiva a.s. Codeini phosphas CODEIN 30 mg tablet oral use Republic Einsteinova 24 hemihydricus SLOVAKOFARMA 30 MG 851 01 Bratislava Slovak Republic Czech Zentiva, k.s. Codeini phosphas KORYLAN 28,73 mg + 325 mg tablet oral use Republic U kabelovny 130 hemihydricus + 102 37 Praha 10 paracetamolum Czech Republic Czech Zentiva, k.s. Codeini phosphas ULTRACOD 30 mg + 500 mg tablet oral use Republic U kabelovny 130 hemihydricus + 102 37 Praha 10 paracetamolum Czech Republic Czech bene-Arzneimittel Codeini phosphas TALVOSILEN 20 mg + 500 mg tablet oral use Republic GmbH sesquihydricus + Herterichstrasse 1 paracetamolum 814 79 München Germany Czech bene-Arzneimittel Codeini phosphas TALVOSILEN FORTE 30 mg + 500 mg capsule, hard oral use Republic GmbH hemihydricus + Herterichstrasse 1 paracetamolum 814 79 München Germany

5

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Czech GlaxoSmithKline Codeini phosphas PANADOL ULTRA 8 mg + 500 mg + tablet oral use Republic Consumer Healthcare, hemihydricus + 30 mg GlaxoSmithKline paracetamolum + Export Ltd. coffeinum Great West Road 980 Brentford TW8 9GS United Kingdom Czech GlaxoSmithKline Codeini phosphas PANADOL ULTRA RAPIDE 8 mg + 500 mg + effervescent oral use Republic Consumer Healthcare, hemihydricus + 30 mg tablet GlaxoSmithKline paracetamolu + Export Ltd. coffeinum Great West Road 980 Brentford TW8 9GS United Kingdom Czech Zentiva, k.s. Codeini phosphas SPASMOPAN 19,2 mg + 500 mg suppository rectal use Republic U kabelovny 130 hemihydricus + + 10 mg + 0,1 mg 102 37 Praha 10 - paracetamolum + Dolní Měcholupy pitofenoni Czech Republic hydrochloridum + fenpiverinii bromidum Denmark Alternova A/S, Codeine Kodein "Alternova" 25 mg film-coated tablet oral use Lodshusvej 11, DK- 4230 Skælskør, Denmark Denmark Takeda Pharma A/S, Salicylamide + Codeine Kodamid ”DAK” 250 mg + 9,6 mg + tablet oral use Langebjerg 1, DK- + Caffeine + 50 mg + 150 mg 4000 Roskilde Propyphenazone Denmark Denmark Takeda Pharma A/S, Codeine Kodein "DAK" 25 mg film-coated tablet oral use Langebjerg 1, DK- 4000 Roskilde Denmark Denmark Takeda Pharma A/S, Codeine Kodein "DAK" 3 mg/ml oral solution oral use Langebjerg 1, DK- 4000 Roskilde Denmark

6

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Denmark Takeda Pharma A/S, ASA + codeine Kodimagnyl "DAK" 500 mg + 10 mg effervescent oral use Langebjerg 1, DK- tablet 4000 Roskilde Denmark Denmark Takeda Pharma A/S, Codeine Kodein Stærk "DAK" 8 mg/ml oral solution oral use Langebjerg 1, DK- 4000 Roskilde Denmark Denmark Takeda Pharma A/S, ASA + codeine Kodimagnyl "DAK" 500 mg + 9,6 mg tablet oral use Langebjerg 1, DK- 4000 Roskilde Denmark Denmark Takeda Pharma A/S, ASA + codeine Kodimagnyl Ikke- 500 mg + 9,6 mg film-coated tablet oral use Langebjerg 1, DK- stoppende "DAK" 4000 Roskilde Denmark Denmark Takeda Pharma A/S, Codeine + paracetamol Kodipar 30,6 mg + 500 mg film-coated tablet oral use Langebjerg 1, DK- 4000 Roskilde Denmark Denmark Amgros I/S, Codeine Kodein "SAD" 25 mg tablet oral use Dampfærgevej 22, DK-2100 København Ø, Denmark Estonia GlaxoSmithKline Paracetamol/Codeine/C SOLPADEINE SOLUBLE 500 mg/8 mg/30 mg effervescent oral use Export Ltd 980 Great affeine tablet West Road Brentford Middlesex TW8 9GS United Kingdom Estonia Zentiva, k.s. Codeine/Paracetamol ALGOCALM 30mg/500mg tablet oral use U Kabelovny 130 Dolni Mecholupy 102 37 Prague 10 Czech Republic

7

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Estonia GlaxoSmithKline Paracetamol/Codeine/C SOLPADEINE 500 mg/8 mg/30 mg tablet oral use Export Ltd 980 Great affeine West Road Brentford Middlesex TW8 9GS United Kingdom Estonia Vitabalans Oy Codeine/Paracetamol PARACETAMOL/CODEINE 30mg/500mg tablet oral use Varastokatu 8, VITABALANS 13500 Hämeenlinna Finland Estonia Actavis UK Limited Paracetamol/Codeine CO-CODAMOL 500mg/8mg tablet oral use Whiddon Valley, Barnstaple, Devon, EX32 8NS United Kingdom Finland Oy Leiras Takeda Codeine phosphate PAMOL COD 30 mg effervescent oral use Paciuksenkatu 21 Paracetamol 500 mg tablet PL 1406 00101 Helsinki Finland Finland Sanofi-aventis Oy Codeine phosphate PANACOD 30 mg tablet oral use Huopalahdentie 24 Paracetamol 500 mg PL 22 00351 Helsinki Finland Finland Sanofi-aventis Oy Codeine phosphate PANACOD 30 mg effervescent oral use Huopalahdentie 24 Paracetamol 500 mg tablet PL 22 00351 Helsinki Finland Finland Bene-Arzneimittel Codeine phosphate PARACETAMOL/CODEIN 30 mg tablet oral use GmbH Paracetamol BENE.ARZNEIMITTEL 500 mg Herterichstrasse 1 81479 MÜNCHEN Germany

8

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Finland Vitabalans Oy Codeine phosphate PARAMAX-COD 30 mg tablet oral use Varastokatu 8 Paracetamol 500 mg 13500 HÄMEENLINNA Finland France EG LABO - Paracetamol/Codeine PARACETAMOL CODEINE 500 mg/30 mg effervescent oral use Laboratoires EG 500 mg/30 mg, tablet EuroGenerics comprimé effervescent "Le Quintet" - sécable bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France France Societe Cilfa Paracetamol/Codeine SEDARENE, gélule 300 mg/10 mg capsule oral use Developpement 20, Rue Jean Daudin 75015 – Paris France France Sanofi-Aventis Paracetamol/Codeine CODOLIPRANE ADULTES 400 mg/20 mg tablet oral use France 1-13, 400 mg/20 mg, Boulevard Romain comprimé sécable Rolland 75014 Paris France France Bayer Sante Paracetamol/Codeine CLARADOL CODEINE 500 mg/20 mg tablet oral use Familiale 33, Rue 500 mg/20 mg, De L'industrie comprimé 74240 Gaillard France France Sanofi-Aventis Paracetamol/Codeine CODOLIPRANE ENFANTS 400 mg/20 mg tablet oral use France 1-13, 400 mg/20 mg, Boulevard Romain comprimé sécable Rolland 75014 Paris France

9

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

France Sanofi-Aventis Paracetamol/Codeine CODOLIPRANE 500 500 mg/30 mg effervescent oral use France 1-13, mg/30 mg, comprimé tablet Boulevard Romain effervescent sécable Rolland 75014 Paris France France Pierre Fabre Paracetamol/Codeine KLIPAL CODEINE 600 600 mg/50 mg tablet oral use Medicament mg/50 mg, comprimé 45, Place Abel Gance 92654 Boulogne Cedex France France Bouchara Recordati Codeine CODENFAN 1 mg/ml, 1 mg/ml syrup oral use 68, Rue Marjolin sirop Bp 67 92302 Levallois- Perret Cedex France France Arrow Generiques Paracetamol/Codeine PARACETAMOL CODEINE 500 mg/30 mg effervescent oral use 26, avenue Tony ARROW 500 mg/30 mg, tablet Garnier comprimé effervescent 69007 Lyon sécable France France Gifrer Barbezat8 Paracetamol/Codeine COMPRALGYL 400 400 mg/20 mg tablet oral use 10, Rue Paul Bert mg/20 mg, comprimé Bp 165 sécable 69151 Décines Cedex France France Pierre Fabre Paracetamol/Codeine KLIPAL CODEINE 300 300 mg/25 mg tablet oral use Medicament mg/25 mg, comprimé 45, Place Abel Gance 92654 Boulogne Cedex France

10

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) France Teva Sante Paracetamol/Codeine PARACETAMOL CODEINE 500 mg/30 mg effervescent oral use 110, Esplanade du TEVA 500 mg/30 mg, tablet Général de Gaulle comprimé effervescent 92931 Paris La sécable Défense Cedex France

France Sanofi-Aventis Paracetamol/Codeine PARACETAMOL CODEINE 500 mg/30 mg effervescent oral use France 1-13, SANOFI-AVENTIS tablet Boulevard Romain FRANCE 500 mg/30 mg, Rolland comprimé effervescent 75014 Paris sécable France France SANDOZ Paracetamol/Codeine PARACETAMOL CODEINE 500 mg/30 mg effervescent oral use 49, avenue Georges SANDOZ 500 mg/30 mg, tablet Pompidou comprimé effervescent 92300 Levallois-Perret sécable France France Biogaran Paracetamol/Codeine PARACETAMOL CODEINE 500 mg/30 mg effervescent oral use 15, boulevard Charles ALMUS 500 mg/30 mg, tablet de Gaulle comprimé effervescent 92700 Colombes sécable France France Cristers Paracetamol/Codeine PARACETAMOL CODEINE 500 mg/30 mg effervescent oral use 22 quai Gallieni CRISTERS 500 mg/30 tablet 92150 Suresnes mg, comprimé France effervescent sécable France Biogaran Paracetamol/Codeine PARACETAMOL CODEINE 500 mg/30 mg effervescent oral use 15, boulevard Charles BIOGARAN 500 mg/30 tablet de Gaulle mg, comprimé 92700 Colombes effervescent sécable France France Mylan Sas Paracetamol/Codeine PARACETAMOL CODEINE 500 mg/30 mg effervescent oral use 117, allée des Parcs MYLAN 500 mg/30 mg, tablet 69800 Saint-Priest comprimé effervescent France sécable

11

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) France Bristol Myers Squibb - Paracetamol/Codeine DAFALGAN CODEINE, 500 mg/30 mg effervescent oral use 3, rue Joseph Monier comprimé effervescent tablet 92500 Rueil- sécable Malmaison France France Bristol Myers Squibb - Paracetamol/Codeine DAFALGAN CODEINE, 500 mg/30 mg coated tablet oral use 3, rue Joseph Monier comprimé pelliculé 92500 Rueil- Malmaison France France Elaiapharm Paracetamol/Codeine COPRALGIR 400 mg/20 400 mg/20 mg coated tablet oral use 2881, Route des mg, comprimé sécable Crêtes BP 205 Valbonne 06904 Sophia Antipolis Cedex France France Merck Medication Paracetamol/Codeine GAOSEDAL CODEINE, 500 mg/20 mg tablet oral use Familiale comprimé 37, rue Saint-Romain 69379 Lyon Cedex 08 France France Meda Pharma (France) Paracetamol/Codeine ALGISEDAL, comprimé 400 mg/25 mg, tablet oral use 25 boulevard de l'amiral bruix 75016 Paris France France Pharmastra Codeine (Chlorhydrate NOVACETOL (ASPIRINE 10,0 mg / 300,0 tablet oral use 2c, rue du marchal de) /acétylsalicylique PARACETAMOL), mg/187,5 mg/ 65,1 de lattre de tassigny (acide)/ comprimé mg 67460 paracétamol/paracétam Souffelweyersheim ol granulé 96 France

