# Official Journal C 457/30 N

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 457 |
| | |
| English edition | Information and Notices | Volume 6530 November 2022 |

ISSN 1977-091X

Official Journal

of the European Union

C 457

English edition

Information and Notices

Volume 6530 November 2022

---

| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2022/C 457/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2022 to 31 October 2022(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council) | 1 |
| 2022/C 457/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2022 to 31 October 2022(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) | 9 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2022/C 457/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2022 to 31 October 2022(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

1

2022/C 457/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2022 to 31 October 2022(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)

(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)

9

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 30.11.2022 | EN | Official Journal of the European Union | C 457/1 |
| --- | --- | --- | --- |

30.11.2022

EN

Official Journal of the European Union

C 457/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2022 to 31 October 2022

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2))

(2022/C 457/01)

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.10.2022 | Spikevax | elasomeran | MODERNA BIOTECH SPAIN, S.L. |
| Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

3.10.2022

Spikevax

elasomeran

MODERNA BIOTECH SPAIN, S.L.

Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

dispersion for injection

J07BX03

5.10.2022

10.10.2022

Comirnaty

tozinameran, COVID-19 mRNA vaccine (nucleoside-modified)

| BioNTech Manufacturing GmbH |
| --- |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

Concentrate for dispersion for injection

dispersion for injection

J07BX03

10.10.2022

31.10.2022

Beyfortus

nirsevimab

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/22/1689

Solution for injection

J06BD08

3.11.2022

31.10.2022

Vaxzevria

COVID-19 Vaccine (ChAdOx1-S [recombinant])

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

Suspension for injection

J07BX03

31.10.2022

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.10.2022 | Genvoya | Gilead Sciences Ireland UC |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.10.2022

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

4.10.2022

3.10.2022

Nuvaxovid

| Novavax CZ, a.s. |
| --- |
| Bohumil 138, 281 63 Jevany, Česká republika |

Novavax CZ, a.s.

Bohumil 138, 281 63 Jevany, Česká republika

EU/1/21/1618

5.10.2022

7.10.2022

Byfavo

| PAION Deutschland GmbH |
| --- |
| Heussstraße 25, 52078 Aachen, Deutschland |

PAION Deutschland GmbH

Heussstraße 25, 52078 Aachen, Deutschland

EU/1/20/1505

13.10.2022

7.10.2022

Pirfenidone axunio

| axunio Pharma GmbH |
| --- |
| Van-der-Smissen-Straße 1, 22767 Hamburg, Deutschland |

axunio Pharma GmbH

Van-der-Smissen-Straße 1, 22767 Hamburg, Deutschland

EU/1/22/1655

13.10.2022

7.10.2022

Sunosi

| TMC Pharma (EU) Limited |
| --- |
| 7a Durands Court, 45 Parnell Street, Waterford, Co. Waterford, X91 P381, Ireland |

TMC Pharma (EU) Limited

7a Durands Court, 45 Parnell Street, Waterford, Co. Waterford, X91 P381, Ireland

EU/1/19/1408

10.10.2022

12.10.2022

Aripiprazole Sandoz

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1029

13.10.2022

14.10.2022

Adtralza

| Leo Pharma A/S |
| --- |
| Industriparken 55, 2750 Ballerup, Danmark |

Leo Pharma A/S

Industriparken 55, 2750 Ballerup, Danmark

EU/1/21/1554

19.10.2022

14.10.2022

ALPROLIX

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| 112 76 Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/16/1098

18.10.2022

14.10.2022

Alunbrig

| Takeda Pharma A/S |
| --- |
| Delta Park 45, 2665 Vallensbaek Strand, Danmark |

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/18/1264

17.10.2022

14.10.2022

ARIKAYCE liposomal

| Insmed Netherlands B.V. |
| --- |
| Stadsplateau 7, 3521 AZ Utrecht, Nederland |

Insmed Netherlands B.V.

