Codeine Art. 31

26 February 2013 EMA/124076/2013 Patient Health Protection

Annex I

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for codeine containing medicinal products used for pain in children

Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data

Procedure number: EMEA/H/A-31/1342

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

Austria Mundipharma GmbH, Codidol retard 60 mg - Dihydrocodeine 60 mg prolonged- oral use Apollogasse 16 - 18 Filmtabletten release tablet 1070 Vienna Austria Austria Mundipharma GmbH, Codidol retard 90 mg - Dihydrocodeine 90 mg prolonged- oral use Apollogasse 16 - 18 Filmtabletten release tablet 1070 Vienna Austria Austria Mundipharma GmbH, Codidol retard 120 mg - Dihydrocodeine 120 mg prolonged- oral use Apollogasse 16 - 18 Filmtabletten release tablet 1070 Vienna Austria Austria G.L. Pharma GmbH, Dehace retard 60 mg - Dihydrocodeine 60 mg prolonged- oral use Schloßplatz 1 Filmtabletten release tablet 8502 Lannach Austria Austria G.L. Pharma GmbH, Dehace retard 90 mg - Dihydrocodeine 90 mg prolonged- oral use Schloßplatz 1 Filmtabletten release tablet 8502 Lannach Austria Austria G.L. Pharma GmbH, Dehace retard 120 mg - Dihydrocodeine 120 mg prolonged- oral use Schloßplatz 1 Filmtabletten release tablet 8502 Lannach Austria Belgium Laboratoires SMB SA Algocod Paracetamol/ 500 mg/30 mg effervescent oral use rue de la Pastorale 26- Codeine phosphate tablet 28 hemihydrate 1080 Brussels Belgium Belgium Laboratoires SMB SA Algocod Paracetamol/ 500 mg/30 mg powder for oral oral use rue de la Pastorale 26- Codeine phosphate solution 28 hemihydrate 1080 Brussels Belgium

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

Belgium Bristol-Meyers Squibb Dafalgan codeine Paracetamol/ 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 Dafalgan codeine Paracetamol/ 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 Dafalgan codeine Paracetamol/ 500 mg/30 mg tablet oral use Ambachtenlaan 13E Codeine phosphate 3001 Leuven hemihydrate Belgium Belgium Sterop Laboratoires nv Nevrine codeine Paracetamol 500 mg tablet oral use Avenue de Scheut 46- Caffeine 50 mg 50 Codeine phosphate 30 mg 1070 Brussels hemihydrate Belgium Belgium Glaxosmithkline Panadol codeine Paracetamol/ 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 codeine teva Paracetamol/ 500 mg/30 mg dispersible tablet oral use Laarstraat 16 Codeine phosphate 2610 Wilrijk hemihydrate Belgium Belgium Mylan BVBA/SPRL Paracodmylan Paracetamol/ 500 mg/30 mg tablet oral use Terhulpsesteenweg 6A, Codeine phosphate B-1560 Hoeilaart hemihydrate Belgium

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

Bulgaria Actavis EAD Aceffein Acetylsalicylic acid/ 250 mg/50 mg/ 10 tablet oral use 29 Atanas Dukov Str. Caffeine/ mg/ 250 mg Sofia 1407 Codeine phosphate/ Bulgaria Paracetamol Bulgaria Mundipharma DHC Continus Dihydrocodeine tartrate 60 mg modified-release oral use Ges.m.b.H tablet Apollogasse 16-18 Vienna 1072 Austria Bulgaria Mundipharma DHC Continus Dihydrocodeine tartrate 90 mg modified-release oral use Ges.m.b.H tablet Apollogasse 16-18 Vienna 1072 Austria Bulgaria Unipharm JSC Paracofdal Metamizole sodium/ 300 mg/ 200 mg/ tablet oral use Traiko Stanoev str. № 3 Paracetamol/ 30 mg/20 mg Sofia 1797 Caffeine/ Bulgaria Codiene phosphate Bulgaria GlaxoSmithKline Export Solpadeine Paracetamol/ 500 mg/ 8 mg/ 30 soluble tablet oral use Ltd 980 Great West Codeine Phosphate mg Road Brentford Hemihydrate/ Middlesex TW8 9GS Caffeine United Kingdom Bulgaria GlaxoSmithKline Export Solpadeine Paracetamol/ 500 mg/ 8 mg/ 30 capsule, hard oral use Ltd 980 Great West Codeine Phosphate mg Road Brentford Hemihydrate/ Middlesex TW8 9GS Caffeine United Kingdom Cyprus Multi-Pharm Co Ltd, 22 TALVOSILEN TABLET Paracetamol/ 500mg/20mg tablet oral use Philopimenos Str, Codeine phosphate P.O.Box 59522 Lemesos 4010 Cyprus

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

Cyprus Multi-Pharm Co Ltd, 22 TALVOSILEN FORTE Paracetamol/ 1000mg/60mg suppository rectal use Philopimenos Str, SUPPOSITORY Codeine phosphate P.O.Box 59522 Lemesos 4010 Cyprus Cyprus Multi-Pharm Co Ltd, 22 TALVOSILEN FORTE TABLET Paracetamol/ 500mg/30mg tablet oral use Philopimenos Str, Codeine phosphate P.O.Box 59522 Lemesos 4010 Cyprus Cyprus C A Papaellina & Co ltd SOLPADEINE SOLUBLE TABLET Paracetamol/ 500mg/8mg/30mg effervescent oral use 179 Yiannos Kranidiotis Codeine Phosphate tablet ave., P.O.Box 24018 Hemihydrate/ Lefkosia 2235 Caffeine Cyprus Cyprus C A Papaellina & Co ltd SOLPADEINE TABLET Paracetamol/ 500mg/8mg/30mg tablet oral use 179 Yiannos Kranidiotis Codeine Phosphate ave., P.O.Box 24018 Hemihydrate/ Lefkosia 2235 Caffeine Cyprus Cyprus Aegis Ltd, 17 Athinon PARCOTEN TABLET Paracetamol/ 500mg/10mg tablet oral use Street, Ergates Codeine phosphate Industrial Area, P.O.Box 28629 Lefkosia Cyprus Cyprus Boehringer Ingelheim LONARID N SUPPOSITORY Paracetamol+ caffeine+ (400+50+20)mg suppository rectal use Hellas SA codeine phosphate 2 Ellinikou Str hemihydrate 16777,Elliniko, Athens Greece

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

Cyprus Boehringer Ingelheim LONARID N TABLET Paracetamol+ caffeine+ (400+50+10)mg tablet oral use Hellas SA codeine phosphate 2 Ellinikou Str hemihydrate 16777,Elliniko, Athens Greece Cyprus Mundipharma CODANOL TABLET Paracetamol/ 500mg/20mg tablet oral use Pharmaceuticals Ltd, 13 Dihydrocodeine Othellos Str, Dhali Industrial Zone P.O.Box 23661 Lefkosia Cyprus Cyprus Mundipharma DHC CONTINUS PROLONGED Dihydrocodeine tartare 60 mg prolonged- oral use Pharmaceuticals Ltd, 13 RELEASE TABLETS 60MG release tablet Othellos Str, Dhali Industrial Zone P.O.Box 23661 Lefkosia Cyprus Czech Zentiva a.s. CODEIN SLOVAKOFARMA 15 Codeini phosphas 15 mg tablet oral use Republic Nitrianska 100 MG hemihydricus 920 27 Hlohovec Slovak Republic Czech Zentiva a.s. CODEIN SLOVAKOFARMA 30 Codeini phosphas 30 mg tablet oral use Republic Nitrianska 100 MG hemihydricus 920 27 Hlohovec Slovak Republic Czech Zentiva, k.s. KORYLAN Codeini phosphas 28,73 mg + 325 tablet oral use Republic U kabelovny 130 hemihydricus + mg 102 37 Praha 10 paracetamolum Czech Republic Czech Zentiva, k.s. ULTRACOD Codeini phosphas 30 mg + 500 mg tablet oral use Republic U kabelovny 130 hemihydricus + 102 37 Praha 10 paracetamolum Czech Republic

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

Czech bene-Arzneimittel TALVOSILEN Codeini phosphas 20 mg + 500 mg tablet oral use Republic GmbH sesquihydricus + Herterichstrasse 1 paracetamolum 814 79 München Germany Czech bene-Arzneimittel TALVOSILEN FORTE Codeini phosphas 30 mg + 500 mg capsule, hard oral use Republic GmbH hemihydricus + Herterichstrasse 1 paracetamolum 814 79 München Germany Czech GlaxoSmithKline PANADOL ULTRA Codeini phosphas 8 mg + 500 mg + tablet oral use Republic Consumer Healthcare, hemihydricus + 30 mg GlaxoSmithKline Export paracetamolum + Ltd. coffeinum Great West Road 980 Brentford TW8 9GS United Kingdom Czech GlaxoSmithKline PANADOL ULTRA RAPIDE Codeini phosphas 8 mg + 500 mg + effervescent oral use Republic Consumer Healthcare, hemihydricus + 30 mg tablet GlaxoSmithKline Export paracetamolu + Ltd. coffeinum Great West Road 980 Brentford TW8 9GS United Kingdom Czech Zentiva, k.s. SPASMOPAN Codeini phosphas 19,2 mg + 500 mg suppository rectal use Republic U kabelovny 130 hemihydricus + + 10 mg + 0,1 mg 102 37 Praha 10 - Dolní paracetamolum + Měcholupy pitofenoni Czech Republic hydrochloridum + fenpiverinii bromidum Denmark Alternova A/S, Kodein "Alternova" Codeine 25 mg tablet oral use Lodshusvej 11, DK- 4230 Skælskør, Denmark

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

Denmark Nycomed Danmark Kodein "DAK" Codeine 25 mg film-coated tablet oral use ApS, Langebjerg 1, DK- 4000 Roskilde Denmark Denmark Nycomed Danmark Kodein "DAK" Codeine 3 mg/ml oral solution oral use ApS, Langebjerg 1, DK- 4000 Roskilde Denmark Denmark Nycomed Danmark Kodimagnyl "DAK" ASA + codeine 500 mg + 10 mg effervescent oral use ApS, Langebjerg 1, DK- tablet 4000 Roskilde Denmark Denmark Nycomed Danmark Kodein Stærk "DAK" Codeine 8 mg/ml oral solution oral use ApS, Langebjerg 1, DK- 4000 Roskilde Denmark Denmark Nycomed Danmark Kodimagnyl "DAK" ASA + codeine 500 mg + 9,6 mg tablet oral use ApS, Langebjerg 1, DK- 4000 Roskilde Denmark Denmark Nycomed Danmark Kodimagnyl Ikke-stoppende ASA + codeine 500 mg + 9,6 mg film-coated tablet oral use ApS, Langebjerg 1, DK- "DAK" 4000 Roskilde Denmark Denmark Nycomed Danmark Kodipar Codeine + paracetamol 30,6 mg + 500 mg film-coated tablet oral use ApS, Langebjerg 1, DK- 4000 Roskilde Denmark Denmark Amgros I/S, Kodein "SAD" Codeine 25 mg tablet oral use Dampfærgevej 22, DK- 2100 København Ø, Denmark

