Embed Size (px)
Citation preview
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
31 May 2018 EMA/372722/2018 Human Medicines Evaluation Division
Annex I
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, 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 Annex I may be updated during the procedure to reflect any amended information on concerned products/MAHs.
Annex I EMA/372722/2018 Page 2/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Austria G.L. Pharma Gmbh Metagelan Metamizole Sodium Monohydrate 500mg/Ml
Oral Drops, Solution Oral Use
Austria G.L. Pharma Gmbh Metagelan Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Austria Kalceks Metamizol Kalceks Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Austria Sanofi-Aventis Gmbh Osterreich
Novalgin Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Austria Sanofi-Aventis Gmbh Osterreich
Novalgin Metamizole Sodium 500mg Tablet
Film-Coated Tablet Oral Use
Austria Sanofi-Aventis Gmbh Osterreich
Novalgin Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Belgium Sanofi Belgium Novalgine Metamizole Sodium 500mg Tablet
Film-Coated Tablet Oral Use
Belgium Sanofi Belgium Novalgine Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Belgium Sanofi Belgium Novalgine I.M./I.V. Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Bulgaria Hexal Ag Hexalgin Metamizole Sodium Monohydrate 500mg Bottle
Oral Solution Oral Use
Bulgaria Actavis Ead Proalgin Metamizole Sodium 500mg Tablet
Tablet Oral Use
Annex I EMA/372722/2018 Page 3/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Bulgaria Sopharma Ad Spasmalgon Pitofenone Hydrochloride 2mg/Ml, Fenpiverinium Bromide 0.02mg/Ml, Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use
Bulgaria Medica Ad Teмпимет Metamizole Sodium 500mg Tablet, Triacetonamine Tosilate 20mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Elantis Farma S.R.L. Алгозон Metamizole Sodium 500mg Tablet
Tablet Oral Use
Bulgaria Pharmaswiss Česká Republika S.R.O.
Амизолмет Metamizole Sodium 500mg/Ml
Solution For Injection Intravenous Use
Bulgaria Sopharma Ad Аналгин Metamizole Sodium 1000mg/2ml
Solution For Injection Intramuscular Use
Bulgaria Sopharma Ad Аналгин Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Bulgaria Sopharma Ad Аналгин Metamizole Sodium 500mg Tablet
Tablet Oral Use
Bulgaria Sopharma Ad Аналгин За Деца Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Bulgaria Sopharma Ad Аналгин Хин Metamizole Sodium 250mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Inbiotech Ltd Ангетоп Metamizole Sodium 500mg Tablet
Tablet Oral Use
Annex I EMA/372722/2018 Page 4/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Bulgaria Actavis Ead Беналгин Thiamine Hydrochloride 38.75mg Tablet, Metamizole Sodium 500mg Tablet, Caffeine 50mg Tablet
Tablet Oral Use
Bulgaria Adipharm Ead Бенлек Thiamine Hydrochloride 38.75mg Tablet, Metamizole Sodium 500mg Tablet, Caffeine 50mg Tablet
Tablet Oral Use
Bulgaria Generica Ood Генералгин Metamizole Sodium 500mg Tablet
Tablet Oral Use
Bulgaria Chemax Pharma Ltd Диалгин Metamizole Sodium Monohydrate 500mg/Ml
Oral Drops, Solution Oral Use
Bulgaria Chemax Pharma Ltd Диалгин Metamizole Sodium 1000mg Sachet
Powder For Oral Solution
Oral Use
Bulgaria Chemax Pharma Ltd Диалгин Metamizole Sodium 500mg Sachet
Powder For Oral Solution
Oral Use
Bulgaria Chemax Pharma Ltd Диалгин Джуниор Metamizole Sodium Monohydrate 250mg Sachet
Powder For Oral Solution
Oral Use
Bulgaria Chemax Pharma Ltd Диалгин Експрес Metamizole Sodium 500mg Sachet, Caffeine 50mg Sachet
Powder For Oral Solution In Sachet
Oral Use
Annex I EMA/372722/2018 Page 5/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Bulgaria Actavis Ead Невралгин Cyanocobalamin 0.5mg Tablet, Metamizole Sodium 500mg Tablet, Thiamine Nitrate 75mg Tablet, Pyridoxine Hydrochloride 50mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Unipharm Паракофдал Metamizole Sodium 300mg Tablet, Paracetamol 200mg Tablet, Caffeine 30mg Tablet, Codeine Phosphate 20mg Tablet