12

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Germany ALIUD PHARMA GmbH codeinphosphat- Paracetamol AL comp. 30 mg tablet oral use Gottlieb-Daimler-Str. hemihydrat 19 paracetamol 500 mg 89150 Laichingen Germany Germany Aristo Pharma GmbH codeinphosphat- Azur compositum 40 mg suppository rectal use Wallenroder Str. 8-10 hemihydrat 13435 Berlin coffein 50 mg Germany paracetamol 600 mg Germany Aristo Pharma GmbH codeinphosphat- Azur compositum 30 mg tablet oral use Wallenroder Str. 8-10 hemihydrat 13435 Berlin coffein 50 mg Germany paracetamol 350 mg

Germany Aristo Pharma GmbH codeinphosphat- Azur compositum SC 30 mg tablet oral use Wallenroder Str. 8-10 hemihydrat 13435 Berlin paracetamol 500 mg Germany Germany Aristo Pharma GmbH codeinphosphat- Azur compositum SC 60 mg suppository rectal use Wallenroder Str. 8-10 hemihydrat Suppositorien 13435 Berlin paracetamol 1000 mg Germany Germany Astellas Pharma GmbH codeinphosphat- Dolomo TN 30 mg tablet oral use Gearg-Brauchle-Ring hemihydrat 64-66 paracetamol 250 mg 80992 München acetylsalicylsäure 250 mg Germany coffein 50 mg

Germany bene - Arzneimittel codeinphosphat- Paracetamol/Codein 500 30 mg suppository rectal use GmbH hemihydrat mg/30 mg bene Herterichstr. 1 - 3 paracetamol 500 mg 81479 München Germany

13

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Germany bene - Arzneimittel codeinphosphat- talvosilen 20 mg tablet oral use GmbH hemihydrat Herterichstr. 1 - 3 paracetamol 500 mg 81479 München Germany Germany bene - Arzneimittel codeinphosphat- talvosilen 20 mg capsule oral use GmbH hemihydrat Herterichstr. 1 - 3 paracetamol 500 mg 81479 München Germany Germany bene - Arzneimittel codeinphosphat- talvosilen 1000 mg/20 20 mg suppository rectal use GmbH hemihydrat mg Zäpfchen Herterichstr. 1 - 3 paracetamol 1000 mg 81479 München Germany Germany bene - Arzneimittel codeinphosphat- talvosilen 250 mg/5 mg 5 mg suppository rectal use GmbH hemihydrat Zäpfchen Herterichstr. 1 - 3 paracetamol 250 mg 81479 München Germany Germany bene - Arzneimittel codeinphosphat- talvosilen 500 mg/10 mg 10 mg suppository rectal use GmbH hemihydrat Zäpfchen Herterichstr. 1 - 3 paracetamol 500 mg 81479 München Germany Germany bene - Arzneimittel codeinphosphat- talvosilen 500 mg/30 mg 30 mg suppository rectal use GmbH hemihydrat Herterichstr. 1 - 3 paracetamol 500 mg 81479 München Germany Germany bene - Arzneimittel codeinphosphat- talvosilen forte 30 mg capsule, hard oral use GmbH hemihydrat Herterichstr. 1 - 3 paracetamol 500 mg 81479 München Germany

14

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Germany bene - Arzneimittel codeinphosphat- talvosilen forte 60 mg suppository rectal use GmbH hemihydrat Herterichstr. 1 - 3 paracetamol 1000 mg 81479 München Germany Germany bene - Arzneimittel codeinphosphat- talvosilen forte 30 mg tablet oral use GmbH hemihydrat 500 mg Herterichstr. 1 - 3 paracetamol 81479 München Germany Germany bene - Arzneimittel codeinphosphat- talvosilen-Saft 5 mg/5ml suspension oral use GmbH hemihydrat Herterichstr. 1 - 3 paracetamol 200 mg/5ml 81479 München Germany Germany Berlin-Chemie AG codeinphosphat- Codeinum phosphoricum 30 mg tablet oral use Glienicker Weg 125 hemihydrat Berlin-Chemie 12489 Berlin Germany Germany Berlin-Chemie AG codeinphosphat- Titretta 30 mg tablet oral use Glienicker Weg 125 hemihydrat Schmerztabletten 12489 Berlin paracetamol 500 mg Germany Germany Berlin-Chemie AG codeinphosphat- Titretta Zäpfchen 60 mg suppository rectal use Glienicker Weg 125 hemihydrat 1000/60 12489 Berlin paracetamol 1000 mg Germany Germany Dr. R. Pfleger codeinphosphat- Contraneural 30 mg tablet oral use Chemische Fabrik hemihydrat Paracetamol/Codein GmbH paracetamol 500 mg Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany

15

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Germany Dr. R. Pfleger codeinphosphat- Contraneural 30 mg tablet oral use Chemische Fabrik hemihydrat Paracetamol/Codein 500 GmbH paracetamol mg/30 mg 500 mg Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany Germany Dr. R. Pfleger codeinphosphat- Optipyrin 60 mg suppository rectal use Chemische Fabrik hemihydrat GmbH paracetamol 1000 mg Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany Germany MEDA Manufacturing codeinphosphat- Dolviran N 30 mg tablet oral use GmbH hemihydrat Neurather Ring 1 acetylsalicylsäure 500 mg 51063 Köln Germany Germany Merck Serono GmbH codeinphosphat- Nedolon P 30 mg tablet oral use Alsfelder Str. 17 hemihydrat 64289 Darmstadt paracetamol 500 mg Germany Germany Novartis Pharma codeinphosphat- Combaren 50 mg/50 mg 50 mg film-coated tablet oral use GmbH hemihydrat Filmtabletten Roonstr. 25 diclofenac-natrium 50 mg 90429 Nürnberg Germany Germany Novartis Pharma codeinphosphat- Voltaren Plus 50 mg/50 50 mg film-coated tablet oral use GmbH hemihydrat mg Filmtabletten Roonstr. 25 diclofenac-natrium 50 mg 90429 Nürnberg Germany

16

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Germany OPTIMED Pharma codeinphosphat- codi OPT 60 mg tablet oral use GmbH hemihydrat Alfred-Nobel-Str. 5 50226 Frechen Germany Germany Pfizer Pharma GmbH codeinphosphat- Gelonida 30 mg tablet oral use Linkstr. 10 hemihydrat Schmerztabletten 10785 Berlin paracetamol 500 mg Germany Germany Stadapharm GmbH codeinphosphat- Paracetamol comp. 30 mg tablet oral use Stadastr. 2 - 18 hemihydrat STADA 500 mg/30 mg 61118 Bad Vilbel paracetamol 500 mg Germany Germany Temmler Werke GmbH codeinphosphat- Dolomo N 30 mg tablet oral use Weihenstephaner Str. hemihydrat 28 acetylsalicylsäure 250 mg 81673 München paracetamol 250 mg Germany Greece Boehringer Ingelheim Paracetamol+ LONARID-N 400mg+50mg+20m suppository rectal use Hellas SA Caffeine+ Codeine g 2 Ellinikou Str phosphate hemihydrate 16777,Elliniko, Athens Greece Greece Boehringer Ingelheim Paracetamol+ LONARID-N 400mg+50mg+10m tablet oral use Hellas SA Caffeine+ Codeine g 2 Ellinikou Str phosphate hemihydrate 16777,Elliniko, Athens Greece Greece Boehringer Ingelheim Paracetamol+ Codeine LONALGAL 1000mg+30mg suppository rectal use Hellas SA phosphate hemihydrate 2 Ellinikou Str 16777,Elliniko, Athens Greece

17

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Greece Boehringer Ingelheim Paracetamol+ Codeine LONALGAL 500mg+30mg tablet oral use Hellas SA phosphate hemihydrate 2 Ellinikou Str 16777,Elliniko, Athens Greece Hungary GlaxoSmithKline 500 mg/8 mg/30 mg hard capsule Consumer Healthcare GSK Export Ltd. Brentford TW89GS paracetamol, codeine, United Kingdom caffeine PANADOL ULTRA Hungary GlaxoSmithKline 500 mg/8 mg/30 mg effervescent oral use Consumer Healthcare tablet GSK Export Ltd. Brentford TW89GS paracetamol, codeine, United Kingdom caffeine PANADOL ULTRA Hungary GlaxoSmithKline 500 mg/8 mg/30 mg tablet oral use Consumer Healthcare GSK Export Ltd. Brentford TW89GS paracetamol, codeine, United Kingdom caffeine PANADOL ULTRA Hungary Vitabalans Oy 500 mg/30 mg tablet oral use Varastokatu 8. Hämeenlinna 13500 Finland paracetamol, codeine, PARCODIN Hungary Bene Arzneimittel 30 mg/500 mg hard capsule oral use GmbH Herterichstrasse 1. Munich 81479 Germany codeine, paracetamol, TALVOSILEN FORTE Iceland Actavis Group hf. - Paracetamolum Pinex Comp Forte 500/30 mg suppository rectal use Reykjavikurvegur 76- INN/Codeini Phosphas 78 - 220 Hafnarfjörður Hemihydricus Iceland

18

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Ireland The Boots Company Ibuprofen/Codeine Ibuprofen and Codeine 200 mg/ 12.8 mg film-coated tablet oral use Plc, 1 Thane Road Phosphate Hemihydrate 200 mg/ 12.8 mg film- West, NG2 3AA, coated Tablets Nottingham United Kingdom Ireland Clonmel Healthcare Paracetamol, Maxilief Effervescent 500 mg, effervescent oral use Ltd, Waterford Road, Codeine Phosphate Tablets 8 mg, tablet Conmel, Co. Tipperary Hemihydrate, Paracetamol 500mg 30 mg Ireland Caffeine Codeine Phosphate Hemihydrate 8mg Caffeine 30mg Ireland Sanofi-Aventis Ireland Paracetamol Solpadol Caplets 500 500 mg tablet oral use Limited, Citywest Codeine Phosphate mg/30 mg Tablets. 30 mg Business Campus, Hemihydrate Dublin 24 Ireland Ireland Sanofi-Aventis Ireland Paracetamol Solpadol 500 mg/30 mg 500 mg effervescent oral use Limited, Citywest Codeine Phosphate Effervescent Tablets 30 mg tablet Business Campus, Hemihydrate Dublin 24 Ireland Ireland GlaxoSmithKline Paracetamol Panadeine Tablets 500mg tablet oral use Consumer Healthcare Codeine Phosphate Paracetamol 500mg 8mg (Ireland) Limited, Hemihydrate Codeine Phosphate Stonemasons Way, Hemihydrate 8mg Rathfarnham, Dublin 16, Ireland Ireland GlaxoSmithKline Paracetamol Panadeine Extra 500mg film-coated tablet oral use Consumer Healthcare Codeine Phosphate Strength Tablets 12.8mg (Ireland) Limited, Hemihydrate Paracetamol 500 mg Stonemasons Way, Codeine Phosphate Rathfarnham, Dublin hemihydrate 12.8 mg 16, Ireland

19

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Ireland Chefaro Ireland Paracetamol Solpadeine Capsules 500mg capsule, hard oral use Limited, First Floor, Codeine Phosphate Paracetamol 500mg 8mg Block A, The Crescent Hemihydrate Codeine Phosphate 30mg Building, Northwood Caffeine Hemihydrate 8mg Office Park, Dublin 9, Caffeine 30mg Ireland

