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Codeine Art 31

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Codeine Art 31 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
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