Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2024 to 30 November 2024 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Date: 2024-12-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_202407476EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/7476


30.12.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2024 to 30 November 2024
         


(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
                (1)
, Article 38 of Directive 2001/82/EC
                (2)
or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council
                (3)
)


(C/2024/7476)

—   Issuing, maintenance or modification of a national marketing authorisation











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




22.11.2024


Metamizole


metamizole


See Annex


See Annex


25.11.2024






(1)  
            OJ L 311, 28.11.2001, p. 67, ELI: https://data.europa.eu/eli/dir/2001/83/oj.

(2)  
            OJ L 311, 28.11.2001, p. 1, ELI: https://data.europa.eu/eli/dir/2001/82/oj.

(3)  
            OJ L 4, 7.1.2019, p. 43, ELI: https://data.europa.eu/eli/reg/2019/6/oj.




ANNEX
List of medicinal products and presentations











Member State in EEA


Marketing authorisation holder


Product name


INN/active substance


Strength


Pharmaceutical form


Route of administration




Austria


+pharma Arzneimittel Gmbh


Metamizol +pharma


metamizole


1 000 mg


Film-coated tablet


Oral use




Austria


G.L. Pharma Gmbh


Metagelan


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Austria


G.L. Pharma Gmbh


Metagelan


metamizole


500 mg


Film-coated tablet


Oral use




Austria


G.L. Pharma Gmbh


Metagelan


metamizole


500 mg/ml


Oral drops, solution


Oral use




Austria


G.L. Pharma Gmbh


Metagelan


metamizole


500 mg


Tablet


Oral use




Austria


Genericon Pharma Gesellschaft M.B.H.


Novakut


metamizole


1 000 mg


Film-coated tablet


Oral use




Austria


Hcs Bvba


Metamizol Hcs


metamizole


500 mg/ml


Solution for injection/infusion


Intramuscular use | intravenous use




Austria


Kalceks


Metamizol Kalceks


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Austria


Opella Healthcare Austria Gmbh


Novalgin


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Austria


Opella Healthcare Austria Gmbh


Novalgin


metamizole


500 mg


Film-coated tablet


Oral use




Austria


Opella Healthcare Austria Gmbh


Novalgin


metamizole


500 mg/ml


Oral drops, solution


Oral use




Belgium


Opella Healthcare Belgium (Handelsnaam Sanofi Belgium)


Novalgine


metamizole


1 000 mg/2 ml


Solution for injection


Intramuscular use | intravenous use




Belgium


Opella Healthcare Belgium (Handelsnaam Sanofi Belgium)


Novalgine I.M./I.V.


metamizole


1 000 mg/2 ml


Solution for injection


Intramuscular use | intravenous use




Belgium


Opella Healthcare Belgium (Handelsnaam Sanofi Belgium)


Novalgine


metamizole


500 mg


Film-coated tablet


Oral use




Belgium


Opella Healthcare Belgium (Handelsnaam Sanofi Belgium)