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

Estonia GlaxoSmithKline Export SOLPADEINE SOLUBLE Paracetamol/Codeine/Caf 500 mg/8 mg/30 effervescent oral use Ltd 980 Great West feine mg tablet Road Brentford Middlesex TW8 9GS United Kingdom Estonia Zentiva, k.s. ALGOCALM Codeine/Paracetamol 30mg/500mg tablet oral use U Kabelovny 130 Dolni Mecholupy 102 37 Prague 10 Czech Republic Estonia GlaxoSmithKline Export SOLPADEINE Paracetamol/Codeine/Caf 500 mg/8 mg/30 tablet oral use Ltd 980 Great West feine mg Road Brentford Middlesex TW8 9GS United Kingdom Estonia Vitabalans Oy PARACETAMOL/CODEINE Codeine/Paracetamol 30mg/500mg tablet oral use Varastokatu 8, VITABALANS 13500 Hämeenlinna Finland Estonia Actavis UK Limited CO-CODAMOL Paracetamol/Codeine 500mg/8mg tablet oral use Whiddon Valley, Barnstaple, Devon, EX32 8NS United Kingdom Finland Ratiopharm Oy CODAXOL Codeine phosphate 30 mg tablet oral use PL 67 Paracetamol 500 mg 02631 Espoo Finland Finland Oy Leiras Finland Ab PAMOL COD Codeine phosphate 30 mg effervescent oral use Paciuksenkatu 21 Paracetamol 500 mg tablet PL 1406 00101 Helsinki Finland

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

Finland Sanofi-aventis Oy PANACOD Codeine phosphate 30 mg tablet oral use Huopalahdentie 24 Paracetamol 500 mg PL 22 00351 Helsinki Finland Finland Sanofi-aventis Oy PANACOD Codeine phosphate 30 mg effervescent oral use Huopalahdentie 24 Paracetamol 500 mg tablet PL 22 00351 Helsinki Finland Finland Bene-Arzneimittel PARACETAMOL/CODEIN Codeine phosphate 30 mg tablet oral use GmbH BENE.ARZNEIMITTEL Paracetamol 500 mg Herterichstrasse 1 81479 München Germany Finland Vitabalans Oy PARAMAX-COD Codeine phosphate 30 mg tablet oral use Varastokatu 8 Paracetamol 500 mg 13500 Hämeenlinna Finland France EG LABO - PARACETAMOL CODEINE EG Paracetamol/Codeine 500 mg/30 mg effervescent oral use Laboratoires 500 mg/30 mg, comprimé tablet EuroGenerics effervescent sécable "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France France Societe Cilfa SEDARENE, gélule Paracetamol/Codeine 300 mg/10 mg capsule oral use Developpement 20, Rue Jean Daudin 75015 – Paris France

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

France Sanofi-Aventis CODOLIPRANE ADULTES 400 Paracetamol/Codeine 400 mg/20 mg tablet oral use France 1-13, mg/20 mg, comprimé sécable Boulevard Romain Rolland 75014 Paris France France Bayer Sante CLARADOL CODEINE 500 Paracetamol/Codeine 500 mg/20 mg tablet oral use Familiale 33, Rue mg/20 mg, comprimé De L'industrie 74240 Gaillard France France Sanofi-Aventis CODOLIPRANE ENFANTS 400 Paracetamol/Codeine 400 mg/20 mg tablet oral use France 1-13, mg/20 mg, comprimé sécable Boulevard Romain Rolland 75014 Paris France France Sanofi-Aventis CODOLIPRANE 500 mg/30 mg, Paracetamol/Codeine 500 mg/30 mg effervescent oral use France 1-13, comprimé effervescent sécable tablet Boulevard Romain Rolland 75014 Paris France France Pierre Fabre KLIPAL CODEINE 600 mg/50 Paracetamol/Codeine 600 mg/50 mg tablet oral use Medicament mg, comprimé 45, Place Abel Gance 92654 Boulogne Cedex France France Bouchara Recordati CODENFAN 1 mg/ml, sirop Codeine 1 mg/ml syrup oral use 68, Rue Marjolin Bp 67 92302 Levallois- Perret Cedex France

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

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 sécable 69007 Lyon France France Gifrer Barbezat8 COMPRALGYL 400 mg/20 mg, Paracetamol/Codeine 400 mg/20 mg tablet oral use 10, Rue Paul Bert comprimé sécable Bp 165 69151 Décines Cedex France France Pierre Fabre KLIPAL CODEINE 300 mg/25 Paracetamol/Codeine 300 mg/25 mg tablet oral use Medicament mg, comprimé 45, Place Abel Gance 92654 Boulogne Cedex France France Teva Sante PARACETAMOL CODEINE TEVA Paracetamol/Codeine 500 mg/30 mg effervescent oral use 110, Esplanade du 500 mg/30 mg, comprimé tablet Général de Gaulle effervescent sécable 92931 Paris La Défense Cedex France France Sanofi-Aventis PARACETAMOL CODEINE Paracetamol/Codeine 500 mg/30 mg effervescent oral use France 1-13, SANOFI-AVENTIS FRANCE 500 tablet Boulevard Romain mg/30 mg, comprimé Rolland effervescent sécable 75014 Paris 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 sécable 92300 Levallois-Perret France

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

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 sécable 92700 Colombes France France Cristers PARACETAMOL CODEINE Paracetamol/Codeine 500 mg/30 mg effervescent oral use 22 quai Gallieni CRISTERS 500 mg/30 mg, tablet 92150 Suresnes comprimé effervescent sécable France France Biogaran PARACETAMOL CODEINE Paracetamol/Codeine 500 mg/30 mg effervescent oral use 15, boulevard Charles BIOGARAN 500 mg/30 mg, tablet de Gaulle comprimé effervescent sécable 92700 Colombes 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 sécable France France Bristol Myers Squibb - DAFALGAN CODEINE, Paracetamol/Codeine 500 mg/30 mg effervescent oral use 3, rue Joseph Monier comprimé effervescent sécable tablet 92500 Rueil-Malmaison France France Bristol Myers Squibb - DAFALGAN CODEINE, Paracetamol/Codeine 500 mg/30 mg coated tablet oral use 3, rue Joseph Monier comprimé pelliculé 92500 Rueil-Malmaison France France Elaiapharm COPRALGIR 400 mg/20 mg, Paracetamol/Codeine 400 mg/20 mg coated tablet oral use 2881, Route des Crêtes comprimé sécable BP 205 Valbonne 06904 Sophia Antipolis Cedex France

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

France Merck Medication GAOSEDAL CODEINE, Paracetamol/Codeine 500 mg/20 mg tablet oral use Familiale comprimé 37, rue Saint-Romain 69379 Lyon Cedex 08 France France Meda Pharma (France) ALGISEDAL, comprimé Paracetamol/Codeine 400 mg/25 mg, tablet oral use 25 boulevard de l'amiral bruix 75016 Paris France France Pharmastra NOVACETOL (ASPIRINE Codeine (Chlorhydrate 10,0 mg / 300,0 tablet oral use 2c, rue du marchal PARACETAMOL), comprimé de) /acétylsalicylique mg/187,5 mg/ 65,1 de lattre de tassigny (acide)/ mg 67460 paracétamol/paracétamol Souffelweyersheim granulé 96 France Germany ALIUD PHARMA GmbH Paracetamol AL comp. codeinphosphat- 30 mg tablet oral use Gottlieb-Daimler-Str. hemihydrat 19 paracetamol 500 mg 89150 Laichingen Germany Germany Aristo Pharma GmbH Azur compositum codeinphosphat- 40 mg suppository rectal use Wallenroder Str. 8-10 hemihydrat 13435 Berlin coffein 50 mg Germany paracetamol 600 mg Germany Aristo Pharma GmbH Azur compositum codeinphosphat- 30 mg tablet oral use Wallenroder Str. 8-10 hemihydrat 13435 Berlin coffein 50 mg Germany paracetamol 350 mg Germany Aristo Pharma GmbH Azur compositum SC codeinphosphat- 30 mg tablet oral use Wallenroder Str. 8-10 hemihydrat 13435 Berlin paracetamol 500 mg Germany

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

Germany Aristo Pharma GmbH Azur compositum SC codeinphosphat- 60 mg suppository rectal use Wallenroder Str. 8-10 Suppositorien hemihydrat 13435 Berlin paracetamol 1000 mg Germany Germany Astellas Pharma GmbH Dolomo TN codeinphosphat- 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 Paracetamol/Codein 500 mg/30 codeinphosphat- 30 mg suppository rectal use GmbH mg bene hemihydrat Herterichstr. 1 - 3 paracetamol 500 mg 81479 München Germany Germany bene - Arzneimittel talvosilen codeinphosphat- 20 mg tablet oral use GmbH hemihydrat Herterichstr. 1 - 3 paracetamol 500 mg 81479 München Germany Germany bene - Arzneimittel talvosilen codeinphosphat- 20 mg capsule oral use GmbH hemihydrat Herterichstr. 1 - 3 paracetamol 500 mg 81479 München Germany Germany bene - Arzneimittel talvosilen 1000 mg/20 mg codeinphosphat- 20 mg suppository rectal use GmbH Zäpfchen hemihydrat Herterichstr. 1 - 3 paracetamol 1000 mg 81479 München Germany Germany bene - Arzneimittel talvosilen 250 mg/5 mg codeinphosphat- 5 mg suppository rectal use GmbH Zäpfchen hemihydrat Herterichstr. 1 - 3 paracetamol 250 mg 81479 München Germany

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

Germany bene - Arzneimittel talvosilen 500 mg/10 mg codeinphosphat- 10 mg suppository rectal use GmbH Zäpfchen hemihydrat Herterichstr. 1 - 3 paracetamol 500 mg 81479 München Germany Germany bene - Arzneimittel talvosilen 500 mg/30 mg codeinphosphat- 30 mg suppository rectal use GmbH hemihydrat Herterichstr. 1 - 3 paracetamol 500 mg 81479 München Germany Germany bene - Arzneimittel talvosilen forte codeinphosphat- 30 mg capsule, hard oral use GmbH hemihydrat Herterichstr. 1 - 3 paracetamol 500 mg 81479 München Germany Germany bene - Arzneimittel talvosilen forte codeinphosphat- 60 mg suppository rectal use GmbH hemihydrat Herterichstr. 1 - 3 paracetamol 1000 mg 81479 München Germany Germany bene - Arzneimittel talvosilen forte codeinphosphat- 30 mg tablet oral use GmbH hemihydrat 500 mg Herterichstr. 1 - 3 paracetamol 81479 München Germany Germany bene - Arzneimittel talvosilen-Saft codeinphosphat- 5 mg/5ml suspension oral use GmbH hemihydrat Herterichstr. 1 - 3 paracetamol 200 mg/5ml 81479 München Germany Germany Berlin-Chemie AG Codeinum phosphoricum codeinphosphat- 30 mg tablet oral use Glienicker Weg 125 Berlin-Chemie hemihydrat 12489 Berlin Germany