Ireland Chefaro Ireland Paracetamol Solpadeine Soluble 500mg effervescent oral use Limited, First Floor, Codeine Phosphate Tablets 8mg tablet Block A, The Crescent Hemihydrate Paracetamol 500mg 30mg Building, Northwood Caffeine Codeine Phosphate Office Park, Dublin 9, Hemihydrate 8mg Ireland Caffeine 30mg Ireland Chefaro Ireland Paracetamol Solpadeine Tablets 500mg tablet oral use Limited, First Floor, Codeine Phosphate Paracetamol 500mg, 8mg Block A, The Crescent Hemihydrate Codeine Phosphate Building, Northwood Caffeine Hemihydrate 8mg, 30mg Office Park, Dublin 9, Caffeine 30mg Ireland Ireland GlaxoSmithKline Ibuprofen Apfen Plus 200mg / 200mg film-coated tablet oral use Consumer Healthcare Codeine Phosphate 12.8mg Film-Coated 12.8mg (Ireland) Limited, Hemihydrate Tablets Stonemasons Way, Rathfarnham, Dublin 16, Ireland Ireland McNeil Healthcare Paracetamol Migraleve Pink Film- 500mg film-coated tablet oral use (Ireland) Ltd, Airton Codeine Phosphate coated Tablets. 8mg Road, Tallaght, Dublin Buclizine Hydrochloride Paracetamol 500mg 6.25mg 24 Codeine Phosphate 8mg Ireland Buclizine Hydrochloride 6.25mg Ireland McNeil Healthcare Paracetamol Migraleve Yellow Film- 500mg film-coated tablet oral use (Ireland) Ltd, Airton Codeine Phosphate coated Tablets 8mg Road, Tallaght, Dublin Paracetamol 500mg 24 Codeine phosphate 8mg Ireland

20

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Ireland McNeil Healthcare Paracetamol Migraleve Film-coated 500mg film-coated tablet oral use (Ireland) Ltd, Airton Codeine Phosphate Tablets 8mg Road, Tallaght, Dublin Buclizine Hydrochloride 6.25mg 24 Ireland Ireland UCB (Pharma) Ireland Paracetamol Tylex 30 mg / 500 mg 500mg capsule, hard oral use Limited, United Drug Codeine Phosphate Hard Capsules 30mg House, Magna Drive, Hemihydrate Magna Business Park, Citywest Road, Dublin 24 Ireland Ireland UCB (Pharma) Ireland Paracetamol Tylex 30 mg / 500 mg 500mg effervescent oral use Limited, United Drug Codeine Phosphate Effervescent Tablets. 30mg tablet House, Magna Drive, Hemihydrate Magna Business Park, Citywest Road, Dublin 24 Ireland Ireland Reckitt Benckiser Ibuprofen Nurofen Plus Tablets 200mg film-coated tablet oral use Ireland Ltd, 7 Codeine Phosphate Ibuprofen 200mg 12.8mg Riverwalk, Citywest Hemihydrate Codeine Phosphate Business Campus, Hemihydrate 12.8mg Dubin 24 Ireland Ireland SSL International plc, Paracetamol Syndol Film-coated 450 mg film-coated tablet oral use 103-105 Bath Road, Codeine phosphate Tablets 10 mg Slough, Berkshire, SL1 hemihydrate Paracetamol 450 mg 3UH, Doxylamine succinate Codeine Phosphate 5 mg United Kingdom Caffeine Hemihydrate 10 mg 30 mg Doxylamine succinate 5 mg Caffeine 30 mg

21

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Ireland Chefaro Ireland Paracetamol Veganin Plus Tablets 500mg film-coated tablet oral use Limited, First Floor, Codeine Phosphate 8mg Block A, The Crescent Caffeine 30mg Building, Northwood Office Park, Dublin 9, Ireland Ireland Galen Limited, Seogoe Paracetamol Kapake 15mg/500mg 500mg tablet oral use Industiral Estate, Codeine Phosphate Tablets 15mg Craigavon BT 63 5 UA, hemihydrate United Kingdom Ireland Galen Limited, Seogoe Paracetamol Kapake 30mg/500mg 500mg tablet oral use Industiral Estate, Codeine phosphate Tablets 30mg Craigavon BT 63 5 UA United Kingdom Ireland Bayer Limited, The Paracetamol Feminax Tablets 500mg tablet oral use Atrium, Blackthorn Codeine Phosphate 8mg Road, Dublin 18, Hyoscine Hydrobromide 100 micrograms Ireland Anhydrous caffeine 50 mg Italy Bristol-Myers Squibb paracetamol + codeine CO EFFERELGAN 500mg + 30mg effervescent oral use S.A.R.L. phosphate tablet 3 Rue Joseph Monier 92500 Rueil Malmaison France

Italy Bristol-Myers Squibb paracetamol + codeine CO EFFERELGAN 500mg + 30mg film-coated tablet oral use S.A.R.L. phosphate 3 Rue Joseph Monier 92500 Rueil Malmaison France

Italy Abiogen Pharma S.p.A. paracetamol + codeine CODAMOL 500mg + 30mg effervescent oral use Via Meucci, 36 phosphate tablet 56014 Loc. Ospedaletto - Pisa Italy

22

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Italy BOEHRINGER paracetamol + codeine LONARID 400mg + 10mg tablet oral use INGELHEIM ITALIA phosphate S.P.A. Via Lorenzini, 8 20139 Milano Italy Italy BOEHRINGER paracetamol + codeine LONARID 400mg + 20mg suppository rectal use INGELHEIM ITALIA phosphate S.P.A. Via Lorenzini, 8 20139 Milano Italy Italy BOEHRINGER paracetamol + codeine LONARID 200mg + 5mg suppository rectal use INGELHEIM ITALIA phosphate S.P.A. Via Lorenzini, 8 20139 Milano Italy Italy Aziende Chimiche paracetamol + codeine TACHIDOL 500mg + 30mg film-coated tablet oral use Riunite Angelini phosphate Francesco ACRAF S.p.A. Viale Amelia 70 00181 Roma Italy Italy Aziende Chimiche paracetamol + codeine TACHIDOL 500mg + 30mg effervescent oral use Riunite Angelini phosphate tablet Francesco ACRAF S.p.A. Viale Amelia 70 00181 Roma Italy

23

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Italy Aziende Chimiche paracetamol + codeine TACHIDOL 125 mg + 7,5 mg effervescent oral use Riunite Angelini phosphate granules Francesco ACRAF S.p.A. Viale Amelia 70 00181 Roma Italy Italy Aziende Chimiche paracetamol + codeine TACHIDOL 125/5 ml mg + syrup oral use Riunite Angelini phosphate 7,5/5 ml mg Francesco ACRAF S.p.A. Viale Amelia 70 00181 Roma Italy Italy Aziende Chimiche paracetamol + codeine TACHIDOL 500mg + 30mg film-coated tablet oral use Riunite Angelini phosphate Francesco ACRAF S.p.A. Viale Amelia 70 00181 Roma Italy Italy LABORATORI ALTER paracetamol + codeine PARACETAMOLO E 500mg + 30mg effervescent oral use S.R.L. phosphate CODEINA ALTER tablet Via Egadi, 7 20144 Milano Italy Italy Angenerico S.p.a. paracetamol + codeine 'PARACETAMOLO + 500mg + 30mg effervescent oral use Via Nocera Umbra, 75 CODEINA ANGENERICO granules 00181 Roma Italy Italy Angenerico S.p.a. paracetamol + codeine 'PARACETAMOLO + 125 mg + 7,5 mg effervescent oral use Via Nocera Umbra, 75 CODEINA ANGENERICO granules 00181 Roma Italy

24

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Italy Angenerico S.p.a. paracetamol + codeine 'PARACETAMOLO + 25 mg/ml + 1,5 syrup oral use Via Nocera Umbra, 75 CODEINA ANGENERICO mg/ml 00181 Roma Italy Italy Abiogen Pharma S.p.A. paracetamol + codeine ADOREA 500mg + 30mg film-coated tablet oral use Via Meucci, 36 56014 Loc. Ospedaletto - Pisa Italy Italy Abiogen Pharma S.p.A. paracetamol + codeine AZSHARA 500mg + 30mg film-coated tablet oral use Via Meucci, 36 56014 Loc. Ospedaletto - Pisa Italy Latvia ZENTIVA, k.s., U Paracetamolum/Codeini Ultracod 500 mg/30 mg 500 mg/30 mg tablet oral use Kabelovny 130, Dolní phosphas hemihydricus tablets Měcholupy, 102 37 Praha 10, The Czech Republic Latvia Actavis UK Ltd., Paracetamolum/Codeini Co-Codamol 500 mg/8 500 mg/8 mg tablet oral use Whiddon Valley, phosphas hemihydricus mg tablets Barnstaple, N Devon, EX32 8NS United Kingdom Latvia Omega Pharma Baltics Paracetamolum/Codeini Solpadeine Soluble 500 500 mg/8 mg/30 mg soluble tablet oral use SIA, K. Ulmana 119, phosphas mg/8 mg/30 mg soluble Marupe, LV-2167, hemihydricus/Coffeinu tablets Latvia m

Latvia Omega Pharma Baltics Paracetamolum/Codeini Solpadeine 500 mg/8 500 mg/8 mg/30 mg tablet oral use SIA, K. Ulmana 119, phosphas mg/30 mg tablets Marupe, LV-2167, hemihydricus/Coffeinu Latvia m

25

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Lithuania ZENTIVA, k.s., U Paracetamol/Codeine Ultracod 500mg/30mg tablet oral use Kabelovny 130, Dolní phosphate hemihydrate Měcholupy, 102 37 Praha 10, The Czech Republic Lithuania GlaxoSmithKline Paracetamol/Codeine/C Solpadeine 500mg/8mg/30mg soluble tablet oral use Consumer Healthcare affeine GlaxoSmithKline ExportLtd Brentford TW8 9GS United Kingdom Lithuania GlaxoSmithKline Paracetamol/Codeine/C Solpadeine 500mg/8mg/30mg tablet oral use Consumer Healthcare affeine GlaxoSmithKline ExportLtd Brentford TW8 9GS United Kingdom Luxembourg MEDA PHARMA 25 Paracetamol/Codeine Algisedal 400mg/25mg tablet oral use boulevard de l'amiral phosphate hemihydrate Bruix F-75016 Paris France Luxembourg Laboratoires SMB S.A. Paracetamol/Codeine Algocod 500mg/30mg effervescent oral use Rue de la Pastorale phosphate hemihydrate tablet 26- 28 B 1080 Bruxelles Belgium Luxembourg Laboratoires SMB S.A. Paracetamol/Codeine Algocod 500mg/30mg powder oral use Rue de la Pastorale phosphate hemihydrate 26- 28 B 1080 Bruxelles Belgium Luxembourg Bristol-Myers Squibb Paracetamol/Codeine Dafalgan codéine 500mg/30mg film-coated tablet oral use Belgium S.A. Avenue phosphate hemihydrate de Finlande, 8 B-1420 Braine-l'Alleud Belgium

26

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Luxembourg Bristol-Myers Squibb Paracetamol/Codeine Dafalgan codéine 500mg/30mg effervescent oral use Belgium S.A. Avenue phosphate hemihydrate tablet de Finlande, 8 B-1420 Braine-l'Alleud Belgium Luxembourg Meda Pharma Aspirin/Codeine Dolviran N 500mg/30mg tablet oral use GmbH&Co. KG phosphate hemihydrate Benzstr.1 D-61352 Bad Homburg Germany Luxembourg GlaxoSmithKline Paracetamol/Codeine Panadol codéine 500mg/30mg tablet oral use Consumer Healthcare phosphate hemihydrate S.A. Site Apollo avenue Pascal 2-6 B- 1300 Wavre Belgium Luxembourg Mylan bvba/sprl Paracetamol/Codeine Paracod Mylan 500mg /30mg dispersible tablet oral use Rozendal Businesspark phosphate Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium Luxembourg bene-Arzneimittel Paracetamol/Codeine Talvosilen forte 500/30 500mg/30mg tablet oral use GmbH Herterichstraße phosphate hemihydrate 1-3 D-81479 München Germany Luxembourg bene-Arzneimittel Paracetamol/Codeine Talvosilen forte 1000/60 1000mg/60 mg suppository rectal use GmbH Herterichstraße phosphate hemihydrate 1-3 D-81479 München Germany Malta Wockhardt UK Ltd., Codeine phosphate Codeine Phosphate 30mg tablet oral use Ash Road North 30mg Tablets Wrexham, LL13 9 UF, United Kingdom