Stadsplateau 7, 3521 AZ Utrecht, Nederland

EU/1/20/1469

6.11.2022

14.10.2022

Bexsero

| GlaxoSmithKline Vaccines S.r.l. |
| --- |
| Via Fiorentina, 1, 53100 Siena, Italia |

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

17.10.2022

14.10.2022

Cegfila

| Mundipharma Corporation (Ireland) Limited |
| --- |
| Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland |

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/19/1409

19.10.2022

14.10.2022

Cystagon

| Recordati Rare Diseases |
| --- |
| Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France |

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/97/039

17.10.2022

14.10.2022

Drovelis

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21, 1103 Budapest, Magyarország |

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/21/1547

17.10.2022

14.10.2022

Dzuveo

| Laboratoire Aguettant |
| --- |
| 1 Rue Alexander Fleming, 69007 Lyon, France |

Laboratoire Aguettant

1 Rue Alexander Fleming, 69007 Lyon, France

EU/1/18/1284

17.10.2022

14.10.2022

ELZONRIS

| Stemline Therapeutics B.V. |
| --- |
| Basisweg 10, 1043 AP, Amsterdam, Noord-Holland, Nederland |

Stemline Therapeutics B.V.

Basisweg 10, 1043 AP, Amsterdam, Noord-Holland, Nederland

EU/1/20/1504

18.10.2022

14.10.2022

Empliciti

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/16/1088

17.10.2022

14.10.2022

Entacapone Orion

| Orion Corporation |
| --- |
| Orionintie 1, 02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/708

17.10.2022

14.10.2022

Icandra

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/08/484

18.10.2022

14.10.2022

Imlygic

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1064

17.10.2022

14.10.2022

Imnovid

| Bristol Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland |

Bristol Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

EU/1/13/850

17.10.2022

14.10.2022

KEYTRUDA

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

17.10.2022

14.10.2022

Nepexto

| Mylan IRE Healthcare Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland |

Mylan IRE Healthcare Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/20/1436

17.10.2022

14.10.2022

Nevanac

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/07/433

17.10.2022

14.10.2022

Nilemdo

| Daiichi Sankyo Europe GmbH |
| --- |
| Zielstattstraße 48, 81379 München, Deutschland |

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1425

18.11.2022

14.10.2022

Nustendi

| Daiichi Sankyo Europe GmbH |
| --- |
| Zielstattstraße 48, 81379 München, Deutschland |

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1424

20.10.2022

14.10.2022

Omnitrope

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/06/332

17.10.2022

14.10.2022

Ovitrelle

| Merck Europe B.V. |
| --- |
| Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/00/165

17.10.2022

14.10.2022

Pergoveris

| Merck Europe B.V. |
| --- |
| Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/07/396

17.10.2022

14.10.2022

Revlimid

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/07/391

17.10.2022

14.10.2022

Revolade

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/10/612

17.10.2022

14.10.2022

Skyrizi

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1361

17.10.2022

14.10.2022

Vectibix

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/07/423

17.10.2022

14.10.2022

Xolair

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/05/319

17.10.2022

14.10.2022

Yescarta

| Kite Pharma EU B.V. |
| --- |
| Tufsteen 1, 2132 NT Hoofddorp, Nederland |

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/18/1299

17.10.2022

14.10.2022

Zomarist

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/08/483

17.10.2022

20.10.2022

Anagrelide Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/17/1256

21.10.2022

20.10.2022

Comirnaty

| BioNTech Manufacturing GmbH |
| --- |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

20.10.2022

20.10.2022

Dynastat

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/02/209

21.10.2022

20.10.2022

Evra

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21, 1103 Budapest, Magyarország |

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/02/223

25.10.2022

20.10.2022

Orkambi

| Vertex Pharmaceuticals (Ireland) Limited |
| --- |
| Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland |

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

EU/1/15/1059

21.10.2022

20.10.2022

Paxlovid

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/22/1625

21.10.2022

20.10.2022

Rapamune

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/01/171

21.10.2022

20.10.2022

Rezolsta

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

21.10.2022

20.10.2022

Spikevax

| MODERNA BIOTECH SPAIN, S.L. |
| --- |
| Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España |

MODERNA BIOTECH SPAIN, S.L.

Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

20.10.2022

20.10.2022

Vaxzevria

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

20.10.2022

20.10.2022

Veklury

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

20.10.2022

20.10.2022

Xelevia

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/382

24.10.2022

21.10.2022

Eylea

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

24.10.2022

21.10.2022

Inflectra

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/13/854

24.10.2022

21.10.2022

Vaxneuvance

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/21/1591

24.10.2022

28.10.2022

Brukinsa

| BeiGene Ireland Limited |
| --- |
| 10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland |

BeiGene Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland

EU/1/21/1576

3.11.2022

28.10.2022

Comirnaty

| BioNTech Manufacturing GmbH |
| --- |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

28.10.2022

28.10.2022

Enhertu

| Daiichi Sankyo Europe GmbH |
| --- |
| Zielstattstraße 48, 81379 München, Deutschland |

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

3.11.2022

28.10.2022

REKAMBYS

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1482

2.11.2022

28.10.2022

VPRIV

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/10/646

2.11.2022

28.10.2022

XALKORI

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/12/793

2.11.2022

31.10.2022

Adasuve

| Ferrer Internacional S.A. |
| --- |
| Gran Via Carlos III, 94 08028 Barcelona, España |

Ferrer Internacional S.A.

Gran Via Carlos III, 94 08028 Barcelona, España

EU/1/13/823

7.11.2022

31.10.2022

JCOVDEN

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

2.11.2022

31.10.2022

Ofev

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

3.11.2022

31.10.2022

Pregabalin Mylan

| Mylan Pharmaceuticals Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |

Mylan Pharmaceuticals Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

EU/1/15/997

3.11.2022

31.10.2022

Rivastigmine HEXAL

| Hexal AG |
| --- |
| Industriestraße 25, 83607 Holzkirchen, Deutschland |

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/09/589

8.11.2022

31.10.2022

RXULTI

| Otsuka Pharmaceutical Netherlands B.V. |
| --- |
| Herikerbergweg 292, 1101 CT, Amsterdam, Nederland |

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/18/1294

7.11.2022

31.10.2022

Tafinlar

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/13/865

3.11.2022

31.10.2022

Zercepac

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/20/1456

3.11.2022

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.10.2022 | Improvac | Zoetis Belgium S.A. |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

7.10.2022

Improvac

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/09/095

10.10.2022

7.10.2022

Rabitec

| Ceva Santé Animale |
| --- |
| 10 avenue de La Ballastière, 33500 Libourne, France |

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/219

10.10.2022

7.10.2022

Tulinovet

| V.M.D.n.v. |
| --- |
| Hoge Mauw 900, 2370 Arendonk, Belgïe |

V.M.D.n.v.

Hoge Mauw 900, 2370 Arendonk, Belgïe

EU/2/20/257

14.10.2022

7.10.2022

Virbagen Omega

| VIRBAC |
| --- |
| 1ère Avenue — 2065m — L.I.D., 06516 CARROS, France |

VIRBAC

1ère Avenue — 2065m — L.I.D., 06516 CARROS, France

EU/2/01/030

10.10.2022

17.10.2022

Bonqat

| Orion Corporation |
| --- |
| Orionintie 1, 02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/21/273

19.10.2022

17.10.2022

Bovilis Blue-8

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/17/218

18.10.2022

17.10.2022

Chanhold

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Loughrea, Co. Galway, Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/19/236

18.10.2022

17.10.2022

CLYNAV

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/197

18.10.2022

17.10.2022

Easotic

| VIRBAC |
| --- |
| 1ère avenue 2065 m LID, 06516 Carros, France |

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/08/085

19.10.2022

17.10.2022

EVICTO

| VIRBAC |
| --- |
| 1ère avenue 2065 m LID, 06516 Carros, France |

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/19/242

18.10.2022

17.10.2022

MHYOSPHERE PCV ID

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, 17170 Amer (Girona), España |

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/20/259

18.10.2022

17.10.2022

Nobivac LeuFel

| VIRBAC |
| --- |
| 1ère avenue 2065 m LID, 06516 Carros, France |

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/17/217

18.10.2022

17.10.2022

Poulvac E. coli

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/12/140

18.10.2022

17.10.2022

Rabigen SAG2

| VIRBAC S.A. |
| --- |
| 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France |

VIRBAC S.A.