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

Germany Berlin-Chemie AG Titretta Schmerztabletten codeinphosphat- 30 mg tablet oral use Glienicker Weg 125 hemihydrat 12489 Berlin paracetamol 500 mg Germany Germany Berlin-Chemie AG Titretta Zäpfchen 1000/60 codeinphosphat- 60 mg suppository rectal use Glienicker Weg 125 hemihydrat 12489 Berlin paracetamol 1000 mg Germany Germany Dr. R. Pfleger Contraneural codeinphosphat- 30 mg tablet oral use Chemische Fabrik Paracetamol/Codein hemihydrat GmbH paracetamol 500 mg Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany Germany Dr. R. Pfleger Contraneural codeinphosphat- 30 mg tablet oral use Chemische Fabrik Paracetamol/Codein 500 mg/30 hemihydrat GmbH mg paracetamol 500 mg Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany Germany Dr. R. Pfleger Optipyrin codeinphosphat- 60 mg suppository rectal use Chemische Fabrik hemihydrat GmbH paracetamol 1000 mg Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany Germany MEDA Manufacturing Dolviran N codeinphosphat- 30 mg tablet oral use GmbH hemihydrat Neurather Ring 1 acetylsalicylsäure 500 mg 51063 Köln Germany

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

Germany Merck Serono GmbH Nedolon P codeinphosphat- 30 mg tablet oral use Alsfelder Str. 17 hemihydrat 64289 Darmstadt paracetamol 500 mg Germany Germany Novartis Pharma GmbH Combaren 50 mg/50 mg codeinphosphat- 50 mg film-coated tablet oral use Roonstr. 25 Filmtabletten hemihydrat 90429 Nürnberg diclofenac-natrium 50 mg Germany Germany Novartis Pharma GmbH Voltaren Plus 50 mg/50 mg codeinphosphat- 50 mg film-coated tablet oral use Roonstr. 25 Filmtabletten hemihydrat 90429 Nürnberg diclofenac-natrium 50 mg Germany Germany OPTIMED Pharma codi OPT codeinphosphat- 60 mg tablet oral use GmbH hemihydrat Alfred-Nobel-Str. 5 50226 Frechen Germany Germany Pfizer Pharma GmbH Gelonida Schmerztabletten codeinphosphat- 30 mg tablet oral use Linkstr. 10 hemihydrat 10785 Berlin paracetamol 500 mg Germany Germany Stadapharm GmbH Paracetamol comp. STADA 500 codeinphosphat- 30 mg tablet oral use Stadastr. 2 - 18 mg/30 mg hemihydrat 61118 Bad Vilbel paracetamol 500 mg Germany Germany Temmler Werke GmbH Dolomo N codeinphosphat- 30 mg tablet oral use Weihenstephaner Str. hemihydrat 28 acetylsalicylsäure 250 mg 81673 München paracetamol 250 mg Germany Greece Boehringer Ingelheim LONARID-N Paracetamol+ Caffeine+ (400+50+20)mg suppository rectal use Hellas SA Codeine phosphate 2 Ellinikou Str hemihydrate 16777,Elliniko, Athens Greece

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

Greece Boehringer Ingelheim LONARID-N Paracetamol+ Caffeine+ (400+50+10)mg tablet oral use Hellas SA Codeine phosphate 2 Ellinikou Str hemihydrate 16777,Elliniko, Athens Greece Greece Boehringer Ingelheim LONALGAL Paracetamol+ Codeine (1000+30)mg suppository rectal use Hellas SA phosphate hemihydrate 2 Ellinikou Str 16777,Elliniko, Athens Greece Greece Boehringer Ingelheim LONALGAL Paracetamol+ Codeine (500+30)mg tablet oral use Hellas SA phosphate hemihydrate 2 Ellinikou Str 16777,Elliniko, Athens Greece Iceland Actavis Group hf. - Pinex Comp Forte Paracetamolum 500 mg/30 mg suppository rectal use Reykjavikurvegur 76-78 INN/Codeini Phosphas - 220 Hafnarfjörður Hemihydricus Iceland Ireland The Boots Company Ibuprofen and Codeine 200 Ibuprofen/Codeine 200 mg/ 12.8 mg film-coated tablet oral use Plc, 1 Thane Road mg/ 12.8 mg film-coated Phosphate Hemihydrate West, NG2 3AA, Tablets Nottingham United Kingdom Ireland Clonmel Healthcare Ltd, Maxilief Effervescent Tablets Paracetamol, 500mg, effervescent oral use Waterford Road, Paracetamol 500mg Codeine Phosphate 500mg, tablet Conmel, Co. Tipperary Codeine Phosphate Hemihydrate, 8mg Ireland Hemihydrate 8mg Caffeine Caffeine 30mg Ireland Sanofi-Aventis Ireland Solpadol Caplets 500 mg/30 Paracetamol 499 mg tablet oral use Limited, Citywest mg Tablets. Codeine Phosphate 30 mg Business Campus, Hemihydrate Dublin 24 Ireland

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 19/66

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

Ireland Sanofi-Aventis Ireland Solpadol 500 mg/30 mg Paracetamol 500 mg effervescent oral use Limited, Citywest Effervescent Tablets Codeine Phosphate 30 mg tablet Business Campus, Hemihydrate Dublin 24 Ireland Ireland GlaxoSmithKline Panadeine Tablets Paracetamol 500mg tablet oral use Consumer Healthcare Paracetamol 500mg Codeine Phosphate 8mg (Ireland) Limited, Codeine Phosphate Hemihydrate Stonemasons Way, Hemihydrate 8mg Rathfarnham, Dublin 16 Ireland Ireland GlaxoSmithKline Panadeine Extra Strength Paracetamol 500mg film-coated tablet oral use Consumer Healthcare Tablets Codeine Phosphate 12.8mg (Ireland) Limited, Paracetamol 500 mg Hemihydrate Stonemasons Way, Codeine Phosphate Rathfarnham, Dublin 16 hemihydrate 12.8 mg Ireland Ireland GlaxoSmithKline Solpadeine Capsules Paracetamol 500mg capsule, hard oral use Consumer Healthcare Paracetamol 500mg Codeine Phosphate 8mg (Ireland) Limited, Codeine Phosphate Hemihydrate 30mg Stonemasons Way, Hemihydrate 8mg Caffeine Rathfarnham, Dublin 16 Caffeine 30mg Ireland Ireland GlaxoSmithKline Solpadeine Soluble Tablets Paracetamol 500mg effervescent oral use Consumer Healthcare Paracetamol 500mg Codeine Phosphate 8mg tablet (Ireland) Limited, Codeine Phosphate Hemihydrate 30mg Stonemasons Way, Hemihydrate 8mg Caffeine Rathfarnham, Dublin 16 Caffeine 30mg Ireland Ireland GlaxoSmithKline Solpadeine Tablets Paracetamol 500mg tablet oral use Consumer Healthcare Paracetamol 500mg, Codeine Codeine Phosphate 8mg (Ireland) Limited, Phosphate Hemihydrate 8mg, Hemihydrate Stonemasons Way, Caffeine 30mg Caffeine 30mg Rathfarnham, Dublin 16 Ireland

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 20/66

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

Ireland GlaxoSmithKline Apfen Plus 200mg / 12.8mg Ibuprofen 200mg film-coated tablet oral use Consumer Healthcare Film-Coated Tablets Codeine Phosphate 12.8mg (Ireland) Limited, Hemihydrate Stonemasons Way, Rathfarnham, Dublin 16 Ireland Ireland McNeil Healthcare Migraleve Pink Film-coated Paracetamol 500mg film-coated tablet oral use (Ireland) Ltd, Airton Tablets. Codeine Phosphate 8mg Road, Tallaght, Dublin Paracetamol 500mg Buclizine Hydrochloride 6.25mg 24 Codeine Phosphate 8mg Ireland Buclizine Hydrochloride 6.25mg Ireland McNeil Healthcare Migraleve Yellow Film-coated Paracetamol 500mg film-coated tablet oral use (Ireland) Ltd, Airton Tablets Codeine Phosphate 8mg Road, Tallaght, Dublin Paracetamol 500mg 24 Codeine phosphate 8mg Ireland Ireland McNeil Healthcare Migraleve Film-coated Tablets Paracetamol 500mg film-coated tablet oral use (Ireland) Ltd, Airton Codeine Phosphate 8mg Road, Tallaght, Dublin Buclizine Hydrochloride 6.25mg 24 Ireland Ireland UCB (Pharma) Ireland Tylex 30 mg / 500 mg Hard Paracetamol 500mg capsule, hard oral use Limited, United Drug Capsules Codeine Phosphate 30mg House, Magna Drive, Hemihydrate Magna Business Park, Citywest Road, Dublin 24 Ireland Ireland UCB (Pharma) Ireland Tylex 30 mg / 500 mg Paracetamol 500mg effervescent oral use Limited, United Drug Effervescent Tablets. Codeine Phosphate 30mg tablet House, Magna Drive, Hemihydrate Magna Business Park, Citywest Road, Dublin 24 Ireland

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 21/66

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

Ireland Reckitt Benckiser Nurofen Plus Tablets Ibuprofen 200mg film-coated tablet oral use Ireland Ltd, 7 Ibuprofen 200mg Codeine Phosphate 12.8mg Riverwalk, Citywest Codeine Phosphate Hemihydrate Business Campus, Hemihydrate 12.8mg Dubin 24 Ireland Ireland SSL International plc, Syndol Film-coated Tablets Paracetamol 450 mg film-coated tablet oral use 103-105 Bath Road, Paracetamol 450 mg Codeine phosphate 10 mg Slough, Berkshire, SL1 Codeine Phosphate hemihydrate 3UH, Hemihydrate 10 mg Doxylamine succinate 5 mg United Kingdom Doxylamine succinate 5 mg Caffeine 30 mg Caffeine 30 mg Ireland Chefaro Ireland Veganin Plus Tablets Paracetamol 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 Kapake 15mg/500mg Tablets Paracetamol 500mg tablet oral use Industiral Estate, Codeine Phosphate 15mg Craigavon BT 63 5 UA, hemihydrate United Kingdom Ireland Galen Limited, Seogoe Kapake 30mg/500mg Tablets Paracetamol 500mg tablet oral use Industiral Estate, Codeine phosphate 30mg Craigavon BT 63 5 UA United Kingdom Ireland Bayer Limited, The Feminax Tablets Paracetamol 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 CO EFFERELGAN paracetamol + codeine 500mg + 30mg effervescent oral use S.A.R.L. phosphate tablet 3 Rue Joseph Monier 92500 Rueil Malmaison France

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 22/66

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

Italy Bristol-Myers Squibb CO EFFERELGAN paracetamol + codeine 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. CODAMOL paracetamol + codeine 500mg + 30mg effervescent oral use Via Meucci, 36 phosphate tablet 56014 Loc. Ospedaletto - Pisa Italy Italy BOEHRINGER LONARID paracetamol + codeine 400mg + 10mg tablet oral use INGELHEIM ITALIA phosphate S.P.A. Via Lorenzini, 8 20139 Milano Italy Italy BOEHRINGER LONARID paracetamol + codeine 400mg + 20mg suppository rectal use INGELHEIM ITALIA phosphate S.P.A. Via Lorenzini, 8 20139 Milano Italy Italy BOEHRINGER LONARID paracetamol + codeine 200mg + 5mg suppository rectal use INGELHEIM ITALIA phosphate S.P.A. Via Lorenzini, 8 20139 Milano Italy Italy Aziende Chimiche TACHIDOL paracetamol + codeine 500mg + 30mg film-coated tablet oral use Riunite Angelini phosphate Francesco ACRAF S.p.A. Viale Amelia 70 00181 Roma Italy