27

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Malta Seton Products Ltd., Paracetamol Syndol 450mg tablet oral use Tubiton House, Codeine Phosphate 10mg Medlock Street, Doxylamine succinate 5mg Oldham, OL1 3HS, Caffeine 30mg United Kingdom Malta Crookes Healthcare Ibuprofen Nurofen Plus 200.0mg tablet oral use Ltd 1 Thane Road Codeine phosphate 12.8mg West Nottingham NG2 3AA United Kingdom Malta GlaxoSmithKline Paracetamol Solpadeine Soluble 500mg effervescent oral use Consumer Healthcare Codeine Phosphate Tablets 8mg tablet (Ireland) Limited Hemihydrate Stonemasons Way Caffeine 30mg Rathfarnham Dublin 16 Ireland Malta SmithKline Beecham Paracetamol Solpadeine Plus 500mg capsule, hard oral use (SWG) Limited Codeine Phosphate Capsules 8mg 980 Great West Road Hemihydrate Brentford Caffeine 30mg Middlesex TW8 9GS United Kingdom Trading as Sterling Health or GlaxoSmithKline Consumer Healthcare or SmithKline Beecham International, Brentford, TW8 9GS United Kingdom

28

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Malta SmithKline Beecham Ibuprofen Solpadeine Migraine 200.0 mg film-coated tablet oral use (SWG) Limited Codeine phosphate Ibuprofen & Codeine 12.8 mg 980 Great West Road hemihydrate Tablets Brentford Middlesex TW8 9GS United Kingdom Trading as Sterling Health or GlaxoSmithKline Consumer Healthcare or SmithKline Beecham International, Brentford, TW8 9GS. Malta McNeil Products Ltd., Migraleve Pink Migraleve Migraleve Pink film-coated tablet oral use Foundation Park, Tablets: Paracetamol, Tablets: 520mg, Roxborough Way, codeine phosphate, 8mg, 6.25mg Maidenhead, Berkshire buclizine SL6 3UG hydrochloride Mi Migraleve Yellow United Kingdom graleve Yellow Tablets: Tablets: 520mg, Paracetamol, codeine 8mg phosphate

Malta McNeil Products Ltd., Paracetamol/codeine Migraleve Yellow 520mg/8mg film-coated tablet oral use Foundation Park, phosphate Roxborough Way, Maidenhead, Berkshire SL6 3UG United Kingdom Malta M&A Pharmachem Paracetamol/codeine Co-Codamol Tablets BP 500mg/8mg tablet oral use Limited, Allenby phosphate 8/500mg Laboratories, Wigan Road, Westhoughton Bolton BL5 2AL United Kingdom

29

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Norway Vitabalans Oy, Paracetamol/ Codein Paramax Comp 500 mg/30 mg tablet oral use Varastokatu 8, 13500 phosphate hemihydrate Hameenlinna, Finland. Norway ratiopharm Oy- Teva Paracetamol/ Codein Codaxol 500 mg/30 mg tablet oral use Group Menmber, phosphate hemihydrate Keilaranta 10 E, 02150 Espoo, Finland Norway Actavis Group hf. - Paracetamol/ Codein Pinex Forte 500 mg/30 mg effervescent oral use Reykjavikurvegur 76- phosphate hemihydrate tablet 78 - 220 Hafnarfjörður Iceland Norway Actavis Group hf. - Paracetamol/ Codein Pinex Forte 500 mg/30 mg tablet oral use Reykjavikurvegur 76- phosphate hemihydrate 78 - 220 Hafnarfjörður Iceland Norway Actavis Group hf. - Paracetamol/ Codein Pinex Forte 500 mg/30 mg suppository rectal use Reykjavikurvegur 76- phosphate hemihydrate 78 - 220 Hafnarfjörður Iceland Norway Weifa AS, Paracetamol/ Codein Paralgin Forte 400mg/30 mg suppository rectal use Hausmannsgate 6, phosphate P.O.Box 9113 sesquihydrate Grønland, NO-0133 Oslo, Norway Norway Weifa AS, Paracetamol/ Codein Paralgin Minor 200mg/15 mg suppository rectal use Hausmannsgate 6, phosphate P.O.Box 9113 sesquihydrate Grønland, NO-0133 Oslo, Norway

30

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Norway Weifa AS, Paracetamol/ Codein Paralgin Major 800mg/60 mg suppository rectal use Hausmannsgate 6, phosphate P.O.Box 9113 sesquihydrate Grønland, NO-0133 Oslo, Norway Norway Weifa AS, Paracetamol/ Codein Paralgin Forte 400mg/30 mg tablet oral use Hausmannsgate 6, phosphate P.O.Box 9113 sesquihydrate Grønland, NO-0133 Oslo, Norway Poland Bristol-Myers Squibb Paracetamolum + Efferalgan Codeine 500mg + 30mg effervescent oral use Polska Sp. z o.o. Codeini phosphas tablet Al. Armii Ludowej 26 00-609 Warszawa Poland Poland bene Arzneimittel Paracetamolum + Talvosilen Forte 500mg + 30mg capsule oral use GmbH Codeini phosphas Herterichstrasse 1 hemihydricus D-81479 Munchen Germany Poland bene Arzneimittel Paracetamolum + Talvosilen 500mg + 20mg tablet oral use GmbH Codeini phosphas Herterichstrasse 1 hemihydricus D-81479 Munchen Germany Poland Bristol-Myers Squibb Paracetamolum + Dafalgan codeine 500mg + 30mg film-coated tablet oral use Polska Sp. z o.o. Codeini phosphas Al. Armii Ludowej 26 00-609 Warszawa Poland

31

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Poland Zentiva, k.s. Paracetamolum + Ultracod 500mg + 30mg tablet oral use U kabelovny 130 Codeini phosphas Praha 10 hemihydricus 10237 Dolni Mecholupy Czech Republic Poland Vitabalans Oy Paracetamolum + Paramax-Cod 500mg + 30mg tablet oral use Varastokatu 8 Codeini phosphas FIN-13500 hemihydricus Hameenlinna Finland Poland Zakłady Acidum Ascodan 400mg + 8mg tablet oral use Farmaceutyczne acetylsalicylicum + POLPHARMA S.A. Codeini phosphas ul. Pelplińska 19 Starogard Gdański 83-200 Poland Poland Reckitt Benckiser Ibuprofenum + Codeini Nurofen Plus 200mg + 12,8mg film-coated tablet oral use (Poland) S.A. phosphas Okunin 1 Nowy Dwór Mazowiecki 05-100 Poland Poland OMEGA Pharma Poland Paracetamolum + Solpadeine 500mg + 8mg + capsule oral use Sp. z o.o. Codeini phosphas + 30mg Niepodleglosci 18 Coffeinum 02-653 Warsaw Poland

Poland OMEGA Pharma Poland Paracetamolum + Solpadeine 500mg + 30mg + effervescent oral use Sp. z o.o. Coffeinum + Codeini 8mg tablet Niepodleglosci 18 phosphas 02-653 Warsaw Poland

32

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Poland OMEGA Pharma Poland Paracetamolum + Solpadeine 500mg + 8mg + tablet oral use Sp. z o.o. Codeini phosphas + 30mg Niepodleglosci 18 Coffeinum 02-653 Warsaw Poland

Portugal Bayer Portugal, S.A. Acetylsalicylic acid + Dolviran 400mg + 7.5mg + tablet oral use Rua Quinta do Pinheiro Codeine phosphate 50mg 5 2794-003 hemihydrate + Caffeine Carnaxide Portugal Portugal Bayer Portugal, S.A. Acetylsalicylic acid + Dolviran 400mg + 7.5mg + suppository rectal use Rua Quinta do Pinheiro Codeine phosphate 50mg 5 2794-003 hemihydrate + Caffeine Carnaxide Portugal Portugal Johnson & Johnson, Paracetamol + Codeine Migraleve 500mg + 8mg + coated tablet oral use Lda. Estrada phosphate + Buclizine 6.25mg Consiglieri Pedroso, 69 hydrochloride A - Queluz de Baixo 2730-055 Barcarena Portugal Romania S.C. Fabiol S.A, B-dul codeinum CODEINA FABIOL 15 mg 15 mg tablet oral use Timişoara nr. 50, Bucureşti, 61333 Romania Romania S.C. LaborMed Pharma codeinum CODEINA FOSFAT LPH 15 mg tablet oral use S.A.,B-dul Theodor 15 mg Pallady nr. 44 B,sector 3, 032266 Bucureşti, Romania Romania S.C. SINTOFARM codeinum FOSFAT DE CODEINA 15 15 mg tablet oral use S.A.Str. Ziduri între Vii mg nr.22, Bucureşti, sector 3, 023324 Romania

33

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Romania S.C. Farmacom S.A. codeinum FARMACOD 15 mg tablet oral use Str. Zizinului Nr. 112, 2200 Braşov, 500407 Romania Romania S.C. MAGISTRA C & C codeinum CODEINA FOSFAT MCC 15 mg tablet oral use S.R.L.Bd-ul Aurel 15 mg Vlaicu nr. 82 A, Constanţa, Romania Romania S.C. Slavia Pharm codeinum CODEINA FOSFAT 15 mg tablet oral use S.R.L. Str. Ştirbei Vodă Nr. 53-55, Sector 1, Bucureşti, 10103 Romania Romania S.C. Bio EEL S.R.L.Str. codeinum CODEINA FOSFORICA 15 mg tablet oral use Bega Nr. 4, Târgu- Mureş, 540390 Romania Romania GEDEON RICHTER acid acetilsalicilic, FASCONAL 200mg+200mg+10 tablet oral use ROMÂNIA SA paracetamol , fosfat de mg+25mg Str. Cuza Vodă nr. 99- codeină hemihidrat , 105, Târgu-Mureş, cafeină anhidră Romania

Romania S.C. Bio EEL S.R.L.Str. acid acetilsalicilic, ASPACO 300mg + 250mg + tablet oral use Bega Nr. 4, Târgu- paracetamol , fosfat de 12mg Mureş, 540390 codeină hemihidrat Romania Romania HIPOCRATE 2000 paracetamol, fosfat de SOLPADEINE 500 mg/8 500 mg+8 mg+30 effervescent oral use S.R.L. Str. Prahova, codeină hemihidrat, mg/30 mg comprimate mg tablet Nr. 6A, Sector 1, cafeină anhidră efervescente Bucureşti 012423, România

34

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Romania HIPOCRATE 2000 paracetamol, fosfat de SOLPADEINE 500 mg+8 mg+30 tablet oral use S.R.L. Str. Prahova, codeină hemihidrat, COMPRIMATE mg Nr. 6A, Sector 1, cafeină anhidră Bucureşti 012423, România

Romania S.C. TERAPIA S.A paracetamol, cafeină CODAMIN P 400mg+ tablet oral use Str. Fabricii Nr.124, anhidră, fosfat de 23mg+15mg Cluj-Napoca, Judeţul codeină hemihidrat Cluj, 400632 Romania Romania ALKALOID - INT d.o.o paracetamol, CAFFETIN 250mg+ tablet oral use Šlandrova ulica 4, propifenazonă , cafeină 210mg+50mg+10m 1231 Ljubljana - , fosfat de codeină g Črnuče, Slovenia sesquihidrat Romania Zentiva, k.s.U paracetamolum+ ULTRACOD 500 mg/30 500mg/30mg tablet oral use kabelovny 130, Dolní codeinum mg Měcholupy 102 37, Praga 10, Czech Republic Romania RECKITT BENCKISER ibuprofen, fosfat de NUROFEN PLUS 200mg +12,8 mg film-coated tablet oral use HEALTHCARE codeină hemihidrat INTERNATIONAL LIMITED 103-105 Bath Road, Slough, Berkshire SL1 3UH, United Kingdom Slovak Zentiva a.s. acetylsalicylic acid + Alnagon Neo 380 mg + 20 mg tablet oral use Republic Nitrianska 100, codeine + caffeine (Zentiva) +80 mg Hlohovec 920 27 Slovak Republic Slovak Zentiva a.s. codeine Codein-SLOVAKOFARMA 15 mg tablet oral use Republic Nitrianska 100, 15 mg Hlohovec 920 27 Slovak Republic

