Annex IX - List of combined hormonal contraceptives containing ...

27 September 2017 EMA/344487/2014 correction 3* Patient Health Protection

List of combined hormonal contraceptives containing chlormadinone in the European Union Name of the product

INN

Marketing Authorisation Holder

Country where product is authorised

Bilinda 0.03 mg/2 mg Filmtabletten

Chlormadinone Ethinylestradiol

Gynial GmbH

Austria

Delia 0.03 mg/2 mg Filmtabletten


Kwizda Pharma GmbH

Austria

Madinette 0.03 mg/2 mg Filmtabletten


Dermapharm GmbH

Austria

Mellow ratiopharm 0.03 mg/2 mg Filmtabletten


Teva Pharma BV

Austria

Angiletta 0.03 mg/2 mg Filmtabletten


Actavis Group PTC ehf

Austria

Balanca 0.03 mg/2 mg - Filmtabletten


Gedeon Richter Plc.

Austria

Beatrice 0.03 mg/2 mg Filmtabletten


Pfizer Corporation Austria GmbH

Austria

Belara 0.03 mg/2 mg - Filmtabletten


Gedeon Richter Plc.

Austria

Bellissima 0.03 mg/2 mg Filmtabletten


Madaus GmbH

Austria

Ethinylestradiol/Chlor madinon Hexal 0.03 mg/2 mg - Filmtabletten


Hexal GmbH

Austria

BELLINA


Gedeon Richter Plc.

Belgium

HELEN


Mithra Pharmaceuticals S.A.

Belgium

MADINELLE **


Mibe GmbH Arzneimittel

Belgium

ORCHIDEA


Madaus GmbH

Belgium

BELARA


Gedeon Richter Plc.

Czech Republic

BONISSA 0.03 MG/2 MG POTAHOVANÉ TABLETY


Stada Arzneimittel AG

Czech Republic

CLORMETIN 2 MG/0.03 MG


WH-Pharma s.r.o.

Czech Republic

ESETE 2 MG/0.03 MG


Teva Pharmaceuticals CR, s.r.o.

Czech Republic

FLAYA 0.030 MG/2 MG POTAHOVANÉ TABLETY


Heaton k.s.

Czech Republic

MADINELLE 0.03 MG/2 MG **



Czech Republic

BELARA


Gedeon Richter Plc.

Estonia

CLORMETIN 2 MG/0.03 MG


Ladee Pharma Baltics UAB

Estonia

Balanca


Gedeon Richter Plc.

France

Balancacontinu


Gedeon Richter Plc.

France

Belara


Gedeon Richter Plc.

France

Belaracontinu


Gedeon Richter Plc.

France

Chlormadinone Ethinylestradiol Actavis 2 mg/0.03 mg


Arrow génériques SAS

France

Bonita AL 0.03 mg/2 mg Filmtabletten


Aliud Pharma GmbH

Germany

Angiletta 2 mg/0.03 mg Filmtabletten



Germany

Balanca


Gedeon Richter Plc.

Germany

Beatrice 0.03 mg/2 mg Filmtabletten


Pfizer Pharma GmbH

Germany

Belara


Gedeon Richter Plc.

Germany

Belara 21+7


Gedeon Richter Plc.

Germany

Bellissima


Madaus GmbH

Germany

Bellissima 0.03 mg/2 mg filmtabletten


Madaus GmbH

Germany

Bilmon - 1 A Pharma 0.03 mg/2 mg Filmtabletten


1 A Pharma GmbH

Germany

Chantal


Gedeon Richter Plc.

Germany

Chariva


Gedeon Richter Plc.

Germany

Chariva 21+7


Gedeon Richter Plc.

Germany

Chloee


Zentiva Pharma GmbH

Germany

Enriqa

Chlormadinone Acetate Ethinylestradiol

Jenapharm GmbH & Co. KG

Germany

Eufem 2 mg/0.03 mg Filmtabletten


Sandoz Pharmaceuticals GmbH

Germany

LaBibiane


TEVA GmbH

Germany

Lilia 0.03 mg/2 mg Filmtabletten


Aristo Pharma GmbH

Germany

Lisa


Madaus GmbH

Germany

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Name of the product

INN



Lisette 0.03 mg/2 mg Filmtabletten


Mylan dura gmbH

Germany

Madinette 30



Germany

Minette 2 mg/0.03 mg Filmtabletten


Dr. Kade Pharmazeutische Fabrik GmbH

Germany

Mona HEXAL 2 mg/0.03 mg Filmtabletten


Hexal Aktiengesellschaft

Germany

Neo - Eunomin


Gedeon Richter Plc.

