Referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data
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1 31 May 2018 EMA/372722/2018 Human Medicines Evaluation Division List of the names, pharmaceutical forms, strengths of the medicinal products, routes of, marketing authorisation holders in the member states for metamizole containing medicinal products Referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data Procedure number: EMEA/H/A-31/1469 Please note that this draft may be updated during the procedure to reflect any amended information on concerned products/mahs. 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 Austria G.L. Pharma Gmbh Metagelan Austria G.L. Pharma Gmbh Metagelan 500mg Austria Kalceks Metamizol Kalceks Austria Sanofi-Aventis Gmbh Novalgin Osterreich Austria Sanofi-Aventis Gmbh Novalgin Osterreich 500mg Austria Sanofi-Aventis Gmbh Novalgin Osterreich Belgium Sanofi Belgium Novalgine 500mg Belgium Sanofi Belgium Novalgine Belgium Sanofi Belgium Novalgine I.M./I.V. Bulgaria Hexal Ag Hexalgin 500mg Bottle Bulgaria Actavis Ead Proalgin 500mg Oral Drops, Solution Film-Coated Oral Drops, Solution Film-Coated Oral Drops, Solution Oral Solution EMA/372722/2018 Page 2/25
3 Bulgaria Sopharma Ad Spasmalgon Pitofenone Hydrochloride 2mg/Ml, Fenpiverinium Bromide 0.02mg/Ml, Metamizole Sodium Bulgaria Medica Ad Teмпимет 500mg, Triacetonamine Tosilate 20mg Bulgaria Elantis Farma S.R.L. Алгозон 500mg Bulgaria Pharmaswiss Česká Амизолмет Republika S.R.O. Bulgaria Sopharma Ad Аналгин 1000mg/2ml Bulgaria Sopharma Ad Аналгин Bulgaria Sopharma Ad Аналгин 500mg Bulgaria Sopharma Ad Аналгин За Деца Bulgaria Sopharma Ad Аналгин Хин 250mg Bulgaria Inbiotech Ltd Ангетоп 500mg Solution For Injection Film-Coated Solution For Injection Solution For Injection Oral Drops, Solution Oral Drops, Solution Film-Coated Intramuscular Use Intramuscular Use EMA/372722/2018 Page 3/25
4 Bulgaria Actavis Ead Беналгин Thiamine Hydrochloride 38.75mg, 500mg, Caffeine 50mg Bulgaria Adipharm Ead Бенлек Thiamine Hydrochloride 38.75mg, 500mg, Caffeine 50mg Bulgaria Generica Ood Генералгин 500mg Bulgaria Chemax Pharma Ltd Диалгин Bulgaria Chemax Pharma Ltd Диалгин 1000mg Sachet Bulgaria Chemax Pharma Ltd Диалгин 500mg Sachet Bulgaria Chemax Pharma Ltd Диалгин Джуниор 250mg Sachet Bulgaria Chemax Pharma Ltd Диалгин Експрес 500mg Sachet, Caffeine 50mg Sachet Oral Drops, Solution Powder For Oral Solution Powder For Oral Solution Powder For Oral Solution Powder For Oral Solution In Sachet EMA/372722/2018 Page 4/25
5 Bulgaria Actavis Ead Невралгин Cyanocobalamin 0.5mg, Metamizole Sodium 500mg, Thiamine Nitrate 75mg, Pyridoxine Hydrochloride 50mg Bulgaria Unipharm Паракофдал 300mg, Paracetamol 200mg, Caffeine 30mg, Codeine Phosphate 20mg Bulgaria Actavis Ead Седалгин-Нео 150mg, Paracetamol 300mg, Phenobarbital 15mg, Caffeine 50mg, Codeine Phosphate Hemihydrate 10mg Bulgaria Actavis Ead Спазмалгон Pitofenone Hydrochloride 5mg, Fenpiverinium Bromide 0.1mg, 500mg Film-Coated EMA/372722/2018 Page 5/25