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 23/66

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

Italy Aziende Chimiche TACHIDOL paracetamol + codeine 500mg + 30mg effervescent oral use Riunite Angelini phosphate tablet Francesco ACRAF S.p.A. Viale Amelia 70 00181 Roma Italy Italy Aziende Chimiche TACHIDOL paracetamol + codeine 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 TACHIDOL paracetamol + codeine 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 TACHIDOL paracetamol + codeine 500mg + 30mg film-coated tablet oral use Riunite Angelini phosphate Francesco ACRAF S.p.A. Viale Amelia 70 00181 Roma Italy Italy LABORATORI ALTER PARACETAMOLO E CODEINA paracetamol + codeine 500mg + 30mg effervescent oral use S.R.L. ALTER phosphate tablet Via Egadi, 7 20144 Milano Italy Italy Angenerico S.p.a. 'PARACETAMOLO + CODEINA paracetamol + codeine 500mg + 30mg effervescent oral use Via Nocera Umbra, 75 ANGENERICO granules 00181 Roma Italy

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 24/66

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

Italy Angenerico S.p.a. 'PARACETAMOLO + CODEINA paracetamol + codeine 125 mg + 7,5 mg effervescent oral use Via Nocera Umbra, 75 ANGENERICO granules 00181 Roma Italy Italy Angenerico S.p.a. 'PARACETAMOLO + CODEINA paracetamol + codeine 25 mg/ml + 1,5 syrup oral use Via Nocera Umbra, 75 ANGENERICO mg/ml 00181 Roma Italy Latvia ZENTIVA, k.s., U Ultracod 500 mg/30 mg tablets Paracetamolum/Codeini 500 mg/30 mg tablet oral use Kabelovny 130, Dolní phosphas hemihydricus Měcholupy, 102 37 Praha 10, The Czech Republic Latvia Actavis UK Ltd., Co-Codamol 500 mg/8 mg Paracetamolum/Codeini 500 mg/8 mg tablet oral use Whiddon Valley, tablets phosphas hemihydricus Barnstaple, N Devon, EX32 8NS United Kingdom Latvia GlaxoSmithKline Solpadeine Soluble 500 mg/8 Paracetamolum/Codeini 500 mg/8 mg/30 soluble tablet oral use Consumer Healthcare, mg/30 mg soluble tablets phosphas mg GlaxoSmithKline Export hemihydricus/Coffeinum Limited, Brentford, TW 8 9GS, United Kingdom Latvia GlaxoSmithKline Solpadeine 500 mg/8 mg/30 Paracetamolum/Codeini 500 mg/8 mg/30 tablet oral use Consumer Healthcare, mg tablets phosphas mg GlaxoSmithKline Export hemihydricus/Coffeinum Limited, Brentford, TW 8 9GS, United Kingdom Lithuania ZENTIVA, k.s., U Ultracod Paracetamol/Codeine 500mg/30mg tablet oral use Kabelovny 130, Dolní phosphate hemihydrate Měcholupy, 102 37 Praha 10, The Czech Republic

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 25/66

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

Lithuania GlaxoSmithKline Solpadeine Paracetamol/Codeine/Caf 500mg/8mg/30mg soluble tablet oral use Consumer Healthcare feine GlaxoSmithKline ExportLtd Brentford TW8 9GS United Kingdom Lithuania GlaxoSmithKline Solpadeine Paracetamol/Codeine/Caf 500mg/8mg/30mg tablet oral use Consumer Healthcare feine GlaxoSmithKline ExportLtd Brentford TW8 9GS United Kingdom Luxembourg MEDA PHARMA 25 Algisedal Paracetamol/Codeine 400mg/25mg tablet oral use boulevard de l'amiral phosphate hemihydrate Bruix F-75016 Paris France Luxembourg Laboratoires SMB S.A. Algocod Paracetamol/Codeine 500mg/30mg effervescent oral use Rue de la Pastorale 26- phosphate hemihydrate tablet 28 B 1080 Bruxelles Belgium Luxembourg Laboratoires SMB S.A. Algocod Paracetamol/Codeine 500mg/30mg powder oral use Rue de la Pastorale 26- phosphate hemihydrate 28 B 1080 Bruxelles Belgium Luxembourg Bristol-Myers Squibb Dafalgan codéine Paracetamol/Codeine 500mg/30mg film-coated tablet oral use Belgium S.A. Avenue de phosphate hemihydrate Finlande, 8 B-1420 Braine-l'Alleud Belgium Luxembourg Bristol-Myers Squibb Dafalgan codéine Paracetamol/Codeine 500mg/30mg effervescent oral use Belgium S.A. Avenue de phosphate hemihydrate tablet Finlande, 8 B-1420 Braine-l'Alleud Belgium

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 26/66

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

Luxembourg Meda Pharma Dolviran N Aspirin/Codeine 500mg/30mg tablet oral use GmbH&Co. KG phosphate hemihydrate Benzstr.1 D-61352 Bad Homburg Germany Luxembourg GlaxoSmithKline Panadol codéine Paracetamol/Codeine 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 Paracod Mylan Paracetamol/Codeine 500mg /30mg dispersible tablet oral use Rozendal Businesspark phosphate Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium Luxembourg bene-Arzneimittel Talvosilen forte 500/30 Paracetamol/Codeine 500mg/30mg tablet oral use GmbH Herterichstraße phosphate hemihydrate 1-3 D-81479 München Germany Luxembourg bene-Arzneimittel Talvosilen forte 1000/60 Paracetamol/Codeine 1000mg/60 mg suppository rectal use GmbH Herterichstraße phosphate hemihydrate 1-3 D-81479 München Germany Malta Wockhardt UK Ltd., Ash Codeine Phosphate 30mg Codeine phosphate 30mg tablet oral use Road North Wrexham, Tablets LL13 9 UF, United Kingdom Malta Seton Products Ltd., Syndol Paracetamol 450mg tablet oral use Tubiton House, Medlock Codeine Phosphate 10mg Street, Oldham, OL1 Doxylamine succinate 5mg 3HS, United Kingdom Caffeine 30mg

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 27/66

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

Malta Crookes Healthcare Ltd Nurofen Plus Ibuprofen 200.0mg tablet oral use 1 Thane Road West Codeine phosphate 12.8mg Nottingham NG2 3AA United Kingdom Malta GlaxoSmithKline Solpadeine Soluble Tablets Paracetamol 500mg effervescent oral use Consumer Healthcare Codeine Phosphate 8mg tablet (Ireland) Limited Hemihydrate Stonemasons Way Caffeine 30mg Rathfarnham Dublin 16 Ireland Malta SmithKline Beecham Solpadeine Plus Capsules Paracetamol 500mg capsule, hard oral use (SWG) Limited Codeine Phosphate 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

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 28/66

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

Malta SmithKline Beecham Solpadeine Migraine Ibuprofen Ibuprofen 200.0 mg film-coated tablet oral use (SWG) Limited & Codeine Tablets Codeine phosphate 12.8 mg 980 Great West Road hemihydrate 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 Migraleve Pink Tablets: Migraleve Pink film-coated tablet oral use Foundation Park, Paracetamol, codeine Tablets: 520mg, Roxborough Way, phosphate, buclizine 8mg, 6.25mg Maidenhead, Berkshire hydrochloride SL6 3UG Migraleve Yellow Tablets: Migraleve Yellow United Kingdom Paracetamol, codeine Tablets: 520mg, phosphate 8mg Malta McNeil Products Ltd., Migraleve Yellow Paracetamol/codeine 520mg/8mg film-coated tablet oral use Foundation Park, phosphate Roxborough Way, Maidenhead, Berkshire SL6 3UG United Kingdom Malta M&A Pharmachem Co-Codamol Tablets BP Paracetamol/codeine 500mg/8mg tablet oral use Limited, Allenby 8/500mg phosphate Laboratories, Wigan Road, Westhoughton Bolton BL5 2AL United Kingdom Norway Vitabalans Oy, Paramax Comp Paracetamol/ Codein 500 mg/30 mg tablet oral use Varastokatu 8, 13500 phosphate hemihydrate Hameenlinna Finland.

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 29/66

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

Norway ratiopharm Oy- Teva Codaxol Paracetamol/ Codein 500 mg/30 mg tablet oral use Group Menmber, phosphate hemihydrate Keilaranta 10 E, 02150 Espoo, Finland Norway Actavis Group hf. - Pinex Forte Paracetamol/ Codein 500 mg/30 mg effervescent oral use Reykjavikurvegur 76-78 phosphate hemihydrate tablet - 220 Hafnarfjörður Iceland Norway Actavis Group hf. - Pinex Forte Paracetamol/ Codein 500 mg/30 mg tablet oral use Reykjavikurvegur 76-78 phosphate hemihydrate - 220 Hafnarfjörður Iceland Norway Actavis Group hf. - Pinex Forte Paracetamol/ Codein 500 mg/30 mg suppository rectal use Reykjavikurvegur 76-78 phosphate hemihydrate - 220 Hafnarfjörður Iceland Norway Weifa AS, Paralgin Forte Paracetamol/ Codein 400mg/30 mg suppository rectal use Hausmannsgate 6, phosphate sesquihydrate P.O.Box 9113 Grønland, NO-0133 Oslo, Norway Norway Weifa AS, Paralgin Minor Paracetamol/ Codein 200mg/15 mg suppository rectal use Hausmannsgate 6, phosphate sesquihydrate P.O.Box 9113 Grønland, NO-0133 Oslo, Norway Norway Weifa AS, Paralgin Major Paracetamol/ Codein 800mg/60 mg suppository rectal use Hausmannsgate 6, phosphate sesquihydrate P.O.Box 9113 Grønland, NO-0133 Oslo, Norway

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 30/66

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

Norway Weifa AS, Paralgin Forte Paracetamol/ Codein 400mg/30 mg tablet oral use Hausmannsgate 6, phosphate sesquihydrate P.O.Box 9113 Grønland, NO-0133 Oslo, Norway Poland Bristol-Myers Squibb Efferalgan Codeine Paracetamolum + 500mg + 30mg effervescent oral use Polska Sp. z o.o. Codeini phosphas tablet Al. Armii Ludowej 26 00-609 Warszawa Poland Poland bene Arzneimittel Talvosilen Forte Paracetamolum + 500mg + 30mg capsule oral use GmbH Codeini phosphas Herterichstrasse 1 hemihydricus D-81479 Munchen Germany Poland bene Arzneimittel Talvosilen Paracetamolum + 500mg + 20mg tablet oral use GmbH Codeini phosphas Herterichstrasse 1 hemihydricus D-81479 Munchen Germany Poland Norpharma A/S DHC Continus Dihydrocodeini tartras 60 mg modified-release oral use Slotsmarken 15 tablet DK-2970 Horsholm Denmark Poland Norpharma A/S DHC Continus Dihydrocodeini tartras 90 mg modified-release oral use Slotsmarken 15 tablet DK-2970 Horsholm Denmark Poland Norpharma A/S DHC Continus Dihydrocodeini tartras 120 mg modified-release oral use Slotsmarken 15 tablet DK-2970 Horsholm Denmark