1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France

EU/2/00/021

19.10.2022

25.10.2022

EVICTO

| VIRBAC |
| --- |
| 1ère avenue 2065 m LID, 06516 Carros, France |

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/19/242

26.10.2022

25.10.2022

Exzolt

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/17/212

26.10.2022

25.10.2022

Solensia

| Zoetis Belgium SA |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium SA

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/20/269

26.10.2022

28.10.2022

Improvac

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/09/095

2.11.2022

28.10.2022

Improvac

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/09/095

2.11.2022

28.10.2022

Porcilis PCV M Hyo

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/175

1.11.2022

28.10.2022

PREVEXXION RN

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/254

2.11.2022

28.10.2022

PREVEXXION RN+HVT+IBD

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/255

2.11.2022

28.10.2022

Purevax RCPCh

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/050

2.11.2022

28.10.2022

Vaxxitek HVT + IBD

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/02/032

2.11.2022

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

(1)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 4, 7.1.2019, p. 43.

---

| 30.11.2022 | EN | Official Journal of the European Union | C 457/9 |
| --- | --- | --- | --- |

30.11.2022

EN

Official Journal of the European Union

C 457/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2022 to 31 October 2022

(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))

(2022/C 457/02)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 28.10.2022 | Nomegestrol and Chlormadinone | nomegestrol or chlormadinone | See Annex | See Annex | 31.10.2022 |

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

28.10.2022

Nomegestrol and Chlormadinone

nomegestrol or chlormadinone

See Annex

See Annex

31.10.2022

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

(3)  OJ L 4, 7.1.2019, p. 43.

---

ANNEX

List of nationally authorised medicinal products

Nationally authorised medicinal products containing nomegestrol

| Member State in EEA | Marketing Authorisation Holder | Product Name | INN/Active Substance + Strength | Pharmaceutical Form | Route of Administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Ceres Pharma Nv | Nogest | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| Belgium | Stragen Nordic A/S | Nomegestrol Stragen | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| Belgium | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| Belgium | Theramex Ireland Limited | Naemis | Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet | Tablet | Oral Use |
| France | Arrow Generiques | Nomegestrol Arrow | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| France | Biogaran | Nomegestrol Biogaran | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| France | Eg Labo Laboratoires Eurogenerics | Nomegestrol Eg | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| France | Mylan S.A.S | Nomegestrol Mylan | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| France | Sandoz | Nomegestrol Sandoz | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| France | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 3,75  mg Tablet | Tablet | Oral Use |
| France | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| France | Theramex Ireland Limited | Naemis | Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet | Tablet | Oral Use |
| Italy | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| Italy | Theramex Ireland Limited | Naemis | Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet | Tablet | Oral Use |
| Luxembourg | Ceres Pharma Nv | Nogest | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| Luxembourg | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| Luxembourg | Theramex Ireland Limited | Naemis | Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet | Tablet | Oral Use |
| Poland | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |
| Portugal | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | Tablet | Oral Use |

Member State in EEA

Marketing Authorisation Holder

Product Name

INN/Active Substance + Strength

Pharmaceutical Form

Route of Administration

Belgium

Ceres Pharma Nv

Nogest

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Belgium

Stragen Nordic A/S

Nomegestrol Stragen

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Belgium

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Belgium

Theramex Ireland Limited

Naemis

Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet

Tablet

Oral Use

France

Arrow Generiques

Nomegestrol Arrow

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

France

Biogaran

Nomegestrol Biogaran

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

France

Eg Labo Laboratoires Eurogenerics

Nomegestrol Eg

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

France

Mylan S.A.S

Nomegestrol Mylan

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

France

Sandoz

Nomegestrol Sandoz

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

France

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 3,75  mg Tablet

Tablet

Oral Use

France

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

France

Theramex Ireland Limited

Naemis

Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet

Tablet

Oral Use

Italy

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Italy

Theramex Ireland Limited

Naemis

Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet

Tablet

Oral Use

Luxembourg

Ceres Pharma Nv

Nogest

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Luxembourg

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Luxembourg

Theramex Ireland Limited

Naemis

Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet

Tablet

Oral Use

Poland

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Portugal

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Nationally authorised medicinal products containing chlormadinone