Novalgine


metamizole


500 mg/ml


Oral drops, solution


Oral use




Bulgaria


Adipharm Ead


Аналгин Макс


metamizole


1 000 mg


Effervescent powder


Oral use




Bulgaria


Adipharm Ead


Фрешалгин


metamizole


500 mg


Effervescent powder


Oral use




Bulgaria


Adipharm Ead


Спазмоблок Д


metamizole, pitofenone


500 mg/ml, 5 mg/ml


Oral drops, solution


Oral use




Bulgaria


Adipharm Ead


Бенлек Експрес


metamizole, thiamine, caffeine


500 mg, 37,61 mg, 50 mg


Powder for oral solution


Oral use




Bulgaria


Adipharm Ead


Дро Спаз Комплекс


drotaverine, metamizole, caffeine


40 mg, 400 mg, 60 mg


Powder for oral solution in sachet


Oral use




Bulgaria


Adipharm Ead


Спазмоблок


metamizole, pitofenone


500 mg, 5 mg


Powder for oral solution in sachet


Oral use




Bulgaria


Adipharm Ead


Бенлек


thiamine, metamizole, caffeine


38,75 mg, 500 mg, 50 mg


Tablet


Oral use




Bulgaria


Adipharm Ead


Спазмоблок


pitofenone, fenpiverinium, metamizole


5 mg, 0,1 mg, 500 mg


Tablet


Oral use




Bulgaria


Adipharm Ead


Фрешалгин


metamizole


500 mg


Tablet


Oral use




Bulgaria


Bausch Health Ireland Limited


Амизолмет


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Bulgaria


Chemax Pharma Ltd


Диалгин


metamizole


500 mg/ml


Oral drops, solution


Oral use




Bulgaria


Chemax Pharma Ltd


Диалгин За Деца


metamizole


500 mg/ml


Oral drops, solution


Oral use




Bulgaria


Chemax Pharma Ltd


Диалгин


metamizole


1 000 mg


Powder for oral solution


Oral use




Bulgaria


Chemax Pharma Ltd


Диалгин


metamizole


500 mg


Powder for oral solution


Oral use




Bulgaria


Chemax Pharma Ltd


Диалгин Джуниор


metamizole


250 mg


Powder for oral solution


Oral use




Bulgaria


Chemax Pharma Ltd


Диалгин Експрес


metamizole, caffeine


500 mg, 50 mg


Powder for oral solution


Oral use




Bulgaria


Danhson-Bg


Омалгин


metamizole


500 mg/ml


Solution for injection


Intramuscular use




Bulgaria


Danhson-Bg


Спазмофарм


pitofenone, fenpiverinium, metamizole


4 mg/2 ml, 0,04 mg/2 ml, 1 000 mg/2 ml


Solution for injection


Intramuscular use




Bulgaria


Danhson-Bg


Омалгин Форте


thiamine, metamizole, caffeine


38,75 mg, 500 mg, 50 mg


Tablet


Oral use




Bulgaria


Danhson-Bg


Омалгин


metamizole


500 mg/ml


Oral drops, solution


Oral use




Bulgaria


Danhson-Bg


Мигренол


metamizole, paracetamol, phenobarbital, caffeine, codeine


150 mg, 300 mg, 15 mg, 50 mg, 10 mg


Tablet


Oral use




Bulgaria


Danhson-Bg


Омалгин


metamizole


500 mg


Tablet


Oral use




Bulgaria


Generica Ood


Генералгин


metamizole


500 mg


Tablet


Oral use




Bulgaria


Hexal Ag


Hexalgin


metamizole


500 mg


Oral solution


Oral use




Bulgaria


Inbiotech Ltd


Ангетоп


metamizole


500 mg


Tablet


Oral use




Bulgaria


Kalceks


Метамизол Калцекс


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Bulgaria


Kupro94


Меалгин


metamizole


500 mg/ml


Oral drops, solution


Oral use




Bulgaria


Sandoz Pharmaceuticals D.D.


Хексалгин За Деца


metamizole


500 mg


Oral solution


Oral use




Bulgaria


Sopharma Ad


Спазмалгон


pitofenone, fenpiverinium, metamizole


4 mg/2 ml, 0,04 mg/2 ml, 1 000 mg/2 ml


Solution for injection


Intramuscular use




Bulgaria


Sopharma Ad


Аналгин


metamizole


1 000 mg/2 ml


Solution for injection


Intramuscular use | intravenous use




Bulgaria


Sopharma Ad


Аналгин Хин


metamizole


250 mg


Film-coated tablet


Oral use




Bulgaria


Sopharma Ad


Темпалгин


metamizole, triacetonamine


500 mg,20 mg


Film-coated tablet


Oral use




Bulgaria


Sopharma Ad


Аналгин


metamizole


500 mg/ml


Oral drops, solution


Oral use




Bulgaria


Sopharma Ad


Аналгин За Деца


metamizole


500 mg/ml


Oral drops, solution


Oral use




Bulgaria


Sopharma Ad


Аналгин


metamizole


500 mg


Tablet


Oral use




Bulgaria


Sopharma Ad


Паракофдал


metamizole, paracetamol, caffeine, codeine


300 mg, 200 mg, 30 mg, 20 mg


Tablet


Oral use




Bulgaria


Teva Pharma Ead


Беналгин Рапид


metamizole, thiamine, caffeine


500 mg, 37,61 mg, 50 mg


Powder for oral solution


Oral use




Bulgaria


Teva Pharma Ead


Беналгин


thiamine, metamizole, caffeine


38,75 mg, 500 mg, 50 mg


Tablet


Oral use




Bulgaria


Teva Pharma Ead


Проалгин


metamizole


500 mg


Tablet


Oral use




Bulgaria


Teva Pharma Ead


Седалгин-Нео


metamizole, paracetamol, phenobarbital, caffeine, codeine


150 mg, 300 mg, 15 mg, 50 mg, 10 mg


Tablet


Oral use




Bulgaria


Teva Pharma Ead


Спазмалгон


pitofenone, fenpiverinium, metamizole


5 mg, 0,1 mg, 500 mg


Tablet


Oral use




Croatia


Alkaloid D.O.O.


Alkagin


metamizole


0,5 g/ml


Solution for injection/infusion


Intramuscular use | intravenous use




Croatia


Bausch Health Ireland Limited


Metamizolnatrij Hidrat Bausch Health


metamizole


500 mg


Film-coated tablet


Oral use




Croatia


Pliva Hrvatska D.O.O.


Analgin


metamizole


500 mg


Tablet


Oral use




Czech Republic


Auxilto Healthcare S.R.O.


Metamizol Auxilto


metamizole


500 mg


Film-coated tablet


Oral use




Czech Republic


Bausch Health Ireland Limited


Emitazem


metamizole


500 mg


Film-coated tablet


Oral use




Czech Republic


Bb Pharma A.S.