6 Bulgaria Adipharm Ead Спазмоблок Pitofenone Hydrochloride 5mg, Fenpiverinium Bromide 0.1mg, 500mg Bulgaria Sopharma Ad Темпалгин 500mg, Triacetonamine Tosilate 20mg Bulgaria Adipharm Ead Фрешалгин 1000mg Sachet Bulgaria Adipharm Ead Фрешалгин 500mg Sachet Bulgaria Adipharm Ead Фрешалгин 500mg Bulgaria Sandoz Хексалгин За Деца Pharmaceuticals D.D. 500mg Bottle Croatia Alkaloid D.O.O. Alkagin 0.5g/Ml Croatia Pliva Hrvatska D.O.O. Alkagin 500mg Film-Coated Effervescent Powder Effervescent Powder Oral Solution Solution For Injection/Infusion Intramuscular Use EMA/372722/2018 Page 6/25
7 Croatia Pliva Hrvatska D.O.O. Analgin 500mg Czech Republic Zentiva, K.S. Algifen 527mg, Pitofenone Hydrochloride 5.25mg, Fenpiverinium Bromide 0.1mg Czech Republic Teva Czech Industries Algifen Neo S.R.O, Pitofenone Hydrochloride 5mg/25ml Czech Republic Bb Pharma A.S. Analgin Pitofenone Hydrochloride 10mg/5ml, Fenpiverinium Bromide 0.1mg/5ml, 2500mg/5ml Czech Republic Stada Arzneimittel Ag Metamizol Stada Czech Republic Stada Arzneimittel Ag Metamizol Stada 500mg Oral Drops, Solution Solution For Injection Oral Drops, Solution EMA/372722/2018 Page 7/25
8 Czech Republic Kalceks Metamizole Kalceks Czech Republic Sanofi-Aventis Sro Novalgin Czech Republic Sanofi-Aventis Sro Novalgin 500mg Finland Takeda Oy Litalgin Pitofenone Hydrochloride 2mg/Ml, Finland Takeda Oy Litalgin Pitofenone Hydrochloride 5mg, 500mg Finland Takeda Oy Litalgin Pitofenone Hydrochloride 10mg, 1g Medphano Arzneimittel Analgin Gmbh Medphano Arzneimittel Analgin Gmbh 500mg Film-Coated Parenteral Use EMA/372722/2018 Page 8/25
9 Berlin-Chemie Ag Berlosin 500mg Berlin-Chemie Ag Berlosin 1000mg Berlin-Chemie Ag Berlosin Injekt Aliud Pharma Gmbh Metamizol Al Aristo Pharma Gmbh Metamizol Aristo (Art 57) Aristo Pharma Gmbh Metamizol Aristo (Art 57) 500mg Abz-Pharma Gmbh Metamizol Ct 500mg Hexal Ag Metamizol Für Erwachsene Hexal 1000mg Hameln Pharma Plus Metamizol Hameln Gmbh Oral Drops, Solution Oral Drops, Solution EMA/372722/2018 Page 9/25
10 Heumann Pharma Gmbh & Co. Generica Kg Metamizol Heumann Heumann Pharma Metamizol Heumann Gmbh & Co. Generica 500mg Kg Hexal Ag Metamizol Hexal Hexal Ag Metamizol Hexal 500mg Hexal Ag Metamizol Hexal Stada Arzneimittel Ag Metamizol Stada 500mg Stadapharm Gmbh Metamizol Stada Abz-Pharma Gmbh Metamizole Abz 500mg 1 A Pharma Gmbh Metamizol-Natrium 1 H2o 1a-Pharma Oral Drops, Solution Film-Coated Oral Drops, Solution Oral Drops, Solution Oral Solution EMA/372722/2018 Page 10/25
11 Sanofi-Aventis Deutschland Gmbh Novalgin Sanofi-Aventis Novalgin Film-Coated Deutschland Gmbh 500mg Sanofi-Aventis Novalgin Oral Drops, Solution Deutschland Gmbh Sanofi-Aventis Novalgin Syrup Deutschland Gmbh 50mg/Ml Sanofi-Aventis Novalgin Fur 1g Deutschland Gmbh Erwachsene Sanofi-Aventis Novalgin Fur Deutschland Gmbh Erwachsene 300mg Ratiopharm Gmbh Novaminsulfon 1mg/Ml 1 A Pharma Gmbh Novaminsulfon Metamizole Oral Solution Abz-Pharma Gmbh Novaminsulfon Oral Drops, Solution 50g/50ml Ratiopharm Gmbh Novaminsulfon Oral Drops, Solution Ratiopharm Gmbh Novaminsulfon 500mg 1 A Pharma Gmbh Novaminsulfon 1 A Pharma 500mg Film-Coated EMA/372722/2018 Page 11/25