| Member State in EEA | Marketing Authorisation Holder | Product Name | INN/Active Substance + Strength | Pharmaceutical Form | Route of Administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Dermapharm Gmbh | Madinette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Austria | Gedeon Richter Plc. | Balanca | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Austria | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Austria | Gynial Gmbh | Bilinda Gynial | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Austria | Kwizda Pharma Gmbh | Delia | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Belgium | Ceres Pharma Nv | Helen | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Belgium | Gedeon Richter Plc. | Bellina | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Belgium | S.A. Meda Pharma N.V. | Orchidea | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Bulgaria | Gedeon Richter Plc. | Белара 21+7 | Chlormadinone Acetate 2 mg, Ethinylestradiol 0,03  mg | Lactose Monohydrate 94,44  mg | Film-Coated Tablet | Oral Use |
| Croatia | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Croatia | Mibe Pharmaceuticals D.O.O. | Estal | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Czech Republic | Aristo Pharma Gmbh (Art 57) | Clormetin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Czech Republic | Exeltis Czech S.R.O. | Lydely | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Czech Republic | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Czech Republic | Heaton K.S. | Flaya | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet | Coated Tablet | Oral Use |
| Czech Republic | Stada Arzneimittel Ag | Bonissa | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Estonia | Uab Exeltis Baltics | Clormetin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol Ph. Eur. 0,03  mg Tablet | Film-Coated Tablet | Oral |
| France | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| France | Gedeon Richter Plc. | Belaracontinu | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | Film-Coated Tablet | Oral Use |
| France | Mylan S.A.S | Chlormadinone Mylan | Chlormadinone Acetate 10 mg Tablet | Tablet | Oral Use |
| France | Mylan S.A.S | Chlormadinone Mylan | Chlormadinone Acetate 5 mg Tablet | Tablet | Oral Use |
| France | Sandoz | Chlormadinone Sandoz | Chlormadinone Acetate 10 mg Tablet | Tablet | Oral Use |
| France | Sandoz | Chlormadinone Sandoz | Chlormadinone Acetate 5 mg Tablet | Tablet | Oral Use |
| France | Sanofi-Aventis France | Luteran | Chlormadinone Acetate 10 mg Tablet | Tablet | Oral Use |
| France | Sanofi-Aventis France | Luteran | Chlormadinone Acetate 5 mg Tablet | Tablet | Oral Use |
| France | Teva Santé | Chlormadinone Teva | Chlormadinone Acetate 10 mg Tablet | Tablet | Oral Use |
| France | Teva Santé | Chlormadinone Teva | Chlormadinone Acetate 5 mg Tablet | Tablet | Oral Use |
| Germany | Acis Arzneimittel Gmbh | Madinance | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Aliud Pharma Gmbh | Bonita | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Aristo Pharma Gmbh (Art 57) | Lilia | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Besins Healthcare Germany Gmbh | Minette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Gedeon Richter Plc. | Balanca | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Gedeon Richter Plc. | Belara 21+7 | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Gedeon Richter Plc. | Chariva | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Gedeon Richter Plc. | Chariva 21+7 | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Gedeon Richter Plc. | Ethinylestradiol/Chlormadinonacetat 21+7 Richter | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 94,44  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Gedeon Richter Plc. | Ethinylestradiol/Chlormadinonacetat Richter | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Gedeon Richter Plc. | Neo-Eunomin | Chlormadinone Acetate 1mg Tablet, Ethinylestradiol 0,05  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Gedeon Richter Plc. | Neo-Eunomin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,05  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Hexal Ag | Mona | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Hormosan Pharma Gmbh | Solera | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Jenapharm Gmbh & Co Kg | Chlormadinon Jenapharm | Chlormadinone Acetate 2 mg Tablet | Tablet | Oral Use |
| Germany | Jenapharm Gmbh & Co Kg | Enriqa | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Meda Pharma Gmbh & Co. Kg | Bellissima | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Meda Pharma Gmbh & Co. Kg | Bellissima 21+7 | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Mibe Gmbh Arzneimittel | Madinette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Mylan Germany Gmbh | Lisette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Puren Pharma Gmbh & Co. Kg | Angiletta | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Stadapharm Gmbh | Pink Luna | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Germany | Zentiva Pharma Gmbh | Chloee | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Greece | Elpen Pharmaceutical Co. Inc. | Labous | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Hungary | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Italy | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Italy | Gedeon Richter Plc. | Lybella | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Italy | Mylan S.P.A. | Mytulip | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Italy | Sandoz S.P.A. | Eve | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Latvia | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Latvia | Uab Exeltis Baltics | Clormetin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol Ph. Eur. 0,03  mg Tablet | Film-Coated Tablet | Oral |
| Lithuania | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet | Film-Coated Tablet | Oral Use |
| Luxembourg | Ceres Pharma Nv | Helen | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Luxembourg | Gedeon Richter Plc. | Bellina | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Luxembourg | Meda Pharma Gmbh & Co. Kg | Bellissima | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Poland | Actavis Group Ptc Ehf. | Angiletta | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Poland | Exeltis Poland Sp. Z O.O. | Clormetin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Poland | Gedeon Richter Polska Sp. Z. O.O. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Poland | Sun-Farm Sp. Z.O.O. | Madinette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Poland | Symphar Sp. Z O.O. | Symbella | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Portugal | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Portugal | Gedeon Richter Plc. | Chariva | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Portugal | Gedeon Richter Plc. | Libeli | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Portugal | Itf Farmahealth, Produtos Farmacêuticos, Lda | Clarissa | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Portugal | Laboratorios León Farma, S.A. | Bonae | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Romania | Gedeon Richter România S.A. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Romania | Gedeon Richter România S.A. | Belara Continu | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,32  mg Tablet | Film-Coated Tablet | Oral Use |
| Slovakia | Exeltis Slovakia | Lydely | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Slovakia | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Slovakia | Stada Arzneimittel Ag | Belissa | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Slovenia | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Spain | Aristo Pharma Iberia, S.L. | Clormadinona/Etinilestradiol Aristo | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Spain | Brill Pharma, S.L. | Elynor | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Spain | Gedeon Richter Plc. | Balianca | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Spain | Gedeon Richter Plc. | Balianca Diario | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | Film-Coated Tablet | Oral Use |
| Spain | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Spain | Gedeon Richter Plc. | Belara Diario | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | Film-Coated Tablet | Oral Use |
| Spain | Laboratorio Stada, S.L. | Clormadinona/Etinilestradiol Stadafarma | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |
| Spain | Laboratorio Stada, S.L. | Etinilestradiol/Clormadinona Stada | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Film-Coated Tablet | Oral Use |