Analgin


pitofenone, fenpiverinium, metamizole


2 mg/ml, 0,02 mg/ml, 500 mg/ml


Solution for injection


Intravenous use




Czech Republic


Kalceks


Metamizole Kalceks


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Czech Republic


Krka, D.D., Novo Mesto


Algominal


metamizole


500 mg


Film-coated tablet


Oral use




Czech Republic


Medreg S.R.O.


Metamizol Medreg


metamizole


500 mg


Tablet


Oral use




Czech Republic


Noridem Enterprises Ltd


Metamizole Noridem


metamizole


500 mg/ml


Solution for injection/infusion


Intramuscular use | intravenous use




Czech Republic


Opella Healthcare Czech S.R.O


Novalgin


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Czech Republic


Opella Healthcare Czech S.R.O


Novalgin


metamizole


500 mg


Film-coated tablet


Oral use




Czech Republic


Stada Arzneimittel Ag


Metamizol Stada


metamizole


500 mg/ml


Oral drops, solution


Oral use




Czech Republic


Stada Arzneimittel Ag


Metamizol Stada


metamizole


500 mg


Tablet


Oral use




Czech Republic


Teva B.V


Metamizol Teva


metamizole


500 mg


Tablet


Oral use




Czech Republic


Teva Czech Industries S.R.O


Algifen Neo


metamizole, pitofenone


500 mg/ml, 5 mg/ml


Oral drops, solution


Oral use




Czech Republic


Zentiva, K.S.


Afexil


metamizole


500 mg/ml


Solution for injection


Intravenous use




Czech Republic


Zentiva, K.S.


Afexil


metamizole


500 mg


Film-coated tablet


Oral use




Czech Republic


Zentiva, K.S.


Algifen


metamizole, pitofenone, fenpiverinium


527 mg, 5,25 mg, 0,1 mg


Tablet


Oral use




Germany


1 A Pharma Gmbh


Novaminsulfon 500


metamizole


500 mg


Film-coated tablet


Oral use




Germany


1 A Pharma Gmbh


Novaminsulfon Tropfen


metamizole


500 mg/ml


Oral drops, solution


Oral use




Germany


A. Nattermann & Cie. Gmbh


Novalgin


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Germany


A. Nattermann & Cie. Gmbh


Novalgin


metamizole


500 mg


Film-coated tablet


Oral use




Germany


A. Nattermann & Cie. Gmbh


Novalgin Tropfen


metamizole


500 mg/ml


Oral drops, solution


Oral use




Germany


A. Nattermann & Cie. Gmbh


Novalgin


metamizole


50 mg/ml


Syrup


Oral use




Germany


A. Nattermann & Cie. Gmbh


Novalgin


metamizole


0,3 g


Suppository


Rectal use




Germany


A. Nattermann & Cie. Gmbh


Novalgin


metamizole


1 g


Suppository


Rectal use




Germany


A. Nattermann & Cie. Gmbh


Novalgin Für Erwachsene


metamizole


1 g


Suppository


Rectal use




Germany


A. Nattermann & Cie. Gmbh


Novalgin Für Kinder


metamizole


0,3 g


Suppository


Rectal use




Germany


Abanta Pharma Gmbh


Analgin


metamizole


500 mg


Tablet


Oral use




Germany


Abz-Pharma Gmbh


Novaminsulfon


metamizole


50 g/100 ml


Oral drops, solution


Oral use




Germany


Abz-Pharma Gmbh


Metamizole Abz


metamizole


500 mg


Tablet


Oral use




Germany


Aliud Pharma Gmbh


Metamizol Al


metamizole


500 mg/ml


Oral drops, solution


Oral use




Germany


Aristo Pharma Gmbh (Art 57)


Metamizol Aristo


metamizole


1 000 mg


Film-coated tablet


Oral use




Germany


Aristo Pharma Gmbh (Art 57)


Metamizol Aristo


metamizole


500 mg/ml


Oral drops, solution


Oral use




Germany


Aristo Pharma Gmbh (Art 57)