35

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Slovak Zentiva a.s. codeine Codein-SLOVAKOFARMA 30 mg tablet oral use Republic Nitrianska 100, 30 mg Hlohovec 920 27 Slovak Republic Slovak Zentiva k.s. codeine + paracetamol Korylan 21,17 mg +325 mg tablet oral use Republic U kabelovny 130, Praha 102 37 Czech Republic Slovak GlaxoSmithKline codeine + paracetamol Panadol Ultra, Panadol 8 mg+500 mg +30 capsule, tablet, oral use Republic Consumer Healthcare, + caffeine Ultra Rapide mg effervescent GlaxoSmithKline tablet Export Ltd. 980 Great West Road, TW8 9GS Brentford United Kingdom Slovak Vitabalans Oy codeine + paracetamol Paramax-Cod 30 mg +500 mg tablet oral use Republic Varastokatu 8, (Vitabalans) Hämeenlinna FI-13500 Finland Slovak Zentiva k.s. codeine + paracetamol Spasmopan 19,2 mg+500 suppository rectal use Republic U kabelovny 130, + fenpiverine + mg+0,1 mg +10 mg Praha 102 37 pitofenon Czech Republic Slovenia Alkaloid-Int. d.o.o. codeine, paracetamol, Caffetin tablete 10 mg, 250 mg, 210 tablet oral use Šlandrova 4, propyphenazone, mg, 50 mg 1231 Ljubljana- caffeine Črnuče Slovenia Slovenia Pliva Ljubljana d.o.o., codein e, paracetamol, Plivadon tablete 10 mg, 210 mg, 250 tablet oral use Pot k sejmišču 35, propyphenazone, mg, 25 mg 1000 Ljubljana, caffeine Slovenia

36

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Spain TEVA PHARMA, S.L.U. Codeine phosphate CODEISAN 28,7 mg tablet oral use C/ Anabel Segura, 11 hemihydrate COMPRIMIDOS Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain Spain TEVA PHARMA, S.L.U. Codeine phosphate CODEISAN JARABE 6,33 mg/ 5 ml oral solution oral use C/ Anabel Segura, 11 hemihydrate Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain Spain LABORATORIOS ERN, Acetylsalicylic acid, DOLMEN 500 mg, 10 mg and effervescent oral use S.A. Pedro IV, 499 codeine phosphate 250 mg tablet 08022 Barcelona hemihydrate and Spain ascorbic acid

Spain LABORATORIOS Codeine phosphate, DOLODENS GRAGEAS 10 mg, 15 mg and coated tablet oral use ASOCIADOS NUPEL, hidroxicine 100 mg S.L. dichlorhydrate and Rua Carpeinteiros, 25 propifenazone Polígono Industrial Ceao 27003 Lugo Spain Spain TEOFARMA, S.R.L. Codeine phosphate, CALMOPLEX 200 mg/ 10 10 mg, 10 mg and coated tablet oral use Vía F. Lli Cervi, 8 hidroxicine mg/ 10 mg comprimidos 200 mg 27010 Valle Salimbene dichlorhydrate and recubiertos (Pavia) propifenazone Italy

37

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Spain FAES FARMA, S.A. Paracetamol, codeine ANALGILASA 500 mg, 10 mg and film-coated tablet oral use Máximo Aguirre, 14 phosphate and caffeine COMPRIMIDOS 30 mg 48940 Lamiaco-Lejona RECUBIERTOS (Vizcaya)

Spain FAES FARMA, S.A. Paracetamol and ANALGIPLUS 500 mg/ 500 mg and 30 mg film-coated tablet oral use Máximo Aguirre, 14 codeine phosphate 30 mg comprimidos 48940 Lamiaco-Lejona hemihydrate recubiertos con película (Vizcaya) Spain Spain KERN PHARMA, S.L. Paracetamol and DOLOMEDIL 500 mg and 10 mg tablet oral use Venus, 72 codeine phosphate COMPRIMIDOS Polígono Industrial Colon II 08228 Tarrasa (Barcelona) Spain Spain KERN PHARMA, S.L. Acetylsalicylic acid, DOLVIRÁN 400 mg, 9.6 mg and tablet oral use Venus, 72 codeine phosphate COMPRIMIDOS 50 mg Polígono Industrial hemihydrate and Colon II caffeine 08228 Tarrasa (Barcelona) Spain Spain KERN PHARMA, S.L. Acetylsalicylic acid, DOLVIRÁN 400 mg, 9.6 mg and suppository rectal use Venus, 72 Cod eine phosphate SUPOSITORIOS 50 mg Polígono Industrial hemihydrate and Colon II caffeine 08228 Tarrasa (Barcelona) Spain Spain ALMIRALL, S.A. Paracetamol and ALGIDOL 600 mg/10 650 mg, 10 mg and granules for oral oral use Ronda General Mitre, codeine phosphate mg/ 500 mg granulado 500 mg solution 151 hemihydrate and para solución oral 08022 Barcelona ascorbic acid Spain

38

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Spain FERRER Paracetamol, codeine DOLOCATIL CODEÍNA 325 mg and 15 mg tablet oral use INTERNACIONAL, S.A. phosphate hemihydrate 325 mg/ 15 mg Gran Vía Carlos III, 94 comprimidos 08028 Barcelona Spain Spain FERRER Paracetamol and DOLOCATIL CODEÍNA 650 mg and 30 mg tablet oral use INTERNACIONAL, S.A. c odeine phosphate 650 mg/ 30 mg Gran Vía Carlos III, 94 hemihydrate comprimidos 08028 Barcelona Spain Spain FERRER Paracetamol and DOLOCATIL CODEÍNA 500 mg and 15 mg tablet oral use INTERNACIONAL, S.A. codeine phosphate 500 mg/ 15 mg Gran Vía Carlos III, 94 comprimidos 08028 Barcelona Spain Spain BRISTOL MYERS Paracetamol and COD-EFFERALGAN 500 500 mg and 30 mg effervescent oral use SQUIBB, S.A. codeine phosphate mg/ 30 mg comprimdos tablet Quintanavides, 15 hemihydrate efervescentes 28050 Madrid Spain Spain LABORATORIOS ERN, Paracetamol and PARACETAMOL CODEÍNA 120 mg and 12 mg / oral solution oral use S.A. Pedro IV, 499 codeine phosphate LEVEL SOLUCIÓN ORAL 5 ml 08022 Barcelona Spain Spain LABORATORIOS ERN, Paracetamol and TALGO CODEÍNA 300 mg and 30 mg tablet oral use S.A. Pedro IV, 499 codeine phosphate COMPRIMIDOS 08022 Barcelona Spain Spain ITALFARMACO, S.A. Paracetamol and COXUMADOL 500 mg and 30 mg effervescent oral use San Rafael, 3 codeine phosphate granules 28108 Alcobendas hemihydrate (Madrid) Spain

39

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Spain FARMASIERRA Ibuprofen and codeine ASTEFOR 400 mg/30 mg 400 mg and 30 mg granules for oral oral use LABORATORIOS, S.L. phosphate hemihydrate granulado para suspension Ctra. Irún, Km. 26.200 suspensión oral 28700 San Sebastián de los Reyes (Madrid) Spain Spain FARMASIERRA Ibuprofen and codeine ASTEFOR 400 mg/30 mg 400 mg and 30 mg film-coated tablet oral use LABORATORIOS, S.L. phosphate hemihydrate comprimidos recubiertos Ctra. Irún, Km. 26.200 con película 28700 San Sebastián de los Reyes (Madrid) Spain Spain ABBOTT Ibuprofen and codeine NEOBRUFEN CON 400 mg and 30 mg film-coated tablet oral use LABORATORIES, S.A. phosphate hemihydrate CODEÍNA 400 mg/ 30 Avda. de Burgos, 91 mg comprimidos 28050 Madrid recubiertos con película Spain Spain CANTABRIA PHARMA, Ibuprofen and codeine NIDOL 400 mg/ 30 mg 400 mg and 30 mg film-coated tablet oral use S.L. C/ Ribera del phosphate hemihydrate comprimidos recubiertos Loira, 46 con película Edificio 2 28042 Madrid Spain Spain FARMALIDER, S.A. Ibuprofen and codeine HYTRIN 200 mg/ ml + 200 mg and 10 mg oral solution oral use Aragoneses, 15 phosphate hemihydrate 10 mg/ ml solución oral /1 ml 28108 Madrid Spain Spain FARMALIDER, S.A. Ibuprofen and codeine IBUCOD 200 mg/ ml + 200 mg and 10 mg oral solution oral use Aragoneses, 15 phosphate hemihydrate 10 mg/ ml solución oral /1 ml 28108 Madrid Spain

40

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Spain KERN PHARMA, S.L. Paracetamol and PARACETAMOL/CODEÍN 500 mg and 30 mg tablet oral use Venus, 72 codeine phosphate A KERN PHARMA 500 Polígono Industrial hemihydrate mg/ 30 mg comprimidos Colon II EFG 08228 Tarrasa (Barcelona) Spain Spain KERN PHARMA, S.L. Paracetamol and PARACETAMOL/CODEÍN 500 mg and 30 mg tablet oral use Venus, 72 codeine phosphate A PHARMAKERN 500 Polígono Industrial hemihydrate mg/ 30 mg comprimidos Colon II EFG 08228 Tarrasa (Barcelona) Spain Spain NOVARTIS CONSUMER Paracetamol and TERMALDINA CODEINA 650 mg and 28,09 suppository rectal use HEALTH, S.A. anhidrous codeine 650 mg/30 mg mg Gran Vía de les Corts phosphate supositorios Catalanes, 764 08013 Barcelona Spain Spain NOVARTIS CONSUMER Paracetamol and TERMALDINA CODEINA 300 mg and 14,05 capsule, hard oral use HEALTH, S.A. anhidrous codeine 300 mg/15 mg cápsulas mg Gran Vía de les Corts phosphate Catalanes, 764 08013 Barcelona Spain Spain LABORATORIOS Paracetamol and FLUDETEN comprimidos 500 mg and 30 mg effervescent oral use ALTER, S.A. codeine phospate efervescentes tablet Mateo Inurria, 30 28036 Madrid Spain

41

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Spain LABORATORIOS Paracetamol, Buclizine MIGRALEVE 500 mg, 6,25 mg, 8 tablet oral use LLORENS, S.A. chlorhidrate, codeine comprimidos mg and 10 mg Ciudad de Balaguer, 7- phosphate and 11 08022 docusate sodium Barcelona Spain Sweden BioPhausia AB Kodein/Paracetamol Citodon minor 350mg/15mg suppository rectal use Blasieholmsgatan 2 111 48 Stockholm Sweden

Sweden BioPhausia AB Kodein/Paracetamol Citodon forte 1000mg/60 mg suppository rectal use Blasieholmsgatan 2 111 48 Stockholm Sweden

Sweden BioPhausia AB Kodein/Paracetamol Citodon 500 mg/30 mg tablet oral use Blasieholmsgatan 2 111 48 Stockholm Sweden

Sweden BioPhausia AB Kodein/Paracetamol Citodon 500 mg/30 mg suppository rectal use Blasieholmsgatan 2 111 48 Stockholm Sweden