Tablet Oral Use
Bulgaria Actavis Ead Седалгин-Нео Metamizole Sodium 150mg Tablet, Paracetamol 300mg Tablet, Phenobarbital 15mg Tablet, Caffeine 50mg Tablet, Codeine Phosphate Hemihydrate 10mg Tablet
Tablet Oral Use
Bulgaria Actavis Ead Спазмалгон Pitofenone Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet, Metamizole Sodium 500mg Tablet
Tablet Oral Use
Annex I EMA/372722/2018 Page 6/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Bulgaria Adipharm Ead Спазмоблок Pitofenone Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet, Metamizole Sodium 500mg Tablet
Tablet Oral Use
Bulgaria Sopharma Ad Темпалгин Metamizole Sodium 500mg Tablet, Triacetonamine Tosilate 20mg Tablet
Film-Coated Tablet Oral Use
Bulgaria Adipharm Ead Фрешалгин Metamizole Sodium Monohydrate 1000mg Sachet
Effervescent Powder Oral Use
Bulgaria Adipharm Ead Фрешалгин Metamizole Sodium Monohydrate 500mg Sachet
Effervescent Powder Oral Use
Bulgaria Adipharm Ead Фрешалгин Metamizole Sodium 500mg Tablet
Tablet Oral Use
Bulgaria Sandoz Pharmaceuticals D.D.
Хексалгин За Деца Metamizole Sodium Monohydrate 500mg Bottle
Oral Solution Oral Use
Croatia Alkaloid D.O.O. Alkagin Metamizole Sodium Monohydrate 0.5g/Ml
Solution For Injection/Infusion
Intramuscular Use | Intravenous Use
Croatia Pliva Hrvatska D.O.O. Alkagin Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Annex I EMA/372722/2018 Page 7/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Croatia Pliva Hrvatska D.O.O. Analgin Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Czech Republic Zentiva, K.S. Algifen Metamizole Sodium Monohydrate 527mg Tablet, Pitofenone Hydrochloride 5.25mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Tablet Oral Use
Czech Republic Teva Czech Industries S.R.O
Algifen Neo Metamizole Sodium Monohydrate 500mg/Ml, Pitofenone Hydrochloride 5mg/25ml
Oral Drops, Solution Oral Use
Czech Republic Bb Pharma A.S. Analgin Pitofenone Hydrochloride 10mg/5ml, Fenpiverinium Bromide 0.1mg/5ml, Metamizole Sodium 2500mg/5ml
Solution For Injection Intravenous Use
Czech Republic Stada Arzneimittel Ag Metamizol Stada Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Czech Republic Stada Arzneimittel Ag Metamizol Stada Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Annex I EMA/372722/2018 Page 8/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Czech Republic Kalceks Metamizole Kalceks Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Czech Republic Sanofi-Aventis Sro Novalgin Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Czech Republic Sanofi-Aventis Sro Novalgin Metamizole Sodium Monohydrate 500mg Tablet
Film-Coated Tablet Oral Use
Finland Takeda Oy Litalgin Pitofenone Hydrochloride 2mg/Ml, Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Finland Takeda Oy Litalgin Pitofenone Hydrochloride 5mg, Metamizole Sodium 500mg
Tablet Oral Use
Finland Takeda Oy Litalgin Pitofenone Hydrochloride 10mg, Metamizole Sodium 1g
Suppository Rectal Use
Germany Medphano Arzneimittel Gmbh
Analgin Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use | Parenteral Use
Germany Medphano Arzneimittel Gmbh
Analgin Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Annex I EMA/372722/2018 Page 9/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Germany Berlin-Chemie Ag Berlosin Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Germany Berlin-Chemie Ag Berlosin Metamizole Sodium Monohydrate 1000mg Suppository
Suppository Rectal Use
Germany Berlin-Chemie Ag Berlosin Injekt Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Germany Aliud Pharma Gmbh Metamizol Al Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Germany Aristo Pharma Gmbh (Art 57)
Metamizol Aristo Metamizole Sodium Monohydrate 500mg/Ml
Oral Drops, Solution Oral Use