Metamizol Aristo


metamizole


500 mg


Tablet


Oral use




Germany


Berlin-Chemie Ag


Berlosin


metamizole


500 mg


Tablet


Oral use




Germany


Berlin-Chemie Ag


Berlosin


metamizole


1 000 mg


Suppository


Rectal use




Germany


Carinopharm Gmbh


Analgin Ampullen


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Germany


Hameln Pharma Gmbh


Metamizol Hameln


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Germany


Heumann Pharma Gmbh & Co. Generica Kg


Metamizol Heumann


metamizole


500 mg/ml


Oral drops, solution


Oral use




Germany


Heumann Pharma Gmbh & Co. Generica Kg


Metamizol Heumann


metamizole


500 mg


Tablet


Oral use




Germany


Hexal Ag


Metamizol Hexal


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Germany


Hexal Ag


Metamizol Hexal


metamizole


500 mg


Film-coated tablet


Oral use




Germany


Hexal Ag


Metamizol Hexal


metamizole


500 mg/ml


Oral solution


Oral use




Germany


Kalceks


Metamizol Kalceks


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Germany


Ratiopharm Gmbh


Novaminsulfon


metamizole


1 g/2 ml


Solution for injection


Intramuscular use | intravenous use




Germany


Ratiopharm Gmbh


Novaminsulfon-Ratiopharm


metamizole


2 500 mg/5 ml


Solution for injection


Intramuscular use | intravenous use




Germany


Ratiopharm Gmbh


Novaminsulfon


metamizole


500 mg/ml


Oral drops, solution


Oral use




Germany


Ratiopharm Gmbh


Metamizol Ratiopharm


metamizole


500 mg


Tablet


Oral use




Germany


Ratiopharm Gmbh


Novaminsulfon


metamizole


500 mg


Tablet


Oral use




Germany


Stada Arzneimittel Ag


Metamizol Stada


metamizole


500 mg


Tablet


Oral use




Germany


Stadapharm Gmbh


Metamizol Stada


metamizole


500 mg/ml


Oral drops, solution


Oral use




Germany


Tad Pharma Gmbh


Metamizol Tad


metamizole


500 mg/ml


Solution for injection/infusion


Intramuscular use | intravenous use




Germany


Winthrop Arzneimittel Gmbh


Novaminsulfon Injekt Lichtenstein


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Germany


Winthrop Arzneimittel Gmbh


Novaminsulfon Lichtenstein


metamizole


500 mg


Film-coated tablet


Oral use




Germany


Winthrop Arzneimittel Gmbh


Novaminsulfon Lichtenstein


metamizole


500 mg/ml


Oral drops, solution


Oral use




Germany


Winthrop Arzneimittel Gmbh


Novaminsulfon Lichtenstein


metamizole


1 g


Suppository


Rectal use




Germany


Zentiva Pharma Gmbh


Metamizol Zentiva


metamizole


500 mg


Film-coated tablet


Oral use




Germany


Zentiva Pharma Gmbh


Metamizol Zentiva


metamizole


500 mg/ml


Oral drops, solution


Oral use




Hungary


Gedeon Richter Plc.


Flamborin


metamizole


500 mg/ml


Oral drops, solution


Oral use




Hungary


Gedeon Richter Plc.


Flamborin


metamizole


500 mg


Tablet


Oral use




Hungary


Goodwill Pharma Nyrt.


Metapyrin


metamizole


500 mg


Film-coated tablet


Oral use




Hungary


Kalceks


Metamizole Kalceks


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Hungary


Magnapharm Hungary Kft


Algozone


metamizole


500 mg


Tablet


Oral use




Hungary


Meditop Pharmaceutical Co. Ltd.


Metamizol Meditop


metamizole


500 mg


Tablet


Oral use




Hungary


Meditop Pharmaceutical Co. Ltd.


Nodoryl


metamizole


500 mg


Tablet


Oral use




Hungary


Meditop Pharmaceutical Co. Ltd.


Nodoryl Complex


drotaverine, metamizole, caffeine


20 mg, 200 mg, 30 mg


Tablet


Oral use




Hungary


Meditop Pharmaceutical Co. Ltd.


Nodoryl Complex


drotaverine, metamizole, caffeine


40 mg, 400 mg, 60 mg


Tablet


Oral use




Hungary


Meditop Pharmaceutical Co. Ltd.


Nodoryl Dolo


metamizole


250 mg


Tablet


Oral use




Hungary


Meditop Pharmaceutical Co. Ltd.


Nodoryl Forte


metamizole


500 mg


Tablet


Oral use




Hungary


Naturland Magyarország Kft.


Analgetica Fono Viii.


metamizole, caffeine


450 mg, 50 mg


Tablet


Oral use




Hungary


Naturland Magyarország Kft.


Analgeticum Fono Vii.


metamizole, caffeine


0,5 g, 0,05 g


Suppository


Rectal use




Hungary


Naturland Magyarország Kft.


Analgeticum Forte Fono Vii.


metamizole, caffeine, codeine


0,9 g, 0,05 g, 0,02873 g


Suppository


Rectal use




Hungary


Naturland Magyarország Kft.


Noraminophenazoni Fono Vii. Naturland


metamizole


100 mg


Suppository


Rectal use




Hungary


Naturland Magyarország Kft.


Noraminophenazoni Fono Vii. Naturland


metamizole


200 mg


Suppository


Rectal use




Hungary


Noridem Enterprises Ltd


Metamizol Noridem


metamizole


500 mg/ml


Solution for injection/infusion


Intramuscular use | intravenous use




Hungary


Opella Healthcare Commercial Kft.


Algopyrin


metamizole


1 g/2 ml


Solution for injection


Intramuscular use | intravenous use




Hungary


Opella Healthcare Commercial Kft.