Sweden BioPhausia AB Kodein/Paracetamol Citodon 500 mg/30 mg effervescent oral use Blasieholmsgatan 2 tablet 111 48 Stockholm Sweden

Sweden Meda AB codeine phosphate Treo® comp 500mg/50mg/30mg effervescent oral use Box 906 hemihydrate/caffeine/ tablet 170 09 Solna acetylsalicylic acid Sweden

42

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Sweden Meda AB codeine phosphate Codalvonil 500 mg/30 mg effervescent oral use Box 906 hemihydrate/ tablet 170 09 Solna paracetamol Sweden Sweden sanofi-aventis AB codeine phosphate Panocod® 500 mg/30 mg tablet oral use Box: 14142 hemihydrate/ 167 14 Bromma paracetamol Sweden

Sweden sanofi-aventis AB codeine phosphate Panocod® 500 mg/30 mg effervescent oral use Box: 14142 hemihydrate/ tablet 167 14 Bromma paracetamol Sweden

Sweden Recip AB codeine phosphate Kodein Recip 25mg tablet oral use Box: 906 hemihydrate 170 09 Solna Sweden

Sweden Mundipharma AB, ibuprofen/codeine Ardinex® 200 mg/30 mg tablet oral use Mölndalsvägen 30 phosphate hemihydrate 412 63 Göteborg Sweden

Sweden Evolan Pharma AB codeine phosphate Paracetamol/Kodein 500 mg/30 mg effervescent oral use Box: 120 hemihydrate/ Evolan tablet 182 12 Danderyd paracetamol Sweden

43

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) Sweden Evolan Pharma AB codeine phosphate Paracetamol/Kodein 500 mg/30 mg tablet oral use Box: 120 hemihydrate/ Evolan 182 12 Danderyd paracetamol Sweden

Sweden Meda AB codeine hydrochloride Spasmofen 0,4 mg, solution for parenteral use Box 906 dihydrate, 20 mg, injection 170 09 Solna papaverine 6,6 mg, Sweden hydrochloride, 0,15 mg, morphine 3 mg hydrochloride, (in each ml) hyoscine methonitrate, noscapine hydrochloride Sweden Meda AB codeine hydrochloride Spasmofen 0,8mg, suppository rectal use Box 906 dihydrate, 40 mg, 170 09 Solna papaverine 13 mg, Sweden hydrochloride, 0,5 mg, morphine 6 mg hydrochloride, hyoscine methonitrate, noscapine hydrochloride The ratiopharm Nederland Paracetamol Paracetamol/Codeinefosf 500 mg tablet oral use Netherlands B.V. Codeine aat ratiopharm 500 20 mg Florapark 4 mg/20 mg, tabletten 2012 HK Haarlem The Netherlands The Pharmachemie B.V. Codeine Codeine HCl 10 PCH, 10 mg tablet oral use Netherlands Swensweg 5 tabletten 10 mg 2031 GA Haarlem The Netherlands The Pharmachemie B.V. Codeine Codeine HCl 20 PCH, 20 mg tablet oral use Netherlands Swensweg 5 tabletten 20 mg 2031 GA Haarlem The Netherlands

44

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) The ratiopharm Nederland Codeine Codeinefosfaat 10 mg tablet oral use Netherlands B.V. ratiopharm 10 mg, Florapark 4 tabletten 2012 HK Haarlem The Netherlands The ratiopharm Nederland Codeine Codeinefosfaat 20 mg tablet oral use Netherlands B.V. ratiopharm 20 mg, Florapark 4 tabletten 2012 HK Haarlem The Netherlands The Pharmachemie B.V. Codeine Codeinefostaat 10 PCH, 10 mg tablet oral use Netherlands Swensweg 5 tabletten 10 mg 2031 GA Haarlem The Netherlands The Pharmachemie B.V. Codeine Codeinefostaat 15 PCH, 15 mg tablet oral use Netherlands Swensweg 5 tabletten 15 mg 2031 GA Haarlem The Netherlands The Pharmachemie B.V. Codeine Codeinefostaat 20 PCH, 20 mg tablet oral use Netherlands Swensweg 5 tabletten 20 mg 2031 GA Haarlem The Netherlands The Pharmachemie B.V. Paracetamol Paracetamol/Codeinefosf 500 mg tablet oral use Netherlands Swensweg 5 Codeine aat 500/20 PCH, 20 mg 2031 GA Haarlem tabletten 500 mg/20 mg The Netherlands The Pharmachemie B.V. Paracetamol Paracetamol/Codeinefosf 500 mg tablet oral use Netherlands Swensweg 5 Codeine aat 500/50 PCH, 50 mg 2031 GA Haarlem tabletten 500 mg/50 mg The Netherlands The Apotex Europe B.V. Paracetamol Paracetamol/codeinefosf 500 mg tablet oral use Netherlands Darwinweg 20 Codeine aat Apotex 500/10 mg, 10 mg 2333 CR Leiden tabletten The Netherlands

45

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) The Apotex Europe B.V. Paracetamol Paracetamol/codeinefosf 500 mg tablet oral use Netherlands Darwinweg 20 Codeine aat Apotex 500/20 mg, 20 mg 2333 CR Leiden tabletten The Netherlands The Pharmachemie B.V. Paracetamol Paracetamol/Codeinefosf 500 mg tablet oral use Netherlands Swensweg 5 Codeine aat 500/10 PCH, 10 mg 2031 GA Haarlem tabletten 500 mg/10 mg The Netherlands The ratiopharm Nederland Paracetamol Paracetamol/Codeinefosf 500 mg tablet oral use Netherlands B.V. Codeine aat ratiopharm 500 10 mg Florapark 4 mg/10 mg, tabletten 2012 HK Haarlem The Netherlands The Pharmachemie B.V. Acetylsalicylacid A.C. Cod., suppositoria 400 mg suppository rectal use Netherlands Swensweg 5 Codeine 9.6 mg 2031 GA Haarlem Caffeine 50 mg The Netherlands United Bayer plc, Bayer paracetamol + codeine Co-Codamol Disp 500mg + 8mg tablet for oral oral use Kingdom House, Strawberry solution Hill, Newbury, Berkshire RG14 1JA, United Kingdom United Bayer plc, Bayer paracetamol + codeine Paracodol Capsules 500mg + 8mg capsule oral use Kingdom House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom United Bayer plc, Bayer paracetamol + codeine Paracodol Tablets 500mg + 8mg tablet for oral Oral use Kingdom House, Strawberry solution Hill, Newbury, Berkshire RG14 1JA, United Kingdom

46

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United Bayer plc, Bayer paracetamol + codeine Bayer Co-Codamol 500mg + 8mg capsule, hard Oral use Kingdom House, Strawberry 8/500mg capsules Hill, Newbury, Berkshire RG14 1JA, United Kingdom United The Boots Company aspirin + codeine Boots Aspirin and 400mg + 8mg tablet Oral use Kingdom Plc, 1 Thane Road phosphate Codeine Tablets West, NG2 3AA, Nottingham, United Kingdom United The Boots Company paracetamol + codeine Paracetamol and 500mg + 8mg tablet Oral use Kingdom Plc, 1 Thane Road Codeine Caplets West, NG2 3AA, Nottingham, United Kingdom United The Boots Company paracetamol + codeine Boots Pain Relief Plus 500mg + 8mg capsule Oral use Kingdom Plc, 1 Thane Road Capsules West, NG2 3AA, Nottingham, United Kingdom United The Boots Company paracetamol + codeine Boots Paracetamol and 500mg + 8mg + capsule, hard Oral use Kingdom Plc, 1 Thane Road + caffeine Codeine Extra Capsules 30mg West, NG2 3AA, Nottingham, United Kingdom United The Boots Company ibuprofen + codeine Boots Ibuprofen and 200mg +12.8mg film-coated tablet Oral use Kingdom Plc, 1 Thane Road Codeine Tablets West, NG2 3AA, Nottingham, United Kingdom United UCB Pharma Limited, paracetamol + codeine Tylex Tablets 500mg + 8mg coated tablet oral use Kingdom 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom

47

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United UCB Pharma Limited, paracetamol + codeine Medocodene 30/500 500mg + 30mg capsule oral use Kingdom 208 Bath Road, Capsules Slough, Berkshire SL1 3WE, United Kingdom United UCB Pharma Limited, paracetamol + codeine Tylex 30/500 500mg + 30mg effervescent oral use Kingdom 208 Bath Road, Effervescent tablet Slough, Berkshire SL1 3WE, United Kingdom United Reckitt Benkiser paracetamol + codeine Codis 500 Tablets 500mg + 8mg tablet for oral oral use Kingdom Healthcare (UK) solution Limited, Wellcroft House, Wellcroft Road, Slough, Berkshire SL1 4AQ, United Kingdom United Reckitt Benkiser ibuprofen + codeine Nurofen Plus 200mg +12.8mg coated tablet oral use Kingdom Healthcare (UK) Limited, Wellcroft House, Wellcroft Road, Slough, Berkshire SL1 4AQ, United Kingdom United Omega Pharma paracetamol + codeine Solpadeine Plus 500mg + 8mg + capsule oral use Kingdom Limited + caffeine Capsules 30mg 32 Vauxhall Bridge Road London SW1V 2SA United Kingdom

48

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United Omega Pharma paracetamol + codeine Solpadeine Max 500mg + 12.8mg tablet oral use Kingdom Limited 32 Vauxhall Bridge Road London SW1V 2SA United Kingdom United Omega Pharma paracetamol + codeine Solpadeine Max Soluble 500mg + 12.8mg + effervescent oral use Kingdom Limited + caffeine Tablets 30mg tablet 32 Vauxhall Bridge Road London SW1V 2SA United Kingdom United Omega Pharma paracetamol + codeine Solpadeine Plus Soluble 500mg +8mg + tablet for oral oral use Kingdom Limited + caffeine Tablets 30mg solution 32 Vauxhall Bridge Road London SW1V 2SA United Kingdom United Omega Pharma paracetamol + codeine Solpadeine Plus Tablets 500mg +8mg + tablet oral use Kingdom Limited + caffeine 30mg 32 Vauxhall Bridge Road London SW1V 2SA United Kingdom United Omega Pharma ibuprofen +codeine Solpaflex Tablets 200mg +12.8mg film-coated tablet oral use Kingdom Limited 32 Vauxhall Bridge Road London SW1V 2SA United Kingdom

49

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United Omega Pharma paracetamol + codeine Solpadeine Max Tablets 500mg + 12.8mg film-coated tablet oral use Kingdom Limited 32 Vauxhall Bridge Road London SW1V 2SA United Kingdom United Actavis UK Limited aspirin + codeine Dispersible Co-Codaprin 400mg + 8mg tablet for oral oral use Kingdom Whiddon Valley, phosphate Tablets BP solution Barnstaple, Devon, EX32 8NS United Kingdom United Actavis UK Limited paracetamol + codeine Cox Co-Codamol Tablets 500mg + 8mg tablet oral use Kingdom Whiddon Valley, Barnstaple, Devon, EX32 8NS United Kingdom United Actavis UK Limited codeine phosphate Cox Codeine Phosphate 15mg tablet oral use Kingdom Whiddon Valley, Tablets BP 15mg Barnstaple, Devon, EX32 8NS United Kingdom United Actavis UK Limited codeine phosphate Codeine Phosphate 30mg tablet oral use Kingdom Whiddon Valley, Tablets BP 30mg Barnstaple, Devon, EX32 8NS United Kingdom United Actavis UK Limited codeine phosphate Codeine Phosphate 60mg tablet oral use Kingdom Whiddon Valley, Tablets BP 60mg Barnstaple, Devon, EX32 8NS United Kingdom