Germany

Pink Luna 0.03 mg/2 mg Filmtabletten


Stadapharm GmbH

Germany

Solera 2 mg/0.03 mg Filmtabletten


Hormosan Pharma GmbH

Germany

Bellissima 21+7


Madaus GmbH

Germany

Verana - ratiopharm 2 mg/0.03 mg Filmtabletten


Ratiopharm GmbH

Germany

Belara


Gedeon Richter Plc.

Germany

Belara


Gedeon Richter Plc.

Hungary

Claranette - ratiopharm


Ratiopharm GmbH

Hungary

Clormetin


Laboratorios Leon Farma SA

Hungary

TYARENA


Teva Italia S.r.l.

Italy

BELARA


Gedeon Richter Plc.

Italy

EVE


Sandoz Spa

Italy

CLORETINYL


Ratiopharm GmbH

Italy

CLORMADINONE ETINILESTRADIOLO MYLAN


Mylan S.p.A.

Italy

NAVEEN


EG S.p.A.

Italy

Clormetin 2 mg/0.03 mg film - coated tablets


UAB Ladee Pharma Baltics

Latvia

Belara 0.03 mg/2 mg film - coated tablets


Gedeon Richter Plc.

Latvia

Belara


Gedeon Richter Plc.

Lithuania

Bellina


Gedeon Richter Plc.

Luxembourg

Bellissima


Madaus GmbH

Luxembourg

Helen


Mithra Pharmaceuticals S.A.

Luxembourg

Verana - ratiopharm


Ratiopharm GmbH

Luxembourg

Madinette


Sun-Farm Sp. z o.o.

Poland

Angiletta



Poland

Belara


Gedeon Richter Plc.

Portugal

Bonae


Laboratorios Leon Farma SA

Portugal

Clarissa


Italfarmaco - Produtos Farmacêuticos, Lda.

Portugal

Jeniasta



Portugal

Libeli


Gedeon Richter Plc.

Portugal

BELARA


Gedeon Richter România S.A.

Romania

TYARENA 200 micrograme/30 micrograme


Teva Pharmaceuticals S.R.L.

Romania

Angiletta 2 mg /0.03 mg



Slovak Republic

Belara


Gedeon Richter Plc.

Slovak Republic

Belissa


Stada Arzneimittel AG

Slovak Republic

Egretta 2 mg/0.03 mg


Ratiopharm GmbH

Slovak Republic

Etinylestradiol 0.03 mg/Chlormadinoniumacet at 2 mg mibe filmom obalene tablety **



Slovak Republic

Belara 0.03 mg/2 mg filmsko obložene tablete


Gedeon Richter Plc.

Slovenia

BALIANCA 0.03 mg/2mg COMPRIMIDOS RECUBIERTOS CON PELICULA


FAES FARMA, S.A.

Spain

BALIANCA DIARIO 0.03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA


FAES FARMA, S.A.

Spain

BELARA 0.03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA


Gedeon Richter Plc.

Spain

BELARA DIARIO 0.03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA


Gedeon Richter Plc.

Spain

ELYNOR 0.03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


BRILL PHARMA, S.L.

Spain

ETINILESTRADIOL/CL ORMADINONA STADA 0.03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


LABORATORIO STADA, S.L.

Spain

ETINILESTRADIOL/CL ORMADINONA CINFA 0.03 mg/2 mg comprimidos recubiertos con película EFG


LABORATORIOS CINFA, S.A.

Spain

ETINILESTRADIOL/CL ORMADINONA MADAUS 0.03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG


MADAUS GmbH

Spain Page 2

Name of the product

INN



* This annex was previously amended on 26 July 2017. ** These products have been withdrawn, therefore they are removed from this list.

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