Algopyrin Neo


metamizole


500 mg


Film-coated tablet


Oral use




Hungary


Opella Healthcare Commercial Kft.


Algopyrin


metamizole


500 mg


Tablet


Oral use




Hungary


Opella Healthcare Commercial Kft.


Quarelin


drotaverine, metamizole, caffeine


40 mg, 400 mg, 60 mg


Tablet


Oral use




Hungary


Pannonpharma Kft.


Panalgorin


metamizole


1 g/2 ml


Solution for injection


Intramuscular use | intravenous use




Hungary


Pannonpharma Kft.


Panalgorin


metamizole


500 mg


Tablet


Oral use




Hungary


Parma Produkt Kft


Analgetica Fono Viii.


metamizole, caffeine


450 mg, 50 mg


Tablet


Oral use




Hungary


Parma Produkt Kft


Analgeticum Fono Viii


metamizole, caffeine


500 mg, 50 mg


Suppository


Rectal use




Hungary


Parma Produkt Kft


Analgeticum Forte Fono Viii


codeine, metamizole, caffeine


30 mg, 900 mg, 50 mg


Suppository


Rectal use




Hungary


Parma Produkt Kft


Metamizoli Fonoviii. Parma


metamizole


100 mg


Suppository


Rectal use




Hungary


Parma Produkt Kft


Metamizoli Fonoviii. Parma


metamizole


200 mg


Suppository


Rectal use




Hungary


Stada Arzneimittel Ag


Dolosped


metamizole


500 mg


Tablet


Oral use




Hungary


Stada Arzneimittel Ag


Metamizol Stada


metamizole


500 mg


Tablet


Oral use




Hungary


Teva Gyógyszergyár Zrt


Optalgin


metamizole


500 mg


Tablet


Oral use




Hungary


Teva Gyógyszergyár Zrt


Optalgin Neo


metamizole


500 mg


Tablet


Oral use




Hungary


Zaklady Farmaceutyczne Polpharma S.A.


Pyralgina


metamizole


1 000 mg


Film-coated tablet


Oral use




Hungary


Zentiva, K.S.


Nofebran


metamizole


500 mg


Film-coated tablet


Oral use




Italy


Abc Farmaceutici S.P.A.


Metamizolo Sodico Abc


metamizole


500 mg/ml


Oral drops, solution


Oral use




Italy


Opella Healthcare Italy S.R.L.


Novalgina


metamizole


1 g/2 ml


Solution for injection


Intramuscular use | intravenous use




Italy


Opella Healthcare Italy S.R.L.


Novalgina


metamizole


500 mg/ml


Oral drops, solution


Oral use




Italy


So.Se.Pharm S.R.L.


Piralgin


metamizole


500 mg/ml


Oral drops, solution


Oral use




Latvia


Actavis Group Ptc Ehf.


Spasmalgon


pitofenone, fenpiverinium, metamizole


5 mg, 0,1 mg, 500 mg


Tablet


Oral use




Latvia


Kalceks


Metamizole Sodium Kalceks


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Latvia


Sopharma Ad


Analgin


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Latvia


Sopharma Ad


Tempalgin


metamizole, triacetonamine


500 mg, 20 mg


Film-coated tablet


Oral use




Latvia


Sopharma Ad


Analgin


metamizole


500 mg


Tablet


Oral use




Lithuania


Bausch Health Ireland Limited


Metamizole Sodium Bausch Health


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Lithuania


Kalceks


Metamizole Sodium Kalceks


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Lithuania


Pharmaswiss Česká Republika S.R.O.


Analginas


metamizole


1 g/2 ml


Solution for injection


Intramuscular use | intravenous use




Lithuania


Pharmaswiss Česká Republika S.R.O.


Analginas


metamizole


500 mg


Tablet


Oral use




Lithuania


Sopharma Ad


Analgin


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Lithuania


Sopharma Ad


Analgin


metamizole


500 mg


Tablet


Oral use




Luxembourg


Opella Healthcare Belgium (Handelsnaam Sanofi Belgium)


Novalgine I.M./I.V.


metamizole


1 000 mg/2 ml


Solution for injection


Intramuscular use | intravenous use




Luxembourg


Opella Healthcare Belgium (Handelsnaam Sanofi Belgium)


Novalgine


metamizole


500 mg


Film-coated tablet


Oral use




Luxembourg


Opella Healthcare Belgium (Handelsnaam Sanofi Belgium)


Novalgine


metamizole


500 mg/ml


Oral drops, solution


Oral use




Netherlands


Allgen Pharmaceuticals & Generics Bv


Dolamizol


metamizole


250 mg


Tablet


Oral use




Netherlands


Allgen Pharmaceuticals & Generics Bv


Dolamizol


metamizole


500 mg


Tablet


Oral use




Netherlands


Kalceks


Metamizol Kalceks


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Poland


Adamed Pharma S.A.