50

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United Teva UK Limited, paracetamol + codeine Teva UK Co-Codamol 500mg + 8mg tablet oral use Kingdom Brampton Road, Tablets 8/500 Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom United Teva UK Limited, codeine phosphate Codeine Phosphate 15mg tablet oral use Kingdom Brampton Road, Tablets BP 15mg Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom United Teva UK Limited, codeine phosphate Codeine Phosphate 30mg tablet oral use Kingdom Brampton Road, Tablets BP 30mg Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom United Teva UK Limited, codeine phosphate Codeine Phosphate 60mg tablet oral use Kingdom Brampton Road, Tablets BP 60mg Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom United Macarthy's codeine phosphate Macarthy's Codeine 6.1% w/v Solution for intramuscular Kingdom Laboratories Limited, Phosphate Injection BP Injection Bampton Road, Harold 60mg/ml Hill, Romford, Esses RM3 8UG, United Kingdom United Omega Pharma paracetamol + codeine Veganin 500mg + 8mg + film-coated tablet oral use Kingdom Limited + caffeine 30mg 32 Vauxhall Bridge Road London SW1V 2SA United Kingdom

51

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United M & A Pharmachem paracetamol + codeine Pharmachem Co- 500mg + 8mg tablet oral use Kingdom Limited, Allenby Codamol Tablets 8/500 Laboratories, Wigan Road, Westhoughton, Bolton, Lancashire BL5 2AL, United Kingdom United M & A Pharmachem paracetamol + codeine M&A Pharmachem Co- 500mg + 30mg tablet oral use Kingdom Limited, Allenby Codamol Tablets 30/500 Laboratories, Wigan Road, Westhoughton, Bolton, Lancashire BL5 2AL, United Kingdom United M & A Pharmachem paracetamol + codeine M&A Pharmachem Co- 500mg + 60mg tablet oral use Kingdom Limited, Allenby Codamol Tablets 60/500 Laboratories, Wigan Road, Westhoughton, Bolton, Lancashire BL5 2AL, United Kingdom United Sandoz Limted, codeine phosphate Codeine Phosphate 15mg tablet oral use Kingdom Frimley Business Park, Tablets BP 15mg Frimley, Camberley, Surrey GU16 7SR, United Kingdom United Sandoz Limted, codeine phosphate Codeine Phosphate 30mg tablet oral use Kingdom Frimley Business Park, Tablets BP 30mg Frimley, Camberley, Surrey GU16 7SR, United Kingdom United Sandoz Limted, codeine phosphate Codeine Phosphate 60mg tablet oral use Kingdom Frimley Business Park, Tablets BP 60mg Frimley, Camberley, Surrey GU16 7SR, United Kingdom

52

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United Sandoz Limted, paracetamol + Propain Plus Tablets 450mg + 5mg + tablet oral use Kingdom Frimley Business Park, doxylamine succinate + 30mg + 10 mg Frimley, Camberley, caffeine + codeine Surrey GU16 7SR, United Kingdom United Sandoz Limted, paracetamol + Propain tablets 400mg + 5mg + tablet oral use Kingdom Frimley Business Park, diphenhydramine 50mg + 10mg Frimley, Camberley, hydrochloride + Surrey GU16 7SR, caffeine + codeine United Kingdom United Sandoz Limted, paracetamol + codeine Sandoz Co-Codamol 500mg + 30mg tablet oral use Kingdom Frimley Business Park, Tablets 30/500mg Frimley, Camberley, Surrey GU16 7SR, United Kingdom United Aventis Pharma Codeine phosphate + Aventis Pharma Co- 30mg + 500 mg capsule, hard oral use Kingdom Limited, One Onslow paracetamol codamol Capsules Street, Guilford, 30mg/500mg Surrey GU1 4SY United Kingdom United Aventis Pharma Codeine phosphate + Solpadol Tablets 30mg + 500 mg effervescent Oral use Kingdom Limited, One Onslow paracetamol tablet Street, Guilford, Surrey GU1 4SY United Kingdom United Aventis Pharma Codeine phosphate + Solpadol Tablets 30mg + 500 mg tablet Oral use Kingdom Limited, One Onslow paracetamol Street, Guilford, Surrey GU1 4SY United Kingdom United Waymade Plc, Codeine phosphate Waymade codeine 15mg tablet Oral use Kingdom Sovereign House, phosphate tablets 15mg Miles Gray Road, Basildon, Essex SS14 3FR United Kingdom

53

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United Waymade Plc, Codeine phosphate Codeine phosphate 30mg tablet Oral use Kingdom Sovereign House, 30mg tablets Miles Gray Road, Basildon, Essex SS14 3FR United Kingdom United Waymade Plc, Codeine phosphate Codeine phosphate 60mg tablet Oral use Kingdom Sovereign House, 60mg tablets Miles Gray Road, Basildon, Essex SS14 3FR United Kingdom United Ranbaxy Ireland Codeine phosphate Codeine phosphate 15mg tablet Oral use Kingdom Limited, Spafield, Cork tablets BP 15mg Road, Cashel, Co. Tipperary, Ireland United Ranbaxy Ireland Codeine phosphate Codeine phosphate 30mg tablet Oral use Kingdom Limited, Spafield, Cork tablets BP 30mg Road, Cashel, Co. Tipperary, Ireland United Ranbaxy Ireland Codeine phosphate Codeine phosphate 60mg tablet Oral use Kingdom Limited, Spafield, Cork Tablets 60mg BP Road, Cashel, Co. Tipperary, Ireland United Aspar Pharmaceuticals Codeine phosphate + Aspar Pharms Co- 8mg + 500mg tablet Oral use Kingdom Limited, 29-30 Capitol paracetamol codamol Tablets Way, Colindale, 8mg/500mg London NW9 0EQ United Kingdom United Aspar Pharmaceuticals Codeine phosphate + Aspar Pharms Co- 8mg + 500mg tablet Oral use Kingdom Limited, 29-30 Capitol paracetamol codamol Tablets BP Way, Colindale, 8/500mg London NW9 0EQ United Kingdom

54

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United Tillomed Laboratories Codeine phosphate + Tillomed Labs Co- 8mg + 500mg tablet Oral use Kingdom Limited, 3 Howard paracetamol codamol Tablets Road, Eaton Socon, St 8mg/500mg Neots, Cambridgeshire PE19 8ET United Kingdom United Wrafton Laboratories Codeine phosphate Teva Dual Action Pain 8mg + 30mg + 500 capsule Oral use Kingdom Limited, Exeter Road, hemihydrate + caffeine Relief Capsules mg Wrafton, Braunton, + paracetamol Devon EX33 2DL United Kingdom United Wrafton Laboratories Codeine phosphate Wrafton Labs Co- 8mg + 30mg + 500 tablet Oral use Kingdom Limited, Exeter Road, hemihydrate + caffeine codamol Plus Caffeine mg Wrafton, Braunton, + paracetamol Tablets Devon EX33 2DL United Kingdom United Mercury Codeine phosphate + Mercury Pharms Co- 30mg + 500 mg capsule Oral use Kingdom Pharmaceuticals paracetamol codamol Capsules Limited, No. 1 30mg/500mg Croydon, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT United Kingdom United Mercury Codeine phosphate + Mercury Pharms Co- 30mg + 500 mg tablet Oral use Kingdom Pharmaceuticals paracetamol codamol Tablets Limited, No. 1 30mg/500mg Croydon, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT United Kingdom

55

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United Mercury Codeine phosphate + Mercury Pharms Co- 15mg + 500mg Coated tablet Oral use Kingdom Pharmaceuticals paracetamol codamol Tablets Limited, No. 1 15mg/500mg Croydon, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT United Kingdom United Mercury Codeine phosphate Codipar effervescent 15mg + 500mg effervescent Oral use Kingdom Pharmaceuticals hemihydrate + tablets 15mg/500mg tablet Limited, No. 1 paracetamol Croydon, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT United Kingdom United Mercury Codeine phosphate Mercury Pharms Co- 30mg + 500 mg effervescent Oral use Kingdom Pharmaceuticals hemihydrate + codamola effervescent tablet Limited, No. 1 paracetamol tablets 30mg/500mg Croydon, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT United Kingdom United Mercury Codeine phosphate + Codipar Capsules 15mg + 500mg capsule, hard Oral use Kingdom Pharmaceuticals paracetamol 15mg/500mg Limited, No. 1 Croydon, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT United Kingdom

56

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United South Devon Codeine phosphate Codeine phsophate 60mg/ml Solution for Intramuscular Kingdom Healthcare NHS injection 60mg in 1ml injection Foundation Trust, Torbay PMU, Long Road, Paignton, Devon TQ4 7TW United Kingdom United McNeil Products Codeine phosphate + Warner-Lambert CH 8mg + 520mg + Coated tablet Oral use Kingdom Limited, Foundation paracetamol + buclizine Migraleve Pink Tablets 6.25mg Park, Roxborough hydrochloride Way, Maidenhead, Berkshire SL6 3UG United Kingdom United McNeil Products Codeine phosphate + Warner-Lambert CH 8mg + 520mg Coated tablet Oral use Kingdom Limited, Foundation paracetamol Migraleve Yellow Tablets Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG United Kingdom United McNeil Products Codeine phosphate + Warner-Lambert CH 8mg + 520mg + Coated tablet Oral use Kingdom Limited, Foundation paracetamol + buclizine Migraleve Tablets 6.25mg Park, Roxborough hydrochloride Way, Maidenhead, Berkshire SL6 3UG United Kingdom United Manx Pharma Limited, Codeine phosphate Manx Pharma Co- 30mg + 500 mg effervescent Oral use Kingdom Taylor Group House, hemihydrate + codamol 30 mg/500 mg tablet Wedgnock Lane, paracetamol effervescent tablets Warwick CV34 5YA United Kingdom

57

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United Ayrton Saunders Codeine phosphate + Soluble Cupanol-Co 8mg + 500mg effervescent Oral use Kingdom Limited, 9 Arkwright paracetamol Lemon Flavour tablet Road, Astmoor Industrial Estate, Runcorn, Cheshire WA7 1NU United Kingdom United Ayrton Saunders Codeine phosphate + Co-codaprin Tablets 8mg + 400mg tablet Oral use Kingdom Limited, 9 Arkwright aspirin Road, Astmoor Industrial Estate, Runcorn, Cheshire WA7 1NU United Kingdom United Winthrop Codeine phosphate Winthrop Pharms UK Co- 30mg + 500mg tablet Oral use Kingdom Pharmaceuticals UK hemihydrate + codamol 30mg/500mg Limited, One Onslow paracetamol Street, Guildford, Surrey GU1 4YS United Kingdom United Winthrop Codeine phosphate Sterwin Meds Co- 30mg + 500mg effervescent oral use Kingdom Pharmaceuticals UK hemihydrate + codamol 30/500 tablet Limited, One Onslow paracetamol effervescent tablets Street, Guildford, 30mg/500mg Surrey GU1 4YS United Kingdom United Winthrop Codeine phosphate + Sterwin Meds Co- 8mg + 500mg tablet oral use Kingdom Pharmaceuticals UK paracetamol codamol 8/500 tablets Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom

58

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United Winthrop Codeine phosphate + Sterwin Meds Co- 8mg + 500mg Tablet for oral oral use Kingdom Pharmaceuticals UK paracetamol codamol 8/500 solution Limited, One Onslow effervescent tablets Street, Guildford, Surrey GU1 4YS United Kingdom United Winthrop Codeine phosphate + Sterwin Meds Co- 8mg + 500mg + effervescent oral use Kingdom Pharmaceuticals UK paracetamol + caffeine codamol and caffeine 30mg tablet Limited, One Onslow soluble tablets Street, Guildford, Surrey GU1 4YS United Kingdom United Winthrop Codeine phosphate Co-codamol tablets 15mg + 500mg tablet oral use Kingdom Pharmaceuticals UK hemihydrate + 15/500mg Limited, One Onslow paracetamol Street, Guildford, Surrey GU1 4YS United Kingdom United Winthrop Codeine phosphate Winthrop Pharms Co- 8mg + 500mg tablet oral use Kingdom Pharmaceuticals UK hemihydrate + codamol 8/500 tablets Limited, One Onslow paracetamol Street, Guildford, Surrey GU1 4YS United Kingdom United Winthrop Codeine phosphate Winthrop Pharms Co- 8mg + 500mg effervescent oral use Kingdom Pharmaceuticals UK hemihydrate + codamol 8/500 tablet Limited, One Onslow paracetamol effervescent tablets Street, Guildford, Surrey GU1 4YS United Kingdom United SSL INTERNATIONAL Codeine phosphate + SSL International 10mg + 450mg + tablet oral use Kingdom PLC (Reckitt Benckiser paracetamol + Paracetamol, Codeine, 5mg + 30mg Group plc), Wescroft doxylamine succinate + Caffeine & Doxylamine House, Wellcroft Road, caffeine Compound Slough, Berkshire SL1 4AQ United Kingdom