Germany Aristo Pharma Gmbh (Art 57)
Metamizol Aristo Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Germany Abz-Pharma Gmbh Metamizol Ct Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Germany Hexal Ag Metamizol Für Erwachsene Hexal
Metamizole Sodium Monohydrate 1000mg Suppository
Suppository Rectal Use
Germany Hameln Pharma Plus Gmbh
Metamizol Hameln Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Annex I EMA/372722/2018 Page 10/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Germany Heumann Pharma Gmbh & Co. Generica Kg
Metamizol Heumann Metamizole Sodium Monohydrate 500mg/Ml
Oral Drops, Solution Oral Use
Germany Heumann Pharma Gmbh & Co. Generica Kg
Metamizol Heumann Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Germany Hexal Ag Metamizol Hexal Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Germany Hexal Ag Metamizol Hexal Metamizole Sodium Monohydrate 500mg Tablet
Film-Coated Tablet Oral Use
Germany Hexal Ag Metamizol Hexal Metamizole Sodium Monohydrate 500mg/Ml
Oral Drops, Solution Oral Use
Germany Stada Arzneimittel Ag Metamizol Stada Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Germany Stadapharm Gmbh Metamizol Stada Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Germany Abz-Pharma Gmbh Metamizole Abz Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Germany 1 A Pharma Gmbh Metamizol-Natrium 1 H2o 1a-Pharma
Metamizole Sodium Monohydrate 500mg/Ml
Oral Solution Oral Use
Annex I EMA/372722/2018 Page 11/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Germany Sanofi-Aventis Deutschland Gmbh
Novalgin Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Germany Sanofi-Aventis Deutschland Gmbh
Novalgin Metamizole Sodium 500mg Tablet
Film-Coated Tablet Oral Use
Germany Sanofi-Aventis Deutschland Gmbh
Novalgin Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Germany Sanofi-Aventis Deutschland Gmbh
Novalgin Metamizole Sodium 50mg/Ml
Syrup Oral Use
Germany Sanofi-Aventis Deutschland Gmbh
Novalgin Fur Erwachsene
Metamizole Sodium 1g Suppository
Suppository Rectal Use
Germany Sanofi-Aventis Deutschland Gmbh
Novalgin Fur Erwachsene
Metamizole Sodium 300mg Suppository
Suppository Rectal Use
Germany Ratiopharm Gmbh Novaminsulfon Metamizole Sodium Monohydrate 1mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Germany 1 A Pharma Gmbh Novaminsulfon Metamizole 500mg/Ml Oral Solution Oral Use Germany Abz-Pharma Gmbh Novaminsulfon Metamizole Sodium
50g/50ml Oral Drops, Solution Oral Use
Germany Ratiopharm Gmbh Novaminsulfon Metamizole Sodium Monohydrate 500mg/Ml
Oral Drops, Solution Oral Use
Germany Ratiopharm Gmbh Novaminsulfon Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Germany 1 A Pharma Gmbh Novaminsulfon 1 A Pharma
Metamizole Sodium Monohydrate 500mg Tablet
Film-Coated Tablet Oral Use
Annex I EMA/372722/2018 Page 12/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Germany Hexal Ag Novaminsulfon 20 Metamizole Sodium Monohydrate 500mg/Ml
Oral Solution Oral Use
Germany Winthrop Arzneimittel Gmbh
Novaminsulfon Injekt Lichtenstein
Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Germany Winthrop Arzneimittel Gmbh
Novaminsulfon Lichtenstein
Metamizole Sodium 500mg Tablet
Film-Coated Tablet Oral Use
Germany Winthrop Arzneimittel Gmbh
Novaminsulfon Lichtenstein
Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Germany Winthrop Arzneimittel Gmbh
Novaminsulfon Lichtenstein
Metamizole Sodium 1g Suppository
Suppository Rectal Use
Germany Ratiopharm Gmbh Novaminsulfon-Ratiopharm
Metamizole Sodium Monohydrate 2.5mg/5ml
Solution For Injection Intramuscular Use | Intravenous Use
Hungary Sanofi-Aventis Zrt Algopyrin Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Hungary Sanofi-Aventis Zrt Algopyrin Metamizole Sodium 500mg Tablet
Tablet Oral Use
Hungary Elantis Farma S.R.L. Algozone Metamizole Sodium 500mg Tablet
Tablet Oral Use
Hungary Naturland Magyarország Kft.