Vemonis Intense


drotaverine, metamizole, caffeine


40 mg, 400 mg, 60 mg


Film-coated tablet


Oral use




Poland


Adamed Pharma S.A.


Vemonis Ultra


drotaverine, metamizole, caffeine


80 mg, 400 mg, 60 mg


Film-coated tablet


Oral use




Poland


Aristo Pharma Sp. Z O.O.


Axonalgin


metamizole


1 000 mg


Film-coated tablet


Oral use




Poland


Bausch Health Ireland Limited


Pyreoxing


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Poland


Bausch Health Ireland Limited


Pyreox


metamizole


500 mg


Film-coated tablet


Oral use




Poland


Chemax Pharma Ltd


Dialginum


metamizole


500 mg


Powder for oral solution in sachet


Oral use




Poland


Chemax Pharma Ltd


Dialginum


metamizole


1 000 mg


Powder for oral solution in sachet


Oral use




Poland


Dr. Max Pharma S.R.O.


Metamizol Dr. Max


metamizole


500 mg


Tablet


Oral use




Poland


Fresenius Kabi Polska Sp. Z O.O.


Metamizole Kabi


metamizole


1 000 mg


Solution for injection


Intramuscular use | intravenous use




Poland


Kalceks


Metamizole Kalceks


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Poland


Promedo Pharma Products Gmbh


Metamizol Promedo


metamizole


500 mg


Tablet


Oral use




Poland


Solinea Sp. Z O.O. Sp. K.


Benlek


metamizole, thiamine, caffeine


500 mg, 38,75 mg, 50 mg


Tablet


Oral use




Poland


Sopharma Warszawa Sp. Z O.O.


Spasmalgon


pitofenone, fenpiverinium, metamizole


2 mg/ml, 0,02 mg/ml, 500 mg/ml


Solution for injection


Intramuscular use




Poland


Sopharma Warszawa Sp. Z O.O.


Re-Algin


metamizole


500 mg


Tablet


Oral use




Poland


Sun-Farm Sp. Z.O.O.


Metamizol-Sf


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Poland


Sun-Farm Sp. Z.O.O.


Pyretolek


metamizole


500 mg


Film-coated tablet


Oral use




Poland


Wrocławskie Zakłady Zielarskie ‘herbapol’ S.A.


Scopolan Compositum


metamizole, hyoscine


250 mg, 10 mg


Coated tablet


Oral use




Poland


Zaklady Farmaceutyczne Polpharma S.A.


Pyralgin


metamizole


1 g/2 ml


Solution for injection


Intramuscular use | intravenous use




Poland


Zaklady Farmaceutyczne Polpharma S.A.


Pyralgina Max


metamizole


1 000 mg


Film-coated tablet


Oral use




Poland


Zaklady Farmaceutyczne Polpharma S.A.


Pyralgina Plus


drotaverine, metamizole, caffeine


40 mg, 400 mg, 60 mg


Film-coated tablet


Oral use




Poland


Zaklady Farmaceutyczne Polpharma S.A.


Pyralgina Ból I Gorączka


metamizole


500 mg


Granules for oral solution


Oral use




Poland


Zaklady Farmaceutyczne Polpharma S.A.


Pyralgin


metamizole


25 mg


Oral drops, solution


Oral use




Poland


Zaklady Farmaceutyczne Polpharma S.A.


Pyralgina


metamizole


500 mg


Tablet


Oral use




Poland


Zentiva, K.S.


Pixalzina


metamizole


500 mg


Film-coated tablet


Oral use




Portugal


Aristo Pharma Gmbh (Art 57)


Metamizol Aristo


metamizole


1 000 mg


Film-coated tablet


Oral use




Portugal


Boehringer Ingelheim Portugal, Lda.


Nolotil


metamizole


2000mg/5 ml


Solution for injection


Intramuscular use | intravenous use




Portugal


Boehringer Ingelheim Portugal, Lda.


Nolotil


metamizole


575 mg


Capsule


Oral use




Portugal


Faes Farma Portugal, S.A.


Metamizol Vitória


metamizole


575 mg


Capsule, hard


Oral use




Portugal


Laboratórios Basi – Indústria Farmacêutica, S.A.


Metamizol Basi


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Portugal


Sidefarma - Sociedade Industrial De Expansão Farmacêutica, S.A.


Dolocalma


metamizole


575 mg


Capsule, hard


Oral use




Portugal


Towa Pharmaceutical S.A.


Metamizol Magnésico Tolife


metamizole


575 mg


Capsule, hard


Oral use




Romania


Antibiotice Sa


Novocalmin


metamizole


500 mg


Tablet


Oral use




Romania


Antibiotice Sa


Piafen


pitofenone, metamizole, fenpipramide


5 mg, 500 mg, 0,1 mg


Tablet


Oral use




Romania


Antibiotice Sa


Novocalmin


metamizole


300 mg


Suppository


Rectal use




Romania


Arena Group S.A


Sintocalmin


metamizole


500 mg


Tablet


Oral use




Romania


Bioeel Manufacturing S.R.L.


