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

Chlormadinone Ethinylestradiol

Kwizda Pharma GmbH

Austria

Madinette 0.03 mg/2 mg Filmtabletten

Chlormadinone Ethinylestradiol

Dermapharm GmbH

Austria

Mellow ratiopharm 0.03 mg/2 mg Filmtabletten

Chlormadinone Ethinylestradiol

Teva Pharma BV

Austria

Angiletta 0.03 mg/2 mg Filmtabletten

Chlormadinone Ethinylestradiol

Actavis Group PTC ehf

Austria

Balanca 0.03 mg/2 mg - Filmtabletten

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Austria

Beatrice 0.03 mg/2 mg Filmtabletten

Chlormadinone Ethinylestradiol

Pfizer Corporation Austria GmbH

Austria

Belara 0.03 mg/2 mg - Filmtabletten

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Austria

Bellissima 0.03 mg/2 mg Filmtabletten

Chlormadinone Ethinylestradiol

Madaus GmbH

Austria

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

Chlormadinone Ethinylestradiol

Hexal GmbH

Austria

BELLINA

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Belgium

HELEN

Chlormadinone Ethinylestradiol

Mithra Pharmaceuticals S.A.

Belgium

MADINELLE **

Chlormadinone Ethinylestradiol

Mibe GmbH Arzneimittel

Belgium

ORCHIDEA

Chlormadinone Ethinylestradiol

Madaus GmbH

Belgium

BELARA

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Czech Republic

BONISSA 0.03 MG/2 MG POTAHOVANÉ TABLETY

Chlormadinone Ethinylestradiol

Stada Arzneimittel AG

Czech Republic

CLORMETIN 2 MG/0.03 MG

Chlormadinone Ethinylestradiol

WH-Pharma s.r.o.

Czech Republic

ESETE 2 MG/0.03 MG

Chlormadinone Ethinylestradiol

Teva Pharmaceuticals CR, s.r.o.

Czech Republic

FLAYA 0.030 MG/2 MG POTAHOVANÉ TABLETY

Chlormadinone Ethinylestradiol

Heaton k.s.