Analgetica Fono Vii. Metamizole Sodium 450mg Tablet, Caffeine 50mg Tablet
Tablet Oral Use
Annex I EMA/372722/2018 Page 13/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Hungary Naturland Magyarország Kft.
Analgeticum Fono Vii. Metamizole Sodium 0.5g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository
Suppository Rectal Use
Hungary Naturland Magyarország Kft.
Analgeticum Forte Fono Vii.
Codeine Phosphate Sesquihydrate 0.03g Suppository, Metamizole Sodium 0.09g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository, Codeine Phosphate Hemihydrate 0.02873g Suppository
Suppository Rectal Use
Hungary Gedeon Richter Plc. Flamborin Metamizole Sodium Monohydrate 500mg/Ml
Oral Drops, Solution Oral Use
Hungary Gedeon Richter Plc. Flamborin Metamizole Sodium 500mg
Tablets Oral Use
Hungary Goodwill Pharma Ltd Metapyrin Metamizole Sodium 500mg Tablet
Film-Coated Tablet Oral Use
Hungary Aramis Pharma Kft Metarapid Metamizole Sodium 500mg Tablet
Effervescent Tablet Oral Use
Hungary Meditop Pharmaceutical Co. Ltd.
Nodoryl Metamizole Sodium Monohydrate 250mg Tablet
Tablet Oral Use
Annex I EMA/372722/2018 Page 14/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Hungary Meditop Pharmaceutical Co. Ltd.
Nodoryl Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Hungary Naturland Magyarország Kft.
Noraminophenazoni Fono Vii. Naturland
Metamizole Sodium 100mg Suppository
Suppository Rectal Use
Hungary Naturland Magyarország Kft.
Noraminophenazoni Fono Vii. Naturland
Metamizole Sodium 200mg Suppository
Suppository Rectal Use
Hungary Parma Produkt Kft Noraminophenazoni Fonovii. Parma
Metamizole Sodium 100mg Suppository
Suppository Rectal Use
Hungary Parma Produkt Kft Noraminophenazoni Fonovii. Parma
Metamizole Sodium 200mg Suppository
Suppository Rectal Use
Hungary Teva Gyógyszergyár Zrt
Optalgin Metamizole Sodium 500mg Tablet
Tablet Oral Use
Hungary Pannonpharma Kft. Panalgorin Metamizole Sodium 1g/2ml
Solution For Injection Intramuscular Use | Intravenous Use
Hungary Pannonpharma Kft. Panalgorin Metamizole Sodium 500mg Tablet
Tablet Oral Use
Hungary Sanofi-Aventis Zrt Quarelin Drotaverine Hydrochloride 40mg Tablet, Metamizole Sodium 400mg Tablet, Caffeine 60mg Tablet
Tablet Oral Use
Hungary Parma Produkt Kft Suppositorium Analgeticum Fono Vii
Metamizole Sodium 0.5g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository
Suppository Rectal Use
Annex I EMA/372722/2018 Page 15/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Hungary Hungaro-Gal Gyógyszergyártó Kft
Suppositorium Analgeticum Forte Fono Vii
Metamizole Sodium 0.9g Suppository, Caffeine 0.05g Suppository, Codeine Phosphate Hemihydrate 0.03g Suppository
Suppository Rectal Use
Hungary Parma Produkt Kft Suppositorium Analgeticum Forte Fono Vii
Codeine Phosphate Sesquihydrate 0.03g Suppository, Metamizole Sodium 0.9g Suppository, Caffeine And Sodium Benzoate 0.1g Suppository, Codeine Phosphate Hemihydrate 0.02873g Suppository
Suppository Rectal Use
Hungary Parma Produkt Kft Tabletta Analgetica Fono Vii
Metamizole Sodium 450mg Tablet, Caffeine 50mg Tablet
Tablet Oral Use
Italy Abc Farmaceutici S.P.A.