12 Hexal Ag Novaminsulfon 20 Winthrop Arzneimittel Novaminsulfon Injekt Gmbh Lichtenstein Winthrop Arzneimittel Novaminsulfon Gmbh Lichtenstein 500mg Winthrop Arzneimittel Novaminsulfon Gmbh Lichtenstein Winthrop Arzneimittel Novaminsulfon 1g Gmbh Lichtenstein Ratiopharm Gmbh Novaminsulfon- Ratiopharm 2.5mg/5ml Hungary Sanofi-Aventis Zrt Algopyrin Hungary Sanofi-Aventis Zrt Algopyrin 500mg Hungary Elantis Farma S.R.L. Algozone 500mg Hungary Naturland Analgetica Fono Vii. Magyarország Kft. 450mg, Caffeine 50mg Oral Solution Film-Coated Oral Drops, Solution EMA/372722/2018 Page 12/25
13 Hungary Naturland Magyarország Kft. Analgeticum Fono Vii. 0.5g, Caffeine And Sodium Benzoate 0.1g Hungary Naturland Analgeticum Forte Codeine Phosphate Magyarország Kft. Fono Vii. Sesquihydrate 0.03g, 0.09g, Caffeine And Sodium Benzoate 0.1g, Codeine Phosphate Hemihydrate g Hungary Gedeon Richter Plc. Flamborin Hungary Gedeon Richter Plc. Flamborin 500mg Hungary Goodwill Pharma Ltd Metapyrin 500mg Hungary Aramis Pharma Kft Metarapid 500mg Hungary Meditop Nodoryl Pharmaceutical Co. 250mg Ltd. Oral Drops, Solution s Film-Coated Effervescent EMA/372722/2018 Page 13/25
14 Hungary Meditop Pharmaceutical Co. Ltd. Nodoryl 500mg Hungary Naturland Noraminophenazoni Magyarország Kft. Fono Vii. Naturland 100mg Hungary Naturland Noraminophenazoni Magyarország Kft. Fono Vii. Naturland 200mg Hungary Parma Produkt Kft Noraminophenazoni Fonovii. Parma 100mg Hungary Parma Produkt Kft Noraminophenazoni Fonovii. Parma 200mg Hungary Teva Gyógyszergyár Optalgin Zrt 500mg Hungary Pannonpharma Kft. Panalgorin 1g/2ml Hungary Pannonpharma Kft. Panalgorin 500mg Hungary Sanofi-Aventis Zrt Quarelin Drotaverine Hydrochloride 40mg, Metamizole Sodium 400mg, Caffeine 60mg Hungary Parma Produkt Kft Suppositorium Analgeticum Fono Vii 0.5g, Caffeine And Sodium Benzoate 0.1g EMA/372722/2018 Page 14/25
15 Hungary Hungaro-Gal Gyógyszergyártó Kft Suppositorium Analgeticum Forte Fono Vii 0.9g, Caffeine 0.05g, Codeine Phosphate Hemihydrate 0.03g Hungary Parma Produkt Kft Suppositorium Codeine Phosphate Analgeticum Forte Sesquihydrate 0.03g Fono Vii, 0.9g, Caffeine And Sodium Benzoate 0.1g, Codeine Phosphate Hemihydrate g Hungary Parma Produkt Kft ta Analgetica Fono Vii 450mg, Caffeine 50mg Italy Abc Farmaceutici Metamizolo Sodico Abc S.P.A. Italy Sanofi S.P.A Novalgina Italy Sanofi S.P.A Novalgina Oral Drops, Solution Oral Drops, Solution EMA/372722/2018 Page 15/25
16 Italy S.F. Group Srl Novazol Italy So.Se.Pharm S.R.L. Piralgin Latvia Briz Ltd Analgin Latvia Briz Ltd Analgin 500mg Latvia Kalceks Kalceks Latvia Briz Ltd Spasmalgon Pitofenone Hydrochloride 2mg/Ml, Fenpiverinium Bromide 0.02mg/Ml, Metamizole Sodium Latvia Actavis Nordic A/S Spasmalgon Pitofenone Hydrochloride 5mg, Fenpiverinium Bromide 0.1mg, 500mg Latvia Briz Ltd Tempalgin 500mg, Triacetonamine Tosilate 20mg Oral Drops, Solution Oral Drops, Solution Solution For Injection Intramuscular Use Film-Coated EMA/372722/2018 Page 16/25