Member State in EEA

Marketing Authorisation Holder

Product Name

INN/Active Substance + Strength

Pharmaceutical Form

Route of Administration

Austria

Dermapharm Gmbh

Madinette

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Austria

Gedeon Richter Plc.

Balanca

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Austria

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Austria

Gynial Gmbh

Bilinda Gynial

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Austria

Kwizda Pharma Gmbh

Delia

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Belgium

Ceres Pharma Nv

Helen

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Belgium

Gedeon Richter Plc.

Bellina

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Belgium

S.A. Meda Pharma N.V.

Orchidea

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Bulgaria

Gedeon Richter Plc.

Белара 21+7

Chlormadinone Acetate 2 mg, Ethinylestradiol 0,03  mg | Lactose Monohydrate 94,44  mg

Film-Coated Tablet

Oral Use

Croatia

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Croatia

Mibe Pharmaceuticals D.O.O.

Estal

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Czech Republic

Aristo Pharma Gmbh (Art 57)

Clormetin

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Czech Republic

Exeltis Czech S.R.O.

Lydely

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Czech Republic

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Czech Republic

Heaton K.S.

Flaya

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet

Coated Tablet

Oral Use

Czech Republic

Stada Arzneimittel Ag

Bonissa

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Estonia

Uab Exeltis Baltics

Clormetin

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol Ph. Eur. 0,03  mg Tablet

Film-Coated Tablet

Oral

France

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

France

Gedeon Richter Plc.