Alvotor


metamizole


500 mg/ml


Oral drops, solution


Oral use




Romania


Chemax Pharma Ltd


Algostop


metamizole


1 000 mg


Powder for oral solution in sachet


Oral use




Romania


Chemax Pharma Ltd


Algostop


metamizole


500 mg


Powder for oral solution in sachet


Oral use




Romania


Farmacom Sa


Metamizol


metamizole


500 mg


Tablet


Oral use




Romania


Gemax Pharma S.R.O.


Metamizol Gemax Pharma


metamizole


500 mg


Tablet


Oral use




Romania


Kalceks


Metamizol Kalceks


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Romania


Labormed Pharma S.A.


Algozone


metamizole


500 mg


Tablet


Oral use




Romania


Laropharm Srl


Alindor


metamizole


500 mg


Tablet


Oral use




Romania


Opella Healthcare Romania Srl


Quarelin


drotaverine, metamizole, caffeine


40 mg, 400 mg, 60 mg


Tablet


Oral use




Romania


S.C. Sanosan S.R.L.


Metamizol Sodic Sanosan


metamizole


500 mg


Tablet


Oral use




Romania


S.C. Santa S.A.


Algiotop


metamizole


500 mg


Tablet


Oral use




Romania


Sc Centrofarm Sa


Centralgin


metamizole


500 mg


Tablet


Oral use




Romania


Sc Sintofarm Sa


Centralgin


metamizole


500 mg


Tablet


Oral use




Romania


Sopharma Ad


Metamizol Sodic Sopharma


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Romania


Stada Arzneimittel Ag


Locamin


metamizole


500 mg/ml


Oral drops, solution


Oral use




Romania


Tis Farmaceutic Sa


Tisalgin


metamizole


300 mg


Suppository


Rectal use




Romania


Zentiva S.A.


Algifen


metamizole, pitofenone, fenpiverinium


2,5 g/5 ml, 0,01 g/5 ml, 0 g/5 ml


Solution for injection


Intramuscular use | intravenous use




Romania


Zentiva S.A.


Algocalmin


metamizole


0,525 g/ml


Solution for injection


Intramuscular use | intravenous use




Romania


Zentiva S.A.


Algifen


metamizole, pitofenone, fenpiverinium


500 mg, 5 mg, 0,1 mg


Tablet


Oral use




Romania


Zentiva S.A.


Algocalmin


metamizole


500 mg


Tablet


Oral use




Romania


Zentiva, K.S.


Algocalmin


metamizole


500 mg


Film-coated tablet


Oral use




Romania


Zentiva, K.S.


Algocalmin


metamizole


500 mg/ml


Oral drops, solution


Oral use




Slovakia


Bausch Health Ireland Limited


Emitazem


metamizole


500 mg


Film-coated tablet


Oral use




Slovakia


Bb Pharma A.S.


Analgin Inj


metamizole, pitofenone, fenpiverinium


500 mg/ml, 2 mg/ml, 0,02 mg/ml


Solution for injection


Intramuscular use | intravenous use




Slovakia


Kalceks


Metamizole Kalceks


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Slovakia


Medreg S.R.O.


Metamizol Medreg


metamizole


500 mg


Tablet


Oral use




Slovakia


Opella Healthcare Slovakia S.R.O.


Novalgin


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Slovakia


Opella Healthcare Slovakia S.R.O.


Novalgin


metamizole


500 mg


Film-coated tablet


Oral use




Slovakia


Opella Healthcare Slovakia S.R.O.


Quarelin


drotaverine, metamizole, caffeine


40 mg, 400 mg, 60 mg


Tablet


Oral use




Slovakia


Stada Arzneimittel Ag


Metamizol Stada


metamizole


500 mg/ml


Oral drops, solution


Oral use




Slovakia


Stada Arzneimittel Ag


Metamistad


metamizole


500 mg


Tablet


Oral use




Slovakia


Teva B.V


Algifen Neo


pitofenone, metamizole


5 mg/ml, 500 mg/ml


Oral drops, solution


Oral use




Slovakia


Teva B.V


Metamizol Teva


metamizole


500 mg


Tablet


Oral use




Slovakia


Zentiva, K.S.


Nofebran


metamizole


500 mg/ml


Solution for injection


Intravenous use




Slovakia


Zentiva, K.S.


Nofebran


metamizole


500 mg


Film-coated tablet


Oral use




Slovakia


Zentiva, K.S.


Algifen


metamizole, pitofenone, fenpiverinium


500 mg, 5,25 mg, 0,1 mg


Tablet


Oral use




Slovenia


Alkaloid-Int D.O.O.


Analgin


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Slovenia


Alkaloid-Int D.O.O.