17 Lithuania Sopharma Ad Analgin Lithuania Sopharma Ad Analgin 500mg Lithuania Sopharma Ad Analgin Sopharma Lithuania Sopharma Ad Analgin Sopharma 500mg Lithuania Pharmaswiss Česká Analginas Republika S.R.O. 1g/2ml Lithuania Pharmaswiss Česká Analginas Republika S.R.O. 500mg Lithuania Kalceks Kalceks Luxembourg Sanofi Belgium Novalgin 500mg Luxembourg Sanofi Belgium Novalgin Luxembourg Sanofi Belgium Novalgine Netherlands Will Pharma B.V. Metamizol Will-Pharma Film-Coated Oral Drops, Solution EMA/372722/2018 Page 17/25
18 Poland Adamed Consumer Healthcare S.A. Gardan 500mg Poland Fresenius Kabi Polska Metamizole Kabi Sp. Z O.O. 1000mg Poland Kalceks Metamizole Kalceks Poland Zaklady Pyralgin Farmaceutyczne 1g/2ml "polpharma" Spolka Akcyjna Poland Zaklady Pyralgina Farmaceutyczne 500mg "polpharma" Spolka Akcyjna Poland Zaklady Pyralgina Gorączka Metamizole Magnesium Farmaceutyczne 500mg Sachet "polpharma" Spolka Akcyjna Poland Wrocławskie Zakłady Scopolan Compositum Zielarskie "herbapol" 250mg, S.A. Hyoscine Butylbromide 10mg Granules For Oral Solution Coated EMA/372722/2018 Page 18/25
19 Poland Sopharma Warszawa Sp. Z O.O. Spasmalgon Pitofenone Hydrochloride 2mg/Ml, Fenpiverinium Bromide 0.02mg/Ml, Metamizole Sodium Portugal Sidefarma - Sociedade Dolocalma Metamizole Magnesium Industrial De Expansão 575mg Capsule Farmacêutica, S.A. Portugal Sidefarma - Sociedade Dolocalma Metamizole Magnesium Industrial De Expansão Hexahydrate 575mg Farmacêutica, S.A. Capsule Portugal Cinfa Portugal, Lda. Metamizol Cinfa Metamizole Magnesium 575mg Capsule Portugal Boehringer Ingelheim, Unipessoal, Lda. Nolotil Metamizole Magnesium 2000mg/5ml Portugal Boehringer Ingelheim, Nolotil Metamizole Magnesium Unipessoal, Lda. 575mg Capsule Romania S.C. Zentiva S.A. Algifen 0.5g/Ml, Pitofenone Hydrochloride 2mg/Ml, Fenpiverinium Bromide 0.02mg/Ml Solution For Injection Intramuscular Use Capsule Capsule, Hard Capsule, Hard Capsule EMA/372722/2018 Page 19/25
20 Romania S.C. Zentiva S.A. Algifen 500mg, Pitofenone Hydrochloride 5mg, Fenpiverinium Bromide 0.1mg Romania S C Biofarm S A Algoblock 500mg Romania S.C. Zentiva S.A. Algocalmin 0.525g/Ml Romania S.C. Zentiva S.A. Algocalmin 500mg Romania Labormed Pharma S.A. Algozone 500mg Romania Laropharm Srl Alindor 500mg Romania Torrent Pharma Srl Alvotor 25mg Drop Romania Torrent Pharma Srl Alvotor 500mg Romania Sc Centrofarm Sa Centralgin 500mg Oral Drops, Solution EMA/372722/2018 Page 20/25
21 Romania Stada Arzneimittel Ag Locamin 474.4mg/Ml Romania Farmacom Sa Metamizol 500mg Romania S.C.Sintofarm.S.A. Metamizol Sintocalmin Metamizole 500mg Romania Antibiotice Sa Novocalmin 500mg Romania Antibiotice Sa Novocalmin 300mg Romania Antibiotice Sa Piafen Pitofenone Hydrochloride 5mg, Metamizole Sodium 500mg, Fenpipramide Bromomethylate 0.1mg Romania Sanofi Romania Srl Quarelin Drotaverine Hydrochloride 40mg, Metamizole Sodium 400mg, Caffeine 60mg Oral Drops, Solution Melting s EMA/372722/2018 Page 21/25