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 31/66

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

Poland Bristol-Myers Squibb Dafalgan codeine Paracetamolum + 500mg + 30mg film-coated tablet oral use Polska Sp. z o.o. Codeini phosphas Al. Armii Ludowej 26 00-609 Warszawa Poland Poland Zentiva, k.s. Ultracod Paracetamolum + 500mg + 30mg tablet oral use U kabelovny 130 Codeini phosphas Praha 10 hemihydricus 10237 Dolni Mecholupy Czech Republic Poland Vitabalans Oy Paramax-Cod Paracetamolum + 500mg + 30mg tablet oral use Varastokatu 8 Codeini phosphas FIN-13500 hemihydricus Hameenlinna Finland Poland Zakłady Ascodan Acidum acetylsalicylicum 400mg + 8mg tablet oral use Farmaceutyczne + Codeini phosphas POLPHARMA S.A. ul. Pelplińska 19 Starogard Gdański 83-200 Poland Poland Reckitt Benckiser Nurofen Plus Ibuprofenum + Codeini 200mg + 12,8mg film-coated tablet oral use (Poland) S.A. phosphas Okunin 1 Nowy Dwór Mazowiecki 05-100 Poland Poland OMEGA Pharma Poland Solpadeine Paracetamolum + 500mg + 8mg + capsule oral use Sp. z o.o. Codeini phosphas + 30mg Niepodleglosci 18 Coffeinum 02-653 Warsaw Poland

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 32/66

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

Poland OMEGA Pharma Poland Solpadeine Paracetamolum + 500mg + 30mg + effervescent oral use Sp. z o.o. Coffeinum + Codeini 8mg tablet Niepodleglosci 18 phosphas 02-653 Warsaw Poland Poland OMEGA Pharma Poland Solpadeine Paracetamolum + 500mg + 8mg + tablet oral use Sp. z o.o. Codeini phosphas + 30mg Niepodleglosci 18 Coffeinum 02-653 Warsaw Poland Portugal Bayer Portugal, S.A. Dolviran Acetylsalicylic acid + 400mg + 9.6mg + tablet oral use Rua Quinta do Pinheiro Codeine phosphate 50mg 5 2794-003 hemihydrate + Caffeine Carnaxide Portugal Portugal Bayer Portugal, S.A. Dolviran Acetylsalicylic acid + 400mg + 9.6mg + suppository rectal use Rua Quinta do Pinheiro Codeine phosphate 50mg 5 2794-003 hemihydrate + Caffeine Carnaxide Portugal Portugal Johnson & Johnson, Migraleve Paracetamol + Codeine 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 CODEINA FABIOL 15 mg codeinum 15 mg tablet oral use Timişoara nr. 50, Bucureşti, 61333 Romania Romania S.C. LaborMed Pharma CODEINA FOSFAT LPH 15 mg codeinum 15 mg tablet oral use S.A.,B-dul Theodor Pallady nr. 44 B,sector 3, 032266 Bucureşti, Romania

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 33/66

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

Romania S.C. SINTOFARM FOSFAT DE CODEINA 15 mg codeinum 15 mg tablet oral use S.A.Str. Ziduri între Vii nr.22, Bucureşti, sector 3, 023324 Romania Romania S.C. Farmacom S.A. FARMACOD codeinum 15 mg tablet oral use Str. Zizinului Nr. 112, 2200 Braşov, 500407 Romania Romania S.C. MAGISTRA C & C CODEINA FOSFAT MCC 15 mg codeinum 15 mg tablet oral use S.R.L.Bd-ul Aurel Vlaicu nr. 82 A, Constanţa, Romania Romania S.C. Slavia Pharm CODEINA FOSFAT codeinum 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. CODEINA FOSFORICA codeinum 15 mg tablet oral use Bega Nr. 4, Târgu- Mureş, 540390 Romania Romania GEDEON RICHTER FASCONAL acid acetilsalicilic, 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. ASPACO acid acetilsalicilic, 300mg + 250mg tablet oral use Bega Nr. 4, Târgu- paracetamol , fosfat de + 12mg Mureş, 540390 codeină hemihidrat Romania

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 34/66

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

Romania HIPOCRATE 2000 S.R.L. SOLPADEINE 500 mg/8 mg/30 paracetamol, fosfat de 500 mg+8 mg+30 effervescent oral use Str. Prahova, Nr. 6A, mg comprimate efervescente codeină hemihidrat, mg tablet Sector 1, Bucureşti cafeină anhidră 012423 Romania Romania HIPOCRATE 2000 S.R.L. SOLPADEINE COMPRIMATE paracetamol, fosfat de 500 mg+8 mg+30 tablet oral use Str. Prahova, Nr. 6A, codeină hemihidrat, mg Sector 1, Bucureşti cafeină anhidră 012423 România Romania S.C. TERAPIA S.A CODAMIN P paracetamol, cafeină 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 CAFFETIN paracetamol, 250mg+ tablet oral use Šlandrova ulica 4, 1231 propifenazonă , cafeină , 210mg+50mg+10 Ljubljana - Črnuče, fosfat de codeină mg Slovenia sesquihidrat Romania Zentiva, k.s.U ULTRACOD 500 mg/30 mg paracetamolum+ 500mg/30mg tablet oral use kabelovny 130, Dolní codeinum Měcholupy 102 37, Praga 10, Czech Republic Romania RECKITT BENCKISER NUROFEN PLUS ibuprofen, fosfat de 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. Alnagon Neo acetylsalicylic acid + 380 mg + 20 mg tablet oral use Republic Nitrianska 100, (Zentiva) codeine + caffeine +80 mg Hlohovec 920 27 Slovak Republic

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

Slovak Zentiva a.s. Codein-SLOVAKOFARMA 15 mg codeine 15 mg tablet oral use Republic Nitrianska 100, Hlohovec 920 27 Slovak Republic Slovak Zentiva a.s. Codein-SLOVAKOFARMA 30 mg codeine 15 mg tablet oral use Republic Nitrianska 100, Hlohovec 920 27 Slovak Republic Slovak Zentiva k.s. Korylan codeine + paracetamol 21,17 mg +325 mg tablet oral use Republic U kabelovny 130, Praha 102 37 Czech Republic Slovak GlaxoSmithKline Panadol Ultra, Panadol Ultra codeine + paracetamol + 8 mg+500 mg +30 capsule, tablet, oral use Republic Consumer Healthcare, Rapide caffeine mg effervescent GlaxoSmithKline Export tablet Ltd. 980 Great West Road, TW8 9GS Brentford United Kingdom Slovak Vitabalans Oy Paramax-Cod codeine + paracetamol 30 mg +500 mg tablet oral use Republic Varastokatu 8, (Vitabalans) Hämeenlinna FI-13500 Finland Slovak Zentiva k.s. Spasmopan codeine + paracetamol + 19,2 mg+500 suppository rectal use Republic U kabelovny 130, Praha fenpiverine + pitofenon mg+0,1 mg +10 102 37 mg Czech Republic Slovenia Alkaloid-Int. d.o.o. Caffetin tablete codeine, paracetamol, 10 mg, 250 mg, tablet oral use Šlandrova 4, propyphenazone, caffeine 210 mg, 50 mg 1231 Ljubljana- Črnuče Slovenia Slovenia Pliva Ljubljana d.o.o., Plivadon tablete codeine, paracetamol, 10 mg, 210 mg, tablet oral use Pot k sejmišču 35, propyphenazone, caffeine 250 mg, 25 mg 1000 Ljubljana, Slovenia

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

Spain TEVA PHARMA, S.L.U. CODEISAN COMPRIMIDOS Codeine phosphate 28,7 mg tablet oral use C/ Anabel Segura, 11 hemihydrate Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain Spain TEVA PHARMA, S.L.U. CODEISAN JARABE Codeine phosphate 6,33 mg/ 5 ml oral solution oral use C/ Anabel Segura, 11 hemihydrate Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain Spain VIFOR PHARMA DOLMEN Acetylsalicylic acid, 500 mg, 10 mg effervescent oral use ESPAÑA, S.L. codeine phosphate and 250 mg tablet Avda. Camí Real, 51-57 hemihydrate and 08184 Palau-Solitá i ascorbic acid Plegamans (Barcelona) Spain Spain LABORATORIOS DOLODENS GRAGEAS Codeine phosphate, 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. CALMOPLEX 200 mg/ 10 mg/ Codeine phosphate, 10 mg, 10 mg and coated tablet oral use Vía F. Lli Cervi, 8 10 mg comprimidos recubiertos hidroxicine 200 mg 27010 Valle Sambrene dichlorhydrate and (Pavia) propifenazone Italy

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 37/66

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

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

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 38/66

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

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

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 39/66

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

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

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 40/66

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

Spain KERN PHARMA, S.L. PARACETAMOL/CODEÍNA KERN Paracetamol and codeine 500 mg and 30 mg tablet oral use Venus, 72 PHARMA 500 mg/ 30 mg phosphate hemihydrate Polígono Industrial comprimidos EFG Colon II 08228 Tarrasa (Barcelona) Spain Spain KERN PHARMA, S.L. PARACETAMOL/CODEÍNA Paracetamol and codeine 500 mg and 30 mg tablet oral use Venus, 72 PHARMAKERN 500 mg/ 30 mg phosphate hemihydrate Polígono Industrial comprimidos EFG Colon II 08228 Tarrasa (Barcelona) Spain Spain NOVARTIS CONSUMER TERMALGIN CODEINA 650 Paracetamol and 650 mg and 28,09 suppository rectal use HEALTH, S.A. mg/30 mg supositorios anhidrous codeine mg Gran Vía de les Corts phosphate Catalanes, 764 08013 Barcelona Spain Spain NOVARTIS CONSUMER TERMALGIN CODEINA 300 Paracetamol and 300 mg and 14,05 capsule, hard oral use HEALTH, S.A. mg/15 mg cápsulas anhidrous codeine mg Gran Vía de les Corts phosphate Catalanes, 764 08013 Barcelona Spain Spain LABORATORIOS ALTER, FLUDETEN comprimidos Paracetamol and codeine 500 mg and 30 mg effervescent oral use S.A. efervescentes phospate tablet Mateo Inurria, 30 28036 Madrid Spain

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 41/66

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

Spain LABORATORIOS MIGRALEVE comprimidos Paracetamol, Buclizine 500 mg, 6,25 mg, tablet oral use LLORENS, S.A. chlorhidrate, codeine 8 mg and 10 mg Ciudad de Balaguer, 7- phosphate and docusate 11 08022 sodium Barcelona Spain Sweden BioPhausia AB Citodon minor Kodein/Paracetamol 350mg/15mg suppository rectal use Blasieholmsgatan 2 111 48 Stockholm Sweden Sweden BioPhausia AB Citodon forte Kodein/Paracetamol 1000mg/60 mg suppository rectal use Blasieholmsgatan 2 111 48 Stockholm Sweden Sweden BioPhausia AB Citodon Kodein/Paracetamol 500 mg/30 mg tablet oral use Blasieholmsgatan 2 111 48 Stockholm Sweden Sweden BioPhausia AB Citodon Kodein/Paracetamol 500 mg/30 mg suppository rectal use Blasieholmsgatan 2 111 48 Stockholm Sweden Sweden BioPhausia AB Citodon Kodein/Paracetamol 500 mg/30 mg effervescent oral use Blasieholmsgatan 2 tablet 111 48 Stockholm Sweden Sweden Meda AB Treo® comp codeine phosphate 500mg/50mg/30m effervescent oral use Box 906 hemihydrate/caffeine/ g tablet 170 09 Solna acetylsalicylic acid Sweden Sweden Meda AB Codalvonil codeine phosphate 500 mg/30 mg effervescent oral use Box 906 hemihydrate/ tablet 170 09 Solna paracetamol Sweden