Metamizolo Sodico Abc Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Italy Sanofi S.P.A Novalgina Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Italy Sanofi S.P.A Novalgina Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Annex I EMA/372722/2018 Page 16/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Italy S.F. Group Srl Novazol Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Italy So.Se.Pharm S.R.L. Piralgin Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Latvia Briz Ltd Analgin Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Latvia Briz Ltd Analgin Metamizole Sodium 500mg Tablet
Tablet Oral Use
Latvia Kalceks Metamizole Sodium Kalceks
Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Latvia Briz Ltd Spasmalgon Pitofenone Hydrochloride 2mg/Ml, Fenpiverinium Bromide 0.02mg/Ml, Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use
Latvia Actavis Nordic A/S Spasmalgon Pitofenone Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet, Metamizole Sodium 500mg Tablet
Tablet Oral Use
Latvia Briz Ltd Tempalgin Metamizole Sodium 500mg Tablet, Triacetonamine Tosilate 20mg Tablet
Film-Coated Tablet Oral Use
Annex I EMA/372722/2018 Page 17/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Lithuania Sopharma Ad Analgin Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Lithuania Sopharma Ad Analgin Metamizole Sodium 500mg Tablet
Tablet Oral Use
Lithuania Sopharma Ad Analgin Sopharma Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Lithuania Sopharma Ad Analgin Sopharma Metamizole Sodium 500mg Tablet
Tablet Oral Use
Lithuania Pharmaswiss Česká Republika S.R.O.
Analginas Metamizole Sodium 1g/2ml
Solution For Injection Intramuscular Use | Intravenous Use
Lithuania Pharmaswiss Česká Republika S.R.O.
Analginas Metamizole Sodium 500mg Tablet
Tablet Oral Use
Lithuania Kalceks Metamizole Sodium Kalceks
Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Luxembourg Sanofi Belgium Novalgin Metamizole Sodium 500mg Tablet
Film-Coated Tablet Oral Use
Luxembourg Sanofi Belgium Novalgin Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Luxembourg Sanofi Belgium Novalgine Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Netherlands Will Pharma B.V. Metamizol Will-Pharma Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Annex I EMA/372722/2018 Page 18/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Poland Adamed Consumer Healthcare S.A.
Gardan Metamizole Sodium 500mg Tablet
Tablet Oral Use
Poland Fresenius Kabi Polska Sp. Z O.O.
Metamizole Kabi Metamizole Sodium 1000mg
Solution For Injection Intramuscular Use | Intravenous Use
Poland Kalceks Metamizole Kalceks Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Pyralgin Metamizole Sodium 1g/2ml
Solution For Injection Intramuscular Use | Intravenous Use
Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Pyralgina Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Poland Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna
Pyralgina Gorączka Metamizole Magnesium 500mg Sachet
Granules For Oral Solution
Oral Use
Poland Wrocławskie Zakłady Zielarskie "herbapol" S.A.
Scopolan Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg Tablet
Coated Tablet Oral Use
Annex I EMA/372722/2018 Page 19/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Poland Sopharma Warszawa Sp. Z O.O.
Spasmalgon Pitofenone Hydrochloride 2mg/Ml, Fenpiverinium Bromide 0.02mg/Ml, Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use
Portugal Sidefarma - Sociedade Industrial De Expansão Farmacêutica, S.A.
Dolocalma Metamizole Magnesium 575mg Capsule
Capsule Oral Use
Portugal Sidefarma - Sociedade Industrial De Expansão Farmacêutica, S.A.
Dolocalma Metamizole Magnesium Hexahydrate 575mg Capsule
Capsule, Hard Oral Use
Portugal Cinfa Portugal, Lda. Metamizol Cinfa Metamizole Magnesium 575mg Capsule
Capsule, Hard Oral Use
Portugal Boehringer Ingelheim, Unipessoal, Lda.
Nolotil Metamizole Magnesium 2000mg/5ml
Solution For Injection Intramuscular Use | Intravenous Use
Portugal Boehringer Ingelheim, Unipessoal, Lda.