22 Slovakia Zentiva, K.S. Algifen 527mg, Pitofenone Hydrochloride 5.25mg, Fenpiverinium Bromide 0.1mg Slovakia Teva Czech Industries Algifen Neo Pitofenone S.R.O Hydrochloride 5mg/Ml, Slovakia Bb Pharma A.S. Analgin 2500mg/5ml, Pitofenone Hydrochloride 10mg/5ml, Fenpiverinium Bromide 0.1mg/5ml Slovakia G.L. Pharma Gmbh Metamilan 500mg Slovakia Stada Arzneimittel Ag Metamistad 500mg Slovakia Stada Arzneimittel Ag Metamizol Stada Oral Drops, Solution Oral Drops, Solution EMA/372722/2018 Page 22/25
23 Slovakia Kalceks Metamizole Kalceks Slovakia Sanofi-Aventis Slovakia Novalgin Sro Slovakia Sanofi-Aventis Slovakia Novalgin Sro 500mg Slovakia Sanofi-Aventis Slovakia Quarelin Drotaverine Sro Hydrochloride 40mg, Metamizole Sodium 400mg, Caffeine 60mg Slovenia Alkaloid-Int D.O.O. Analgin Slovenia Alkaloid-Int D.O.O. Analgin 500mg Slovenia Stada Arzneimittel Ag Metamizol Stada 474.4mg/Ml Slovenia Stada Arzneimittel Ag Metamizol Stada Slovenia Stada Arzneimittel Ag Metamizol Stada 500mg Film-Coated Oral Drops, Solution Oral Drops, Solution EMA/372722/2018 Page 23/25
24 Slovenia Kalceks Natrijev Metamizolat Kalceks Spain Mabo-Farma, S.A. Algi-Mabo Metamizole Magnesium 2000mg Ampoule Spain Mabo-Farma, S.A. Algi-Mabo Metamizole Magnesium 500mg Capsule Spain Mabo-Farma, S.A. Algi-Mabo Adultos Metamizole Magnesium 1000mg Spain Sanofi-Aventis, S.A. Buscapina Compositum 2.5g/5ml, Hyoscine Butylbromide 0.02g/5ml Spain Sanofi-Aventis, S.A. Buscapina Compositum 250mg, Hyoscine Butylbromide 10mg Spain Laboratorios Ern, S.A. Metalgial Spain Laboratorios Alter, S.A. Metamizol Alter Metamizole Magnesium 575mgg Spain Aristo Pharma Iberia, S.L. Metamizol Aristo Metamizole Magnesium 575mg Capsule Spain Laboratorios Cinfa, Metamizol Cinfa Metamizole 575mg S.A. Capsule Spain Kern Pharma, S.L. Metamizol Kern Metamizole Magnesium Pharma 575mg Capsule Capsule, Hard Coated Oral Drops, Solution Capsule, Hard Capsule, Hard Capsule, Hard Capsule, Hard EMA/372722/2018 Page 24/25
25 Spain Laboratorios Normon, S.A. Metamizol Normon Metamizole Magnesium 2g/5ml Spain Laboratorios Normon, Metamizol Normon Metamizole Magnesium S.A. 575mg Capsule Spain Pensa Pharma, S.A.U. Metamizol Pensa Metamizole 575mg Capsule Spain Ratiopharm España S.A. Metamizol Ratiopharm Metamizole Magnesium 575mg Capsule Spain Laboratorio Stada, S.L. Metamizol Stada Metamizole Magnesium 575mg Capsule Spain Tarbis Farma, S.L. Metamizol Tarbis Metamizole Magnesium 575mg Spain Teva Pharma S.L.U. Metamizol Teva Metamizole Magnesium 575mg Capsule Spain Boehringer Ingelheim Espana S.A. Nolotil Metamizole Magnesium 2g/5ml Spain Boehringer Ingelheim Nolotil Metamizole Magnesium Espana S.A. 575mg Capsule Capsule Capsule, Hard Capsule Capsule, Hard Capsule, Hard Oral Capsule, Hard Capsule, Hard EMA/372722/2018 Page 25/25
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List of nationally authorised medicinal products
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