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 42/66

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

Sweden sanofi-aventis AB Panocod® codeine phosphate 500 mg/30 mg tablet oral use Box: 14142 hemihydrate/ 167 14 Bromma paracetamol Sweden Sweden sanofi-aventis AB Panocod® codeine phosphate 500 mg/30 mg effervescent oral use Box: 14142 hemihydrate/ tablet 167 14 Bromma paracetamol Sweden Sweden Recip AB Kodein Recip codeine phosphate 25mg tablet oral use Box: 906 hemihydrate 170 09 Solna Sweden Sweden Mundipharma AB, Ardinex® ibuprofen/codeine 200 mg/30 mg tablet oral use Mölndalsvägen 30 phosphate hemihydrate 412 63 Göteborg Sweden Sweden Evolan Pharma AB Paracetamol/Kodein Evolan codeine phosphate 500 mg/30 mg effervescent oral use Box: 120 hemihydrate/ tablet 182 12 Danderyd paracetamol Sweden Sweden Evolan Pharma AB Paracetamol/Kodein Evolan codeine phosphate 500 mg/30 mg tablet oral use Box: 120 hemihydrate/ 182 12 Danderyd paracetamol Sweden Sweden Meda AB Spasmofen codeine hydrochloride 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 hydrochloride, 3 mg hyoscine methonitrate, (in each ml) noscapine hydrochloride

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 43/66

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

Sweden Meda AB Spasmofen codeine hydrochloride 0,8mg, suppository rectal use Box 906 dihydrate, 40 mg, 170 09 Solna papaverine 13 mg, Sweden hydrochloride, 0,5 mg, morphine hydrochloride, 6 mg hyoscine methonitrate, noscapine hydrochloride The ratiopharm Nederland Paracetamol/Codeinefosfaat Paracetamol 500 mg tablet oral use Netherlands B.V. ratiopharm 500 mg/20 mg, Codeine 20 mg Florapark 4 tabletten 2012 HK Haarlem The Netherlands The Pharmachemie B.V. Codeine HCl 10 PCH, tabletten Codeine 10 mg tablet oral use Netherlands Swensweg 5 10 mg 2031 GA Haarlem The Netherlands The Pharmachemie B.V. Codeine HCl 20 PCH, tabletten Codeine 20 mg tablet oral use Netherlands Swensweg 5 20 mg 2031 GA Haarlem The Netherlands The ratiopharm Nederland Codeinefosfaat ratiopharm 10 Codeine 10 mg tablet oral use Netherlands B.V. mg, tabletten Florapark 4 2012 HK Haarlem The Netherlands The ratiopharm Nederland Codeinefosfaat ratiopharm 20 Codeine 20 mg tablet oral use Netherlands B.V. mg, tabletten Florapark 4 2012 HK Haarlem The Netherlands The Pharmachemie B.V. Codeinefostaat 10 PCH, Codeine 10 mg tablet oral use Netherlands Swensweg 5 tabletten 10 mg 2031 GA Haarlem The Netherlands

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 44/66

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

The Pharmachemie B.V. Codeinefostaat 15 PCH, Codeine 15 mg tablet oral use Netherlands Swensweg 5 tabletten 15 mg 2031 GA Haarlem The Netherlands The Pharmachemie B.V. Codeinefostaat 20 PCH, Codeine 20 mg tablet oral use Netherlands Swensweg 5 tabletten 20 mg 2031 GA Haarlem The Netherlands The Pharmachemie B.V. Paracetamol/Codeinefosfaat Paracetamol 500 mg tablet oral use Netherlands Swensweg 5 500/20 PCH, tabletten 500 Codeine 20 mg 2031 GA Haarlem mg/20 mg The Netherlands The Pharmachemie B.V. Paracetamol/Codeinefosfaat Paracetamol 500 mg tablet oral use Netherlands Swensweg 5 500/50 PCH, tabletten 500 Codeine 50 mg 2031 GA Haarlem mg/50 mg The Netherlands The Apotex Europe B.V. Paracetamol/codeinefosfaat Paracetamol 500 mg tablet oral use Netherlands Darwinweg 20 Apotex 500/10 mg, tabletten Codeine 10 mg 2333 CR Leiden The Netherlands The Apotex Europe B.V. Paracetamol/codeinefosfaat Paracetamol 500 mg tablet oral use Netherlands Darwinweg 20 Apotex 500/20 mg, tabletten Codeine 20 mg 2333 CR Leiden The Netherlands The Pharmachemie B.V. Paracetamol/Codeinefosfaat Paracetamol 500 mg tablet oral use Netherlands Swensweg 5 500/10 PCH, tabletten 500 Codeine 10 mg 2031 GA Haarlem mg/10 mg The Netherlands The ratiopharm Nederland Paracetamol/Codeinefosfaat Paracetamol 500 mg tablet oral use Netherlands B.V. ratiopharm 500 mg/10 mg, Codeine 10 mg Florapark 4 tabletten 2012 HK Haarlem The Netherlands

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 45/66

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

The Pharmachemie B.V. A.C. Cod., suppositoria Acetylsalicylacid 400 mg suppository rectal use Netherlands Swensweg 5 Codeine 9.6 mg 2031 GA Haarlem Caffeine 50 mg The Netherlands United Bayer plc, Bayer House, Co-Codamol Disp paracetamol + codeine 500mg + 8mg tablet for oral oral use Kingdom Strawberry Hill, solution Newbury, Berkshire RG14 1JA, United Kingdom United Bayer plc, Bayer House, Paracodol Capsules paracetamol + codeine 500mg + 8mg capsule oral use Kingdom Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom United Bayer plc, Bayer House, Paracodol Tablets paracetamol + codeine 500mg + 8mg tablet for oral Oral use Kingdom Strawberry Hill, solution Newbury, Berkshire RG14 1JA, United Kingdom United Bayer plc, Bayer House, Bayer Co-Codamol 8/500mg paracetamol + codeine 500mg + 8mg capsule, hard Oral use Kingdom Strawberry Hill, capsules Newbury, Berkshire RG14 1JA, United Kingdom United The Boots Company Boots Aspirin and Codeine aspirin + codeine 400mg + 8mg tablet Oral use Kingdom Plc, 1 Thane Road Tablets phosphate West, NG2 3AA, Nottingham, United Kingdom United The Boots Company Paracetamol and Codeine paracetamol + codeine 500mg + 8mg tablet Oral use Kingdom Plc, 1 Thane Road Caplets West, NG2 3AA, Nottingham, United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 46/66

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

United The Boots Company Boots Pain Relief Plus Capsules paracetamol + codeine 500mg + 8mg capsule Oral use Kingdom Plc, 1 Thane Road West, NG2 3AA, Nottingham, United Kingdom United The Boots Company Boots Paracetamol and Codeine paracetamol + codeine + 500mg + 8mg + capsule, hard Oral use Kingdom Plc, 1 Thane Road Extra Capsules caffeine 30mg West, NG2 3AA, Nottingham, United Kingdom United The Boots Company Boots Ibuprofen and Codeine ibuprofen + codeine 200mg +12.8mg film-coated tablet Oral use Kingdom Plc, 1 Thane Road Tablets West, NG2 3AA, Nottingham, United Kingdom United UCB Pharma Limited, Tylex Tablets paracetamol + codeine 500mg + 8mg coated tablet oral use Kingdom 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom United UCB Pharma Limited, Medocodene 30/500 Capsules paracetamol + codeine 500mg + 30mg capsule oral use Kingdom 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom United UCB Pharma Limited, Tylex 30/500 Effervescent paracetamol + codeine 500mg + 30mg effervescent oral use Kingdom 208 Bath Road, Slough, tablet Berkshire SL1 3WE, United Kingdom United Reckitt Benkiser Codis 500 Tablets paracetamol + codeine 500mg + 8mg tablet for oral oral use Kingdom Healthcare (UK) solution Limited, Wellcroft House, Wellcroft Road, Slough, Berkshire SL1 4AQ, United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 47/66

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

United Reckitt Benkiser Nurofen Plus ibuprofen + codeine 200mg +12.8mg coated tablet oral use Kingdom Healthcare (UK) Limited, Wellcroft House, Wellcroft Road, Slough, Berkshire SL1 4AQ, United Kingdom United Omega Pharma Limited Solpadeine Plus Capsules paracetamol + codeine + 500mg + 8mg + capsule oral use Kingdom 32 Vauxhall Bridge caffeine 30mg Road London SW1V 2SA United Kingdom United Omega Pharma Limited Solpadeine Max paracetamol + codeine 500mg + 12.8mg tablet oral use Kingdom 32 Vauxhall Bridge Road London SW1V 2SA United Kingdom United Omega Pharma Limited Solpadeine Max Soluble Tablets paracetamol + codeine + 500mg + 12.8mg effervescent oral use Kingdom 32 Vauxhall Bridge caffeine + 30mg tablet Road London SW1V 2SA United Kingdom United Omega Pharma Limited Solpadeine Plus Soluble Tablets paracetamol + codeine + 500mg +8mg + tablet for oral oral use Kingdom 32 Vauxhall Bridge caffeine 30mg solution Road London SW1V 2SA United Kingdom United Omega Pharma Limited Solpadeine Plus Tablets paracetamol + codeine + 500mg +8mg + tablet oral use Kingdom 32 Vauxhall Bridge caffeine 30mg Road London SW1V 2SA United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 48/66

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

United Omega Pharma Limited Solpaflex Tablets ibuprofen +codeine 200mg +12.8mg film-coated tablet oral use Kingdom 32 Vauxhall Bridge Road London SW1V 2SA United Kingdom United Omega Pharma Limited Solpadeine Max Tablets paracetamol + codeine 500mg + 12.8mg film-coated tablet oral use Kingdom 32 Vauxhall Bridge Road London SW1V 2SA United Kingdom United Actavis UK Limited Dispersible Co-Codaprin Tablets aspirin + codeine 400mg + 8mg tablet for oral oral use Kingdom Whiddon Valley, BP phosphate solution Barnstaple, Devon, EX32 8NS United Kingdom United Actavis UK Limited Cox Co-Codamol Tablets paracetamol + codeine 500mg + 8mg tablet oral use Kingdom Whiddon Valley, Barnstaple, Devon, EX32 8NS United Kingdom United Actavis UK Limited Cox Codeine Phosphate Tablets codeine phosphate 15mg tablet oral use Kingdom Whiddon Valley, BP 15mg Barnstaple, Devon, EX32 8NS United Kingdom United Actavis UK Limited Codeine Phosphate Tablets BP codeine phosphate 30mg tablet oral use Kingdom Whiddon Valley, 30mg Barnstaple, Devon, EX32 8NS United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 49/66

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

United Actavis UK Limited Codeine Phosphate Tablets BP codeine phosphate 60mg tablet oral use Kingdom Whiddon Valley, 60mg Barnstaple, Devon, EX32 8NS United Kingdom United Teva UK Limited, Teva UK Co-Codamol Tablets paracetamol + codeine 500mg + 8mg tablet oral use Kingdom Brampton Road, 8/500 Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom United Teva UK Limited, Codeine Phosphate Tablets BP codeine phosphate 15mg tablet oral use Kingdom Brampton Road, 15mg Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom United Teva UK Limited, Codeine Phosphate Tablets BP codeine phosphate 30mg tablet oral use Kingdom Brampton Road, 30mg Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom United Teva UK Limited, Codeine Phosphate Tablets BP codeine phosphate 60mg tablet oral use Kingdom Brampton Road, 60mg Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom United Macarthy's Laboratories Macarthy's Codeine Phosphate codeine phosphate 6.1% w/v Solution for intramuscular Kingdom Limited, Bampton Road, Injection BP 60mg/ml Injection Harold Hill, Romford, Esses RM3 8UG, United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 50/66