Nolotil Metamizole Magnesium 575mg Capsule
Capsule Oral Use
Romania S.C. Zentiva S.A. Algifen Metamizole Sodium Monohydrate 0.5g/Ml, Pitofenone Hydrochloride 2mg/Ml, Fenpiverinium Bromide 0.02mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Annex I EMA/372722/2018 Page 20/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Romania S.C. Zentiva S.A. Algifen Metamizole Sodium Monohydrate 500mg Tablet, Pitofenone Hydrochloride 5mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Tablet Oral Use
Romania S C Biofarm S A Algoblock Metamizole Sodium 500mg Tablet
Tablet Oral Use
Romania S.C. Zentiva S.A. Algocalmin Metamizole Sodium Monohydrate 0.525g/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Romania S.C. Zentiva S.A. Algocalmin Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Romania Labormed Pharma S.A. Algozone Metamizole Sodium 500mg Tablet
Tablet Oral Use
Romania Laropharm Srl Alindor Metamizole Sodium 500mg Tablet
Tablet Oral Use
Romania Torrent Pharma Srl Alvotor Metamizole Sodium Monohydrate 25mg Drop
Oral Drops, Solution Oral Use
Romania Torrent Pharma Srl Alvotor Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Romania Sc Centrofarm Sa Centralgin Metamizole Sodium 500mg Tablet
Tablet Oral Use
Annex I EMA/372722/2018 Page 21/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Romania Stada Arzneimittel Ag Locamin Metamizole Sodium 474.4mg/Ml
Oral Drops, Solution Oral Use
Romania Farmacom Sa Metamizol Metamizole Sodium 500mg Tablet
Tablet Oral Use
Romania S.C.Sintofarm.S.A. Metamizol Sintocalmin Metamizole 500mg Tablet
Melting Tablets Oral Use
Romania Antibiotice Sa Novocalmin Metamizole Sodium 500mg Tablet
Tablet Oral Use
Romania Antibiotice Sa Novocalmin Metamizole Sodium 300mg Suppository
Suppository Rectal Use
Romania Antibiotice Sa Piafen Pitofenone Hydrochloride 5mg Tablet, Metamizole Sodium 500mg Tablet, Fenpipramide Bromomethylate 0.1mg Tablet
Tablet Oral Use
Romania Sanofi Romania Srl Quarelin Drotaverine Hydrochloride 40mg Tablet, Metamizole Sodium 400mg Tablet, Caffeine 60mg Tablet
Tablet Oral Use
Annex I EMA/372722/2018 Page 22/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Slovakia Zentiva, K.S. Algifen Metamizole Sodium Monohydrate 527mg Tablet, Pitofenone Hydrochloride 5.25mg Tablet, Fenpiverinium Bromide 0.1mg Tablet
Tablet Oral Use
Slovakia Teva Czech Industries S.R.O
Algifen Neo Pitofenone Hydrochloride 5mg/Ml, Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Slovakia Bb Pharma A.S. Analgin Metamizole Sodium Monohydrate 2500mg/5ml, Pitofenone Hydrochloride 10mg/5ml, Fenpiverinium Bromide 0.1mg/5ml
Solution For Injection Intramuscular Use | Intravenous Use
Slovakia G.L. Pharma Gmbh Metamilan Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Slovakia Stada Arzneimittel Ag Metamistad Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Slovakia Stada Arzneimittel Ag Metamizol Stada Metamizole Sodium Monohydrate 500mg/Ml
Oral Drops, Solution Oral Use
Annex I EMA/372722/2018 Page 23/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Slovakia Kalceks Metamizole Kalceks Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Slovakia Sanofi-Aventis Slovakia Sro
Novalgin Metamizole Sodium 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Slovakia Sanofi-Aventis Slovakia Sro
Novalgin Metamizole Sodium 500mg Tablet
Film-Coated Tablet Oral Use
Slovakia Sanofi-Aventis Slovakia Sro