Analgin


metamizole


500 mg


Tablet


Oral use




Slovenia


Kalceks


Natrijev Metamizolat Kalceks


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Slovenia


Krka, D.D., Novo Mesto


Natrijev Metamizolat Krka


metamizole


500 mg/ml


Solution for injection/infusion


Intramuscular use | intravenous use




Slovenia


Krka, D.D., Novo Mesto


Algominal


metamizole


500 mg


Film-coated tablet


Oral use




Slovenia


Stada Arzneimittel Ag


Metamizol Stada


metamizole


500 mg/ml


Oral drops, solution


Oral use




Slovenia


Stada Arzneimittel Ag


Metamizol Stada


metamizole


500 mg


Tablet


Oral use




Spain


Ababor Pharmaceuticals, S.L.


Metamizol Ababor


metamizole


575 mg


Capsule, hard


Oral use




Spain


Aristo Pharma Gmbh (Art 57)


Turbet


metamizole


1 000 mg


Film-coated tablet


Oral use




Spain


Aristo Pharma Iberia, S.L.


Metamizol Aristo


metamizole


575 mg


Capsule, hard


Oral use




Spain


Boehringer Ingelheim Espana S.A.


Nolotil


metamizole


500 mg/ml


Solution for injection/infusion


Intramuscular use | intravenous use




Spain


Boehringer Ingelheim Espana S.A.


Nolotil


metamizole


575 mg


Capsule, hard


Oral use




Spain


Industria Química Y Farmaceútica Vir, S.A.


Metamizol Aiko Farmacéutica


metamizole


575 mg


Capsule, hard


Oral use




Spain


Industria Química Y Farmaceútica Vir, S.A.


Metamizol Vir


metamizole


575 mg


Capsule, hard


Oral use




Spain


Kalceks


Metamizol Kalceks


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Spain


Kern Pharma, S.L.


Metamizol Kern Pharma


metamizole


575 mg


Capsule, hard


Oral use




Spain


Laboratorio Stada, S.L.


Metamizol Stada


metamizole


575 mg


Capsule, hard


Oral use




Spain


Laboratorios Alter, S.A.


Metamizol Alter


metamizole


575 mg


Capsule, hard


Oral use




Spain


Laboratórios Basi – Indústria Farmacêutica, S.A.


Metamizol Basi


metamizole


500 mg/ml


Solution for injection


Intramuscular use | intravenous use




Spain


Laboratorios Cinfa S.A.


Metamizol Cinfa


metamizole


575 mg


Capsule, hard


Oral use




Spain


Laboratorios Combix, S.L.U.


Metamizol Combix


metamizole


575 mg


Capsule, hard


Oral use




Spain


Laboratorios Ern, S.A.


Metalgial


metamizole


500 mg/ml


Oral drops, solution


Oral use




Spain


Laboratorios Normon, S.A.


Metamizol Normon


metamizole


2 g/5 ml


Solution for injection/infusion


Intramuscular use | intravenous use | oral use




Spain


Laboratorios Normon, S.A.


Metamizol Normon


metamizole


575 mg


Capsule


Oral use




Spain


Laboratorios Normon, S.A.


Metamizol Normon


metamizole


500 mg/ml


Oral drops, solution


Oral use




Spain


Mabo-Farma, S.A


Algi-Mabo


metamizole


2 g


Solution for injection/infusion


Intramuscular use | intravenous use | oral use




Spain


Mabo-Farma, S.A


Algi-Mabo


metamizole


500 mg


Capsule, hard


Oral use




Spain


Mabo-Farma, S.A


Metamizol Mabo


metamizole


575 mg


Capsule, hard


Oral use




Spain


Opella Healthcare Spain, S.L


Buscopresc Compositum


metamizole, hyoscine


2,5 g/5 ml, 0,02 g/5 ml


Solution for injection


Intramuscular use | intravenous use




Spain


Tarbis Farma, S.L.


Metamizol Tarbis


metamizole


575 mg


Capsule, hard


Oral use




Spain


Tecnimede España Ind. Fca., S.A.


Metamizol Tecnigen


metamizole


575 mg


Capsule, hard


Oral use




Spain


Teva Pharma S.L.U.,


Metamizol Ratiopharm


metamizole


575 mg


Capsule


Oral use




Spain


Teva Pharma S.L.U.,


Metamizol Teva-Ratiopharm


metamizole


575 mg


Capsule, hard


Oral use




Spain


Towa Pharmaceutical S.A.


Metamizol Pensa


metamizole


575 mg


Capsule, hard


Oral use




Spain


Towa Pharmaceutical S.A.


Metamizol Pensa Pharma


metamizole


575 mg


Capsule, hard


Oral use




Spain


Viatris Pharmaceuticals, S.L.U.


Metamizol Viatris


metamizole


575 mg


Capsule, hard


Oral use







ELI: http://data.europa.eu/eli/C/2024/7476/oj
ISSN 1977-091X (electronic edition)