Czech Republic

MADINELLE 0.03 MG/2 MG **

Chlormadinone Ethinylestradiol

Mibe GmbH Arzneimittel

Czech Republic

BELARA

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Estonia

CLORMETIN 2 MG/0.03 MG

Chlormadinone Ethinylestradiol

Ladee Pharma Baltics UAB

Estonia

Balanca

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

France

Balancacontinu

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

France

Belara

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

France

Belaracontinu

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

France

Chlormadinone Ethinylestradiol Actavis 2 mg/0.03 mg

Chlormadinone Ethinylestradiol

Arrow génériques SAS

France

Bonita AL 0.03 mg/2 mg Filmtabletten

Chlormadinone Ethinylestradiol

Aliud Pharma GmbH

Germany

Angiletta 2 mg/0.03 mg Filmtabletten

Chlormadinone Ethinylestradiol

Actavis Group PTC ehf

Germany

Balanca

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Germany

Beatrice 0.03 mg/2 mg Filmtabletten

Chlormadinone Ethinylestradiol

Pfizer Pharma GmbH

Germany

Belara

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Germany

Belara 21+7

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Germany

Bellissima

Chlormadinone Ethinylestradiol

Madaus GmbH

Germany

Bellissima 0.03 mg/2 mg filmtabletten

Chlormadinone Ethinylestradiol

Madaus GmbH

Germany

Bilmon - 1 A Pharma 0.03 mg/2 mg Filmtabletten

Chlormadinone Ethinylestradiol

1 A Pharma GmbH

Germany

Chantal

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Germany

Chariva

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Germany

Chariva 21+7

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Germany

Chloee

Chlormadinone Ethinylestradiol

Zentiva Pharma GmbH

Germany

Enriqa

Chlormadinone Acetate Ethinylestradiol

Jenapharm GmbH & Co. KG

Germany

Eufem 2 mg/0.03 mg Filmtabletten

Chlormadinone Ethinylestradiol

Sandoz Pharmaceuticals GmbH

Germany

LaBibiane

Chlormadinone Ethinylestradiol

TEVA GmbH

Germany

Lilia 0.03 mg/2 mg Filmtabletten

Chlormadinone Ethinylestradiol

Aristo Pharma GmbH

Germany

Lisa

Chlormadinone Ethinylestradiol

Madaus GmbH

Germany

Page 1

Name of the product

INN

Marketing Authorisation Holder

Country where product is authorised

Lisette 0.03 mg/2 mg Filmtabletten

Chlormadinone Ethinylestradiol

Mylan dura gmbH

Germany

Madinette 30

Chlormadinone Ethinylestradiol

Mibe GmbH Arzneimittel

Germany

Minette 2 mg/0.03 mg Filmtabletten

Chlormadinone Ethinylestradiol

Dr. Kade Pharmazeutische Fabrik GmbH

Germany

Mona HEXAL 2 mg/0.03 mg Filmtabletten

Chlormadinone Ethinylestradiol

Hexal Aktiengesellschaft

Germany

Neo - Eunomin

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Germany

Pink Luna 0.03 mg/2 mg Filmtabletten

Chlormadinone Ethinylestradiol

Stadapharm GmbH

Germany

Solera 2 mg/0.03 mg Filmtabletten

Chlormadinone Ethinylestradiol

Hormosan Pharma GmbH

Germany

Bellissima 21+7

Chlormadinone Ethinylestradiol

Madaus GmbH

Germany

Verana - ratiopharm 2 mg/0.03 mg Filmtabletten

Chlormadinone Ethinylestradiol

Ratiopharm GmbH

Germany

Belara

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Germany

Belara

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Hungary

Claranette - ratiopharm

Chlormadinone Ethinylestradiol

Ratiopharm GmbH

Hungary

Clormetin

Chlormadinone Ethinylestradiol

Laboratorios Leon Farma SA

Hungary

TYARENA

Chlormadinone Ethinylestradiol

Teva Italia S.r.l.

Italy

BELARA

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Italy

EVE

Chlormadinone Ethinylestradiol

Sandoz Spa

Italy

CLORETINYL

Chlormadinone Ethinylestradiol

Ratiopharm GmbH

Italy

CLORMADINONE ETINILESTRADIOLO MYLAN

Chlormadinone Ethinylestradiol

Mylan S.p.A.

Italy

NAVEEN

Chlormadinone Ethinylestradiol

EG S.p.A.

Italy

Clormetin 2 mg/0.03 mg film - coated tablets

Chlormadinone Ethinylestradiol

UAB Ladee Pharma Baltics

Latvia

Belara 0.03 mg/2 mg film - coated tablets

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Latvia

Belara

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Lithuania

Bellina

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Luxembourg

Bellissima

Chlormadinone Ethinylestradiol

Madaus GmbH

Luxembourg

Helen

Chlormadinone Ethinylestradiol

Mithra Pharmaceuticals S.A.

Luxembourg

Verana - ratiopharm

Chlormadinone Ethinylestradiol

Ratiopharm GmbH

Luxembourg

Madinette

Chlormadinone Ethinylestradiol

Sun-Farm Sp. z o.o.

Poland

Angiletta

Chlormadinone Ethinylestradiol

Actavis Group PTC ehf

Poland

Belara

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Portugal

Bonae

Chlormadinone Ethinylestradiol

Laboratorios Leon Farma SA

Portugal

Clarissa

Chlormadinone Ethinylestradiol

Italfarmaco - Produtos Farmacêuticos, Lda.

Portugal

Jeniasta

Chlormadinone Ethinylestradiol

Actavis Group PTC ehf

Portugal

Libeli

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Portugal

BELARA

Chlormadinone Ethinylestradiol

Gedeon Richter România S.A.

Romania

TYARENA 200 micrograme/30 micrograme

Chlormadinone Ethinylestradiol

Teva Pharmaceuticals S.R.L.

Romania

Angiletta 2 mg /0.03 mg

Chlormadinone Ethinylestradiol

Actavis Group PTC ehf

Slovak Republic

Belara

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Slovak Republic

Belissa

Chlormadinone Ethinylestradiol

Stada Arzneimittel AG

Slovak Republic

Egretta 2 mg/0.03 mg

Chlormadinone Ethinylestradiol

Ratiopharm GmbH

Slovak Republic

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

Chlormadinone Ethinylestradiol

Mibe GmbH Arzneimittel

Slovak Republic

Belara 0.03 mg/2 mg filmsko obložene tablete

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Slovenia

BALIANCA 0.03 mg/2mg COMPRIMIDOS RECUBIERTOS CON PELICULA

Chlormadinone Ethinylestradiol

FAES FARMA, S.A.

Spain

BALIANCA DIARIO 0.03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA

Chlormadinone Ethinylestradiol

FAES FARMA, S.A.

Spain

BELARA 0.03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Spain

BELARA DIARIO 0.03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA

Chlormadinone Ethinylestradiol

Gedeon Richter Plc.

Spain

ELYNOR 0.03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

Chlormadinone Ethinylestradiol

BRILL PHARMA, S.L.

Spain

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

Chlormadinone Ethinylestradiol

LABORATORIO STADA, S.L.

Spain

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

Chlormadinone Ethinylestradiol

LABORATORIOS CINFA, S.A.

Spain

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

Chlormadinone Ethinylestradiol

MADAUS GmbH

Spain Page 2

Name of the product

INN

Marketing Authorisation Holder

Country where product is authorised

* 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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