59

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United SSL INTERNATIONAL Codeine phosphate + Syndol 10mg + 30 mg + Film-coated oral use Kingdom PLC (Reckitt Benckiser caffeine + paracetamol 450mg + 5mg tablet Group plc), Wescroft + doxylamine House, Wellcroft Road, succinated Slough, Berkshire SL1 4AQ United Kingdom United SSL INTERNATIONAL Codeine phosphate Ibuprofen and codeine 12.8mg + 200mg tablet oral use Kingdom PLC (Reckitt Benckiser hemihydrate + tablets 200mg/12.8mg Group plc), Wescroft ibuprofen House, Wellcroft Road, Slough, Berkshire SL1 4AQ United Kingdom United Bristol Laboratories Codeine phosphate + Bristol Labs Co-codamol 8mg + 500mg tablet oral use Kingdom Limited, Unit 3, paracetamol Tablets 8mg/500mg Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom United Bristol Laboratories Codeine phosphate Bristol Labs Codeine 15mg tablet oral use Kingdom Limited, Unit 3, Phosphate Tablets 15mg Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom United Bristol Laboratories Codeine phosphate Codeine Phosphate 30mg tablet oral use Kingdom Limited, Unit 3, Tablets BP 30mg Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom

60

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United Bristol Laboratories Codeine phosphate + Co-codamol Tablets 30mg + 500mg tablet oral use Kingdom Limited, Unit 3, paracetamol 30mg/500mg Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom United CRESCENT PHARMA Codeine Co-codamol 500 mg/8 8mg + 500mg tablet oral use Kingdom LTD, Polhampton phosphate+paracetamo mg tablets Lane, Units 3&4, l Quidhampton Business units, Overton, Hampshire, RG25 3ED, United Kingdom United CRESCENT PHARMA Codeine phosphate codeine phosphate 15mg tablet oral use Kingdom LTD, Polhampton tablets BP 15mg Lane, Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED, United Kingdom United CRESCENT PHARMA Codeine phosphate codeine phosphate 30mg tablet oral use Kingdom LTD, Polhampton tablets BP 30mg Lane, Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED, United Kingdom United CRESCENT PHARMA Codeine phosphate codeine phosphate 60mg tablet oral use Kingdom LTD, Polhampton tablets BP 60mg Lane, Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED, United Kingdom

61

Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United CRESCENT PHARMA Codeine Co-codamol 500 mg/8 8mg + 500mg tablet oral use Kingdom LTD, Polhampton phosphate+paracetamo mg tablets Lane, Units 3&4, l Quidhampton Business units, Overton, Hampshire, RG25 3ED, United Kingdom United FANNIN (UK) LIMITED, Codeine Co-codamol 500 mg/30 30mg + 500mg effervescent oral use Kingdom 42-46 Booth Drive, phosphate+paracetamo mg tablets tablet Park Farm South, l Wellingborough NN8 6GT United Kingdom United FANNIN (UK) LIMITED, Codeine Co-codamol 500 mg/8 8mg + 500mg effervescent oral use Kingdom 42-46 Booth Drive, phosphate+paracetamo mg tablets tablet Park Farm South, l Wellingborough NN* 6GT United Kingdom United FANNIN (UK) LIMITED, Codeine Co-codamol 8/500 mg 8mg + 500mg effervescent oral use Kingdom 42-46 Booth Drive, phosphate+paracetamo tablets tablet Park Farm South, l Wellingborough NN* 6GT United Kingdom United FANNIN (UK) LIMITED, Paracetamol + codeine Paracetamol, codeine 500mg + 8mg + effervescent oral use Kingdom 42-46 Booth Drive, phosphate +caffeine 30mg tablet Park Farm South, hemihydrate+ caffeine 500mg/8mg/30mg Wellingborough NN* soluble tablets 6GT United Kingdom

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Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United AUROBINDO PHARMA Codeine phosphate Codeine phosphate 15 15mg tablet oral use Kingdom LIMITED Ares Block, mg tablets Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom United AUROBINDO PHARMA Codeine phosphate Codeine phosphate 30 30mg tablet oral use Kingdom LIMITED Ares Block, mg tablets Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom United AUROBINDO PHARMA Codeine phosphate Codeine phosphate 60 60mg tablet oral use Kingdom LIMITED Ares Block, mg tablets Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom United CONSILIENT HEALTH codeine Co-codamol 30/500 mg 30mg + 500mg effervescent oral use Kingdom LIMITED, 5th floor, phosphate+paracetamo tablets tablet Beaux Lane, Mercer l Street Lower, Dublin 2, Ireland United CONSILIENT HEALTH codeine Co-codamol 8mg + 500mg tablet oral use Kingdom LIMITED, 5th floor, phosphate+paracetamo Beaux Lane, Mercer l Street Lower, Dublin 2, Ireland

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Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United CONSILIENT HEALTH Codeine phosphate Codeine phosphate 15 15mg tablet oral use Kingdom LIMITED, 5th floor, mg tablets Beaux Lane, Mercer Street Lower, Dublin 2, Ireland United CONSILIENT HEALTH Codeine phosphate Codeine phosphate 30 30mg tablet oral use Kingdom LIMITED, 5th floor, mg tablets Beaux Lane, Mercer Street Lower, Dublin 2, Ireland United CONSILIENT HEALTH Codeine phosphate Codeine phosphate 60 60mg tablet oral use Kingdom LIMITED, 5th floor, mg tablets Beaux Lane, Mercer Street Lower, Dublin 2, Ireland United CONSILIENT HEALTH Codeine Cupanol Co-codamol 8mg + 500mg effervescent oral use Kingdom LIMITED, 5th floor, phosphate+paracetamo tablet Beaux Lane, Mercer l Street Lower, Dublin 2, Ireland United Galen Limited, Seogoe Codeine Co-codamol 30mg + 500mg tablet oral use Kingdom Industiral Estate, phosphate+paracetamo 30MG/500MG Craigavon BT 63 5 UA, l United Kingdom United Galen Limited, Seogoe Codeine phosphate Co-codamol 30mg + 500mg capsule, hard oral use Kingdom Industiral Estate, hemihydrate+paraceta 30MG/500MG Craigavon BT 63 5 UA, mol United Kingdom United Galen Limited, Seogoe Codeine phosphate Kapake 15mg/500mg 15mg + 500mg tablet oral use Kingdom Industiral Estate, hemihydrate+paraceta Craigavon BT 63 5 UA, mol United Kingdom

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Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United WOCKHARDT UK Codeine Co-codamol 8MG/500MG 8mg + 500mg tablet oral use Kingdom LIMITED Ash Road phosphate+paracetamo North, Wrexhan l Industrial Estate, Wrexham LL13 9UF, United Kingdom United WOCKHARDT UK Codeine Co-codamol 30mg + 500mg tablet oral use Kingdom LIMITED Ash Road phosphate+paracetamo 30MG/500MG North, Wrexhan l Industrial Estate, Wrexham LL13 9UF, United Kingdom United WOCKHARDT UK Codeine phosphate Codeine phosphate 15 15mg tablet oral use Kingdom LIMITED Ash Road mg tablets North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom United WOCKHARDT UK Codeine phosphate Codeine phosphate 30 30mg tablet oral use Kingdom LIMITED Ash Road mg tablets North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom United WOCKHARDT UK Codeine phosphate Codeine phosphate 60 60mg tablet oral use Kingdom LIMITED Ash Road mg tablets North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom United WOCKHARDT UK codeine Co-codamol 8/500 mg 8mg + 500mg tablet oral use Kingdom LIMITED Ash Road phosphate+paracetamo tablets North, Wrexhan l Industrial Estate, Wrexham LL13 9UF, United Kingdom

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Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United WOCKHARDT UK codeine Co-codamol 30/500 mg 30mg + 500mg tablet oral use Kingdom LIMITED Ash Road phosphate+paracetamo tablets North, Wrexhan l Industrial Estate, Wrexham LL13 9UF, United Kingdom United ACTAVIS GROUP PTC codeine Co-codamol 8/500 mg 8mg + 500mg tablet oral use Kingdom EHF Reykjavikurvegur phosphate+paracetamo tablets 76-78 - 220 l Hafnarfjörður Iceland United MAX REMEDIES Codeine Max Remedies Clear 8mg +500mg + effervescent ORAL USE Kingdom LIMITED, Stoney Gate phosphate+paracetamo Dissolving Pain Relief 30mg tablet House, 2 Greenfield l+caffeine tablets Road, Holmfirth, West Yorkshire, HD9 2JT, United Kingdom United CUSTOM Codeine custom Healthcare co- 8mg + 500mg capsule oral use Kingdom HEALTHCARE, Conway phosphate+paracetamo codamol 8/500mg street,Hove, East l capsules sussex, BN3 3LW United Kingdom United CUSTOM Codeine custom Healthcare co- 8mg + 500mg capsule oral use Kingdom HEALTHCARE, Conway phosphate+paracetamo codamol 8/500mg street,Hove, East l capsules sussex, BN3 3LW United Kingdom United CIPLA (EU) LIMITED, Codeine Co-codamol 8/500 mg 8mg + 500mg tablet oral use Kingdom Hillbrow House, phosphate+paracetamo tablets Hillbrow Road, Esher, l Surrey, KT10 9NW United Kingdom United CIPLA (EU) LIMITED, Codeine Co-codamol 30/500 mg 30mg + 500mg tablet oral use Kingdom Hillbrow House, phosphate+paracetamo tablets Hillbrow Road, Esher, l Surrey, KT10 9NW United Kingdom

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Member Marketing INN Product name Strength Pharmaceutical Route of State (in authorisaton holder form administration EEA) United CIPLA (EU) LIMITED, Codeine STD chemicals 8mg + 500mg + soluble tablet oral use Kingdom Hillbrow House, phosphate+paracetamo paracetamol codeine and 30mg Hillbrow Road, Esher, l + caffeine caffeine Surrey, KT10 9NW United Kingdom United FOURRTS Codeine Co-codamol tablets BP 8mg + 500mg tablet oral use Kingdom (UK)PHARMACARE phosphate+paracetamo LIMITED, 30 Chaul End l Lane, Luton, Bedfordshire, LU4 8EZ, United Kingdom United Globegen Laboratories Codeine Co-codaprin tablets B.P. 8mg + 400mg tablet oral use Kingdom Limtied, 1406 phosphate+Aspirin Coventry Road, Yardley, Birmingham B25 8AE United Kingdom United ZANZA Codeine Zanza Labs holdings Co- 30mg + 500mg effervescent oral use Kingdom LABORATORIES phosphate+paracetamo codamol tablet (HOLDINGS)LIMITED, l Unit 2A Sefton Business Park, Aintree, Liverpool, L30 1RD, United Kingdom United ENNOGEN PHARMA Codeine Ennogen Pharma Co- 8mg +500 mg effervescent oral use Kingdom LIMITED, Unit G4, phosphate+paracetamo codamol tablet Riverside Industrial l Estate, Riverside Way, Dartford, DA1 5BS United Kingdom

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