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

United Chefaro UK Limited, 3 Veganin paracetamol + codeine + 500mg + 8mg + film-coated tablet oral use Kingdom Percy Road, Huntingdon caffeine 30mg PE29 6SZ, United Kingdom United M & A Pharmachem Pharmachem Co-Codamol paracetamol + codeine 500mg + 8mg tablet oral use Kingdom Limited, Allenby Tablets 8/500 Laboratories, Wigan Road, Westhoughton, Bolton, Lancashire BL5 2AL, United Kingdom United M & A Pharmachem M&A Pharmachem Co-Codamol paracetamol + codeine 500mg + 30mg tablet oral use Kingdom Limited, Allenby Tablets 30/500 Laboratories, Wigan Road, Westhoughton, Bolton, Lancashire BL5 2AL, United Kingdom United M & A Pharmachem M&A Pharmachem Co-Codamol paracetamol + codeine 500mg + 60mg tablet oral use Kingdom Limited, Allenby Tablets 60/500 Laboratories, Wigan Road, Westhoughton, Bolton, Lancashire BL5 2AL, United Kingdom United Sandoz Limted, Frimley Codeine Phosphate Tablets BP codeine phosphate 15mg tablet oral use Kingdom Business Park, Frimley, 15mg Camberley, Surrey GU16 7SR, United Kingdom United Sandoz Limted, Frimley Codeine Phosphate Tablets BP codeine phosphate 30mg tablet oral use Kingdom Business Park, Frimley, 30mg Camberley, Surrey GU16 7SR, United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 51/66

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

United Sandoz Limted, Frimley Codeine Phosphate Tablets BP codeine phosphate 60mg tablet oral use Kingdom Business Park, Frimley, 60mg Camberley, Surrey GU16 7SR, United Kingdom United Sandoz Limted, Frimley Propain Plus Tablets paracetamol + 450mg + 5mg + tablet oral use Kingdom Business Park, Frimley, doxylamine succinate + 30mg + 10 mg Camberley, Surrey caffeine + codeine GU16 7SR, United Kingdom United Sandoz Limted, Frimley Propain tablets paracetamol + 400mg + 5mg + tablet oral use Kingdom Business Park, Frimley, diphenhydramine 50mg + 10mg Camberley, Surrey hydrochloride + caffeine GU16 7SR, + codeine United Kingdom United Sandoz Limted, Frimley Sandoz Co-Codamol Tablets paracetamol + codeine 500mg + 30mg tablet oral use Kingdom Business Park, Frimley, 30/500mg Camberley, Surrey GU16 7SR, United Kingdom United Aventis Pharma Aventis Pharam Co-codamol Codeine phosphate + 30mg + 500 mg capsule, hard oral use Kingdom Limited, One Onslow Capsules 30mg/500mg paracetamol Street, Guilford, Surrey GU1 4SY United Kingdom United Aventis Pharma Solpadol Tablets Codeine phosphate + 30mg + 500 mg effervescent Oral use Kingdom Limited, One Onslow paracetamol tablet Street, Guilford, Surrey GU1 4SY United Kingdom United Aventis Pharma Solpadol Tablets Codeine phosphate + 30mg + 500 mg tablet Oral use Kingdom Limited, One Onslow paracetamol Street, Guilford, Surrey GU1 4SY United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 52/66

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

United Waymade Plc, Waymade codeine phosphate Codeine phosphate 15mg tablet Oral use Kingdom Sovereign House, Miles tablets 15mg Gray Road, Basildon, Essex SS14 3FR United Kingdom United Waymade Plc, Codeine phosphate 30mg Codeine phosphate 30mg tablet Oral use Kingdom Sovereign House, Miles tablets Gray Road, Basildon, Essex SS14 3FR United Kingdom United Waymade Plc, Codeine phosphate 60mg Codeine phosphate 60mg tablet Oral use Kingdom Sovereign House, Miles tablets Gray Road, Basildon, Essex SS14 3FR United Kingdom United Ranbaxy Ireland Codeine phosphate tablets BP Codeine phosphate 15mg tablet Oral use Kingdom Limited, Spafield, Cork 15mg Road, Cashel, Co. Tipperary Ireland United Ranbaxy Ireland Codeine phosphate tablets BP Codeine phosphate 30mg tablet Oral use Kingdom Limited, Spafield, Cork 30mg Road, Cashel, Co. Tipperary Ireland United Ranbaxy Ireland Codeine phosphate Tablets Codeine phosphate 60mg tablet Oral use Kingdom Limited, Spafield, Cork 60mg BP Road, Cashel, Co. Tipperary Ireland United Aspar Pharmaceuticals Aspar Pharms Co-codamol Codeine phosphate + 8mg + 500mg tablet Oral use Kingdom Limited, 29-30 Capitol Tablets 8mg/500mg paracetamol Way, Colindale, London NW9 0EQ United Kingdom

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

United Aspar Pharmaceuticals Aspar Pharms Co-codamol Codeine phosphate + 8mg + 500mg tablet Oral use Kingdom Limited, 29-30 Capitol Tablets BP 8/500mg paracetamol Way, Colindale, London NW9 0EQ United Kingdom United Tillomed Laboratories Tillomed Labs Co-codamol Codeine phosphate + 8mg + 500mg tablet Oral use Kingdom Limited, 3 Howard Tablets 8mg/500mg paracetamol Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET United Kingdom United Wrafton Laboratories Teva Dual Action Pain Relief Codeine phosphate 8mg + 30mg + capsule Oral use Kingdom Limited, Exeter Road, Capsules hemihydrate + caffeine + 500 mg Wrafton, Braunton, paracetamol Devon EX33 2DL United Kingdom United Wrafton Laboratories Wrafton Labs Co-codamol Plus Codeine phosphate 8mg + 30mg + tablet Oral use Kingdom Limited, Exeter Road, Caffeine Tablets hemihydrate + caffeine + 500 mg Wrafton, Braunton, paracetamol Devon EX33 2DL United Kingdom United Mercury Mercury Pharms Co-codamol Codeine phosphate + 30mg + 500 mg capsule Oral use Kingdom Pharmaceuticals Capsules 30mg/500mg paracetamol Limited, No. 1 Croydon, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT United Kingdom United Mercury Mercury Pharms Co-codamol Codeine phosphate + 30mg + 500 mg tablet Oral use Kingdom Pharmaceuticals Tablets 30mg/500mg paracetamol Limited, No. 1 Croydon, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 54/66

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

United Mercury Mercury Pharms Co-codamol Codeine phosphate + 15mg + 500mg Coated tablet Oral use Kingdom Pharmaceuticals Tablets 15mg/500mg paracetamol Limited, No. 1 Croydon, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT United Kingdom United Mercury Codipar effervescent tablets Codeine phosphate 15mg + 500mg effervescent Oral use Kingdom Pharmaceuticals 15mg/500mg hemihydrate + tablet Limited, No. 1 Croydon, paracetamol 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT United Kingdom United Mercury Mercury Pharms Co-codamola Codeine phosphate 30mg + 500 mg effervescent Oral use Kingdom Pharmaceuticals effervescent tablets hemihydrate + tablet Limited, No. 1 Croydon, 30mg/500mg paracetamol 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT United Kingdom United Mercury Codipar Capsules 15mg/500mg Codeine phosphate + 15mg + 500mg capsule, hard Oral use Kingdom Pharmaceuticals paracetamol Limited, No. 1 Croydon, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT United Kingdom United South Devon Codeine phsophate injection Codeine phosphate 60mg/ml Solution for Intramuscular Kingdom Healthcare NHS 60mg in 1ml injection Foundation Trust, Torbay PMU, Long Road, Paignton, Devon TQ4 7TW United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 55/66

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

United McNeil Products Warner-Lambert CH Migraleve Codeine phosphate + 8mg + 520mg + Coated tablet Oral use Kingdom Limited, Foundation Pink Tablets paracetamol + buclizine 6.25mg Park, Roxborough Way, hydrochloride Maidenhead, Berkshire SL6 3UG United Kingdom United McNeil Products Warner-Lambert CH Migraleve Codeine phosphate + 8mg + 520mg Coated tablet Oral use Kingdom Limited, Foundation Yellow Tablets paracetamol Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG United Kingdom United McNeil Products Warner-Lambert CH Migraleve Codeine phosphate + 8mg + 520mg + Coated tablet Oral use Kingdom Limited, Foundation Tablets paracetamol + buclizine 6.25mg Park, Roxborough Way, hydrochloride Maidenhead, Berkshire SL6 3UG United Kingdom United Manx Pharma Limited, Manx Pharma Co-codamol 30 Codeine phosphate 30mg + 500 mg effervescent Oral use Kingdom Taylor Group House, mg/500 mg effervescent hemihydrate + tablet Wedgnock Lane, tablets paracetamol Warwick CV34 5YA United Kingdom United Ayrton Saunders Soluble Cupanol-Co Lemon Codeine phosphate + 8mg + 500mg effervescent Oral use Kingdom Limited, 9 Arkwright Flavour paracetamol tablet Road, Astmoor Industrial Estate, Runcorn, Cheshire WA7 1NU United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 56/66

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

United Ayrton Saunders Co-codaprin Tablets Codeine phosphate + 8mg + 400mg tablet Oral use Kingdom Limited, 9 Arkwright aspirin Road, Astmoor Industrial Estate, Runcorn, Cheshire WA7 1NU United Kingdom United Winthrop Winthrop Pharms UK Co- Codeine phosphate 30mg + 500mg tablet Oral use Kingdom Pharmaceuticals UK codamol 30mg/500mg hemihydrate + Limited, One Onslow paracetamol Street, Guildford, Surrey GU1 4YS United Kingdom United Winthrop Sterwin Meds Co-codamol Codeine phosphate 30mg + 500mg effervescent oral use Kingdom Pharmaceuticals UK 30/500 effervescent tablets hemihydrate + tablet Limited, One Onslow 30mg/500mg paracetamol Street, Guildford, Surrey GU1 4YS United Kingdom United Winthrop Sterwin Meds Co-codamol Codeine phosphate + 8mg + 500mg tablet oral use Kingdom Pharmaceuticals UK 8/500 tablets paracetamol Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom United Winthrop Sterwin Meds Co-codamol Codeine phosphate + 8mg + 500mg Tablet for oral oral use Kingdom Pharmaceuticals UK 8/500 effervescent tablets paracetamol solution Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom United Winthrop Sterwin Meds Co-codamol and Codeine phosphate + 8mg + 500mg + effervescent oral use Kingdom Pharmaceuticals UK caffeine soluble tablets paracetamol + caffeine 30mg tablet Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 57/66