Quarelin Drotaverine Hydrochloride 40mg Tablet, Metamizole Sodium 400mg Tablet, Caffeine 60mg Tablet
Tablet Oral Use
Slovenia Alkaloid-Int D.O.O. Analgin Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Slovenia Alkaloid-Int D.O.O. Analgin Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Slovenia Stada Arzneimittel Ag Metamizol Stada Metamizole Sodium 474.4mg/Ml
Oral Drops, Solution Oral Use
Slovenia Stada Arzneimittel Ag Metamizol Stada Metamizole Sodium Monohydrate 500mg/Ml
Oral Drops, Solution Oral Use
Slovenia Stada Arzneimittel Ag Metamizol Stada Metamizole Sodium Monohydrate 500mg Tablet
Tablet Oral Use
Annex I EMA/372722/2018 Page 24/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Slovenia Kalceks Natrijev Metamizolat Kalceks
Metamizole Sodium Monohydrate 500mg/Ml
Solution For Injection Intramuscular Use | Intravenous Use
Spain Mabo-Farma, S.A. Algi-Mabo Metamizole Magnesium 2000mg Ampoule
Solution For Injection Intramuscular Use | Intravenous Use
Spain Mabo-Farma, S.A. Algi-Mabo Metamizole Magnesium 500mg Capsule
Capsule, Hard Oral Use
Spain Mabo-Farma, S.A. Algi-Mabo Adultos Metamizole Magnesium 1000mg Suppository
Suppository Rectal Use
Spain Sanofi-Aventis, S.A. Buscapina Compositum Metamizole Sodium 2.5g/5ml, Hyoscine Butylbromide 0.02g/5ml
Solution For Injection Intramuscular Use | Intravenous Use
Spain Sanofi-Aventis, S.A. Buscapina Compositum Metamizole Sodium 250mg Tablet, Hyoscine Butylbromide 10mg Tablet
Coated Tablet Oral Use
Spain Laboratorios Ern, S.A. Metalgial Metamizole Sodium 500mg/Ml
Oral Drops, Solution Oral Use
Spain Laboratorios Alter, S.A. Metamizol Alter Metamizole Magnesium 575mgg
Capsule, Hard Oral Use
Spain Aristo Pharma Iberia, S.L.
Metamizol Aristo Metamizole Magnesium 575mg Capsule
Capsule, Hard Oral Use
Spain Laboratorios Cinfa, S.A.
Metamizol Cinfa Metamizole 575mg Capsule
Capsule, Hard Oral Use
Spain Kern Pharma, S.L. Metamizol Kern Pharma
Metamizole Magnesium 575mg Capsule
Capsule, Hard Oral Use
Annex I EMA/372722/2018 Page 25/25
Member State in EEA Marketing authorisaton holder
Invented name INN + Strength Pharmaceutical form Route of administration
Spain Laboratorios Normon, S.A.
Metamizol Normon Metamizole Magnesium 2g/5ml
Solution For Injection Intramuscular Use | Intravenous Use
Spain Laboratorios Normon, S.A.
Metamizol Normon Metamizole Magnesium 575mg Capsule
Capsule Oral Use
Spain Pensa Pharma, S.A.U. Metamizol Pensa Metamizole 575mg Capsule
Capsule, Hard Oral Use
Spain Ratiopharm España S.A.
Metamizol Ratiopharm Metamizole Magnesium 575mg Capsule
Capsule Oral Use
Spain Laboratorio Stada, S.L. Metamizol Stada Metamizole Magnesium 575mg Capsule
Capsule, Hard Oral Use
Spain Tarbis Farma, S.L. Metamizol Tarbis Metamizole Magnesium 575mg Tablet
Capsule, Hard Oral
Spain Teva Pharma S.L.U. Metamizol Teva Metamizole Magnesium 575mg Capsule
Capsule, Hard Oral Use
Spain Boehringer Ingelheim Espana S.A.
Nolotil Metamizole Magnesium 2g/5ml
Solution For Injection Intramuscular Use | Intravenous Use
Spain Boehringer Ingelheim Espana S.A.
Nolotil Metamizole Magnesium 575mg Capsule
Capsule, Hard Oral Use
![Leucopenia associated with metamizole: a case-control study · A number of studies have characterised cases of metamizole-induced white blood cell disorders [4– 6]; however as far](https://img.pdfslide.us/doc/110x75/5ed76cb32a2f0d6edb31f078/leucopenia-associated-with-metamizole-a-case-control-study-a-number-of-studies.jpg)