Belaracontinu

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet

Film-Coated Tablet

Oral Use

France

Mylan S.A.S

Chlormadinone Mylan

Chlormadinone Acetate 10 mg Tablet

Tablet

Oral Use

France

Mylan S.A.S

Chlormadinone Mylan

Chlormadinone Acetate 5 mg Tablet

Tablet

Oral Use

France

Sandoz

Chlormadinone Sandoz

Chlormadinone Acetate 10 mg Tablet

Tablet

Oral Use

France

Sandoz

Chlormadinone Sandoz

Chlormadinone Acetate 5 mg Tablet

Tablet

Oral Use

France

Sanofi-Aventis France

Luteran

Chlormadinone Acetate 10 mg Tablet

Tablet

Oral Use

France

Sanofi-Aventis France

Luteran

Chlormadinone Acetate 5 mg Tablet

Tablet

Oral Use

France

Teva Santé

Chlormadinone Teva

Chlormadinone Acetate 10 mg Tablet

Tablet

Oral Use

France

Teva Santé

Chlormadinone Teva

Chlormadinone Acetate 5 mg Tablet

Tablet

Oral Use

Germany

Acis Arzneimittel Gmbh

Madinance

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Aliud Pharma Gmbh

Bonita

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Aristo Pharma Gmbh (Art 57)

Lilia

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Besins Healthcare Germany Gmbh

Minette

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Balanca

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Belara 21+7

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Chariva

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Chariva 21+7

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Ethinylestradiol/Chlormadinonacetat 21+7 Richter

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 94,44  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Ethinylestradiol/Chlormadinonacetat Richter

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Neo-Eunomin

Chlormadinone Acetate 1mg Tablet, Ethinylestradiol 0,05  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Neo-Eunomin

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,05  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Hexal Ag

Mona

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Hormosan Pharma Gmbh

Solera

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Jenapharm Gmbh & Co Kg

Chlormadinon Jenapharm

Chlormadinone Acetate 2 mg Tablet

Tablet

Oral Use

Germany

Jenapharm Gmbh & Co Kg

Enriqa

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Meda Pharma Gmbh & Co. Kg

Bellissima

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Meda Pharma Gmbh & Co. Kg

Bellissima 21+7

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Mibe Gmbh Arzneimittel

Madinette

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Mylan Germany Gmbh

Lisette

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Puren Pharma Gmbh & Co. Kg

Angiletta

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Stadapharm Gmbh

Pink Luna

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Zentiva Pharma Gmbh

Chloee

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Greece

Elpen Pharmaceutical Co. Inc.

Labous

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Hungary

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Italy

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Italy

Gedeon Richter Plc.

Lybella

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Italy

Mylan S.P.A.

Mytulip

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Italy

Sandoz S.P.A.

Eve

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Latvia

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Latvia

Uab Exeltis Baltics

Clormetin

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol Ph. Eur. 0,03  mg Tablet

Film-Coated Tablet

Oral

Lithuania

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet

Film-Coated Tablet

Oral Use

Luxembourg

Ceres Pharma Nv

Helen

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Luxembourg

Gedeon Richter Plc.

Bellina

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Luxembourg

Meda Pharma Gmbh & Co. Kg

Bellissima

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Poland

Actavis Group Ptc Ehf.

Angiletta

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Poland

Exeltis Poland Sp. Z O.O.

Clormetin

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Poland

Gedeon Richter Polska Sp. Z. O.O.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Poland

Sun-Farm Sp. Z.O.O.

Madinette

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Poland

Symphar Sp. Z O.O.

Symbella

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Portugal

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Portugal

Gedeon Richter Plc.

Chariva

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Portugal

Gedeon Richter Plc.

Libeli

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Portugal

Itf Farmahealth, Produtos Farmacêuticos, Lda

Clarissa

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Portugal

Laboratorios León Farma, S.A.

Bonae

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Romania

Gedeon Richter România S.A.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Romania

Gedeon Richter România S.A.

Belara Continu

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,32  mg Tablet

Film-Coated Tablet

Oral Use

Slovakia

Exeltis Slovakia

Lydely

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Slovakia

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Slovakia

Stada Arzneimittel Ag

Belissa

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Slovenia

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Aristo Pharma Iberia, S.L.

Clormadinona/Etinilestradiol Aristo

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Brill Pharma, S.L.

Elynor

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Gedeon Richter Plc.

Balianca

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Gedeon Richter Plc.

Balianca Diario

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Gedeon Richter Plc.

Belara Diario

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Laboratorio Stada, S.L.

Clormadinona/Etinilestradiol Stadafarma

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Laboratorio Stada, S.L.

Etinilestradiol/Clormadinona Stada

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

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