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

United Winthrop Co-codamol tablets 15/500mg Codeine phosphate 15mg + 500mg tablet oral use Kingdom Pharmaceuticals UK hemihydrate + Limited, One Onslow paracetamol Street, Guildford, Surrey GU1 4YS United Kingdom United Winthrop Winthrop Pharms Co-codamol Codeine phosphate 8mg + 500mg tablet oral use Kingdom Pharmaceuticals UK 8/500 tablets hemihydrate + Limited, One Onslow paracetamol Street, Guildford, Surrey GU1 4YS United Kingdom United Winthrop Winthrop Pharms Co-codamol Codeine phosphate 8mg + 500mg effervescent oral use Kingdom Pharmaceuticals UK 8/500 effervescent tablets hemihydrate + tablet Limited, One Onslow paracetamol Street, Guildford, Surrey GU1 4YS United Kingdom United SSL INTERNATIONAL SSL International Paracetamol, Codeine phosphate + 10mg + 450mg + tablet oral use Kingdom PLC (Reckitt Benckiser Codeine, Caffeine & paracetamol + 5mg + 30mg Group plc), Wescroft Doxylamine Compound doxylamine succinate + House, Wellcroft Road, caffeine Slough, Berkshire SL1 4AQ United Kingdom United SSL INTERNATIONAL Syndol Codeine phosphate + 10mg + 30 mg + Film-coated oral use Kingdom PLC (Reckitt Benckiser caffeine + paracetamol + 450mg + 5mg tablet Group plc), Wescroft doxylamine succinated House, Wellcroft Road, Slough, Berkshire SL1 4AQ United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 58/66

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

United SSL INTERNATIONAL Ibuprofen and codeine tablets Codeine phosphate 12.8mg + 200mg tablet oral use Kingdom PLC (Reckitt Benckiser 200mg/12.8mg hemihydrate + ibuprofen Group plc), Wescroft House, Wellcroft Road, Slough, Berkshire SL1 4AQ United Kingdom United Bristol Laboratories Bristol Labs Co-codamol Codeine phosphate + 8mg + 500mg tablet oral use Kingdom Limited, Unit 3, Tablets 8mg/500mg paracetamol Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom United Bristol Laboratories Bristol Labs Codeine Phosphate Codeine phosphate 15mg tablet oral use Kingdom Limited, Unit 3, Tablets 15mg Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom United Bristol Laboratories Codeine Phosphate Tablets BP Codeine phosphate 30mg tablet oral use Kingdom Limited, Unit 3, 30mg Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom United Bristol Laboratories Co-codamol Tablets Codeine phosphate + 30mg + 500mg tablet oral use Kingdom Limited, Unit 3, 30mg/500mg paracetamol Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 59/66

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

United CRESCENT PHARMA Co-codamol 500 mg/8 mg Codeine 8mg + 500mg tablet oral use Kingdom LTD, Polhampton Lane, tablets phosphate+paracetamol Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED, United Kingdom United CRESCENT PHARMA codeine phosphate tablets BP Codeine phosphate 15mg tablet oral use Kingdom LTD, Polhampton Lane, 15mg Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED, United Kingdom United CRESCENT PHARMA codeine phosphate tablets BP Codeine phosphate 30mg tablet oral use Kingdom LTD, Polhampton Lane, 30mg Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED, United Kingdom United CRESCENT PHARMA codeine phosphate tablets BP Codeine phosphate 60mg tablet oral use Kingdom LTD, Polhampton Lane, 60mg Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED, United Kingdom United CRESCENT PHARMA Co-codamol 500 mg/8 mg Codeine 8mg + 500mg tablet oral use Kingdom LTD, Polhampton Lane, tablets phosphate+paracetamol Units 3&4, Quidhampton Business units, Overton, Hampshire, RG25 3ED, United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 60/66

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

United FANNIN (UK) LIMITED, Co-codamol 500 mg/30 mg Codeine 30mg + 500mg effervescent oral use Kingdom 42-46 Booth Drive, tablets phosphate+paracetamol tablet Park Farm South, Wellingborough NN8 6GT United Kingdom United FANNIN (UK) LIMITED, Co-codamol 500 mg/8 mg Codeine 8mg + 500mg effervescent oral use Kingdom 42-46 Booth Drive, tablets phosphate+paracetamol tablet Park Farm South, Wellingborough NN* 6GT United Kingdom United FANNIN (UK) LIMITED, Co-codamol 8/500 mg tablets Codeine 8mg + 500mg effervescent oral use Kingdom 42-46 Booth Drive, phosphate+paracetamol tablet Park Farm South, Wellingborough NN* 6GT United Kingdom United FANNIN (UK) LIMITED, Paracetamol, codeine Paracetamol + codeine 500mg + 8mg + effervescent oral use Kingdom 42-46 Booth Drive, +caffeine 500mg/8mg/30mg phosphate hemihydrate+ 30mg tablet Park Farm South, soluble tablets caffeine Wellingborough NN* 6GT United Kingdom United AUROBINDO PHARMA Codeine phosphate 15 mg Codeine phosphate 15mg tablet oral use Kingdom LIMITED Ares Block, tablets Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom United AUROBINDO PHARMA Codeine phosphate 30 mg Codeine phosphate 30mg tablet oral use Kingdom LIMITED Ares Block, tablets Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 61/66

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

United AUROBINDO PHARMA Codeine phosphate 60 mg Codeine phosphate 60mg tablet oral use Kingdom LIMITED Ares Block, tablets Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom United CONSILIENT HEALTH Co-codamol 30/500 mg tablets codeine 30mg + 500mg effervescent oral use Kingdom LIMITED, 5th floor, phosphate+paracetamol tablet Beaux Lane, Mercer Street Lower, Dublin 2, Ireland United CONSILIENT HEALTH Co-codamol codeine 8mg + 500mg tablet oral use Kingdom LIMITED, 5th floor, phosphate+paracetamol Beaux Lane, Mercer Street Lower, Dublin 2, Ireland United CONSILIENT HEALTH Codeine phosphate 15 mg Codeine phosphate 15mg tablet oral use Kingdom LIMITED, 5th floor, tablets Beaux Lane, Mercer Street Lower, Dublin 2, Ireland United CONSILIENT HEALTH Codeine phosphate 30 mg Codeine phosphate 30mg tablet oral use Kingdom LIMITED, 5th floor, tablets Beaux Lane, Mercer Street Lower, Dublin 2, Ireland United CONSILIENT HEALTH Codeine phosphate 60 mg Codeine phosphate 60mg tablet oral use Kingdom LIMITED, 5th floor, tablets Beaux Lane, Mercer Street Lower, Dublin 2, Ireland

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 62/66

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

United CONSILIENT HEALTH Cupanol Co-codamol Codeine 8mg + 500mg effervescent oral use Kingdom LIMITED, 5th floor, phosphate+paracetamol tablet Beaux Lane, Mercer Street Lower, Dublin 2, Ireland United Galen Limited, Seogoe Co-codamol 30MG/500MG Codeine 30mg + 500mg tablet oral use Kingdom Industiral Estate, phosphate+paracetamol Craigavon BT 63 5 UA, United Kingdom United Galen Limited, Seogoe Co-codamol 30MG/500MG Codeine phosphate 30mg + 500mg capsule, hard oral use Kingdom Industiral Estate, hemihydrate+paracetam Craigavon BT 63 5 UA, ol United Kingdom United Galen Limited, Seogoe Kapake 15mg/500mg Codeine phosphate 15mg + 500mg tablet oral use Kingdom Industiral Estate, hemihydrate+paracetam Craigavon BT 63 5 UA, ol United Kingdom United WOCKHARDT UK Co-codamol 8MG/500MG Codeine 8mg + 500mg tablet oral use Kingdom LIMITED Ash Road phosphate+paracetamol North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom United WOCKHARDT UK Co-codamol 30MG/500MG Codeine 30mg + 500mg tablet oral use Kingdom LIMITED Ash Road phosphate+paracetamol North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom United WOCKHARDT UK Codeine phosphate 15 mg Codeine phosphate 15mg tablet oral use Kingdom LIMITED Ash Road tablets North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 63/66

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

United WOCKHARDT UK Codeine phosphate 30 mg Codeine phosphate 30mg tablet oral use Kingdom LIMITED Ash Road tablets North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom United WOCKHARDT UK Codeine phosphate 60 mg Codeine phosphate 60mg tablet oral use Kingdom LIMITED Ash Road tablets North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom United WOCKHARDT UK Co-codamol 8/500 mg tablets codeine 8mg + 500mg tablet oral use Kingdom LIMITED Ash Road phosphate+paracetamol North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom United WOCKHARDT UK Co-codamol 30/500 mg tablets codeine 30mg + 500mg tablet oral use Kingdom LIMITED Ash Road phosphate+paracetamol North, Wrexhan Industrial Estate, Wrexham LL13 9UF, United Kingdom United ACTAVIS GROUP PTC Co-codamol 8/500 mg tablets codeine 8mg + 500mg tablet oral use Kingdom EHF Reykjavikurvegur phosphate+paracetamol 76-78 - 220 Hafnarfjörður Iceland United MAX REMEDIES Max Remedies Clear Dissolving Codeine 8mg +500mg + effervescent ORAL USE Kingdom LIMITED, Stoney Gate Pain Relief tablets phosphate+paracetamol 30mg tablet House, 2 Greenfield +caffeine Road, Holmfirth, West Yorkshire, HD9 2JT, United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 64/66

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

United CUSTOM HEALTHCARE, custom Healthcare co-codamol Codeine 8mg + 500mg capsule oral use Kingdom Conway street,Hove, 8/500mg capsules phosphate+paracetamol East sussex, BN3 3LW United Kingdom United CUSTOM HEALTHCARE, custom Healthcare co-codamol Codeine 8mg + 500mg capsule oral use Kingdom Conway street,Hove, 8/500mg capsules phosphate+paracetamol East sussex, BN3 3LW United Kingdom United CIPLA (EU) LIMITED, Co-codamol 8/500 mg tablets Codeine 8mg + 500mg tablet oral use Kingdom Hillbrow House, phosphate+paracetamol Hillbrow Road, Esher, Surrey, KT10 9NW United Kingdom United CIPLA (EU) LIMITED, Co-codamol 30/500 mg tablets Codeine 30mg + 500mg tablet oral use Kingdom Hillbrow House, phosphate+paracetamol Hillbrow Road, Esher, Surrey, KT10 9NW United Kingdom United CIPLA (EU) LIMITED, STD chemicals paracetamol Codeine 8mg + 500mg + soluble tablet oral use Kingdom Hillbrow House, codeine and caffeine phosphate+paracetamol 30mg Hillbrow Road, Esher, + caffeine Surrey, KT10 9NW United Kingdom United FOURRTS Co-codamol tablets BP Codeine 8mg + 500mg tablet oral use Kingdom (UK)PHARMACARE phosphate+paracetamol LIMITED, 30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ, United Kingdom United FOURRTS Co-codaprin tablets B.P. Codeine 8mg + 400mg tablet oral use Kingdom (UK)PHARMACARE phosphate+Aspirin LIMITED, 30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ, United Kingdom

Annex I - List of the medicines affected by the referral EMA/124076/2013 Page 65/66

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

United ZANZA LABORATORIES Zanza Labs holdings Co- Codeine 30mg + 500mg effervescent oral use Kingdom (HOLDINGS)LIMITED, codamol phosphate+paracetamol tablet Unit 2A Sefton Business Park, Aintree, Liverpool, L30 1RD, United Kingdom United ENNOGEN PHARMA Ennogen Pharma Co-codamol Codeine 8mg +500 mg effervescent oral use Kingdom LIMITED, Unit G4, phosphate+paracetamol tablet Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS United Kingdom

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