# Službeni list C 457/30.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 457 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 65.30. studenoga 2022. |

ISSN 1977-1088

Službeni list

Europske unije

C 457

Hrvatsko izdanje

Informacije i objave

Godište 65.30. studenoga 2022.

---

| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2022/C 457/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2022. do 31. listopada 2022.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća ili Članak 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća) | 1 |
| 2022/C 457/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2022. do 31. listopada 2022.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC, člankom 38. Direktive 2001/82/EC ili člankom 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća) | 9 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2022/C 457/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2022. do 31. listopada 2022.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća ili Članak 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća ili Članak 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća)

1

2022/C 457/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2022. do 31. listopada 2022.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC, člankom 38. Direktive 2001/82/EC ili člankom 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća)

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC, člankom 38. Direktive 2001/82/EC ili člankom 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća)

9

---

| HR | |
| --- | --- |

HR

---

IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 30.11.2022 | HR | Službeni list Europske unije | C 457/1 |
| --- | --- | --- | --- |

30.11.2022

HR

Službeni list Europske unije

C 457/1

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2022. do 31. listopada 2022.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1) ili Članak 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća (2))

(2022/C 457/01)

—   Izdavanje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.10.2022. | Spikevax | elasomeran | MODERNA BIOTECH SPAIN, S.L. |
| Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España |

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

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

Disperzija za injekciju

J07BX03

5.10.2022.

10.10.2022.

Comirnaty

tozinameran, cjepivo protiv COVID-19 (mRNA, modificiranih nukleozida)

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

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

Disperzija za injekciju

Koncentrat za disperziju za injekciju

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

Otopina za injekciju

J06BD08

3.11.2022.

31.10.2022.

Vaxzevria

Cjepivo protiv bolesti COVID-19 (ChAdOx1-S [rekombinantno])

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

Suspenzija za injekciju

J07BX03

31.10.2022.

—   Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 3.10.2022. | Genvoya | Gilead Sciences Ireland UC |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

Anagrelid 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.

—   Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća; Članak 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 7.10.2022. | Improvac | Zoetis Belgium S.A. |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:

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

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

(1)  SL L 136, 30.4.2004, str. 1.

(2)  SL L 4, 7.1.2019, str. 43.

---

| 30.11.2022 | HR | Službeni list Europske unije | C 457/9 |
| --- | --- | --- | --- |

30.11.2022

HR

Službeni list Europske unije

C 457/9

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2022. do 31. listopada 2022.

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC (1), člankom 38. Direktive 2001/82/EC (2) ili člankom 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća (3))

(2022/C 457/02)

—   Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj(i) odobrenja za stavljanje u promet | Država članica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- | --- |
| 28.10.2022. | Nomegestrol and Chlormadinone | nomegestrol or chlormadinone | Vidi Prilog | Vidi Prilog | 31.10.2022. |

Datum odluke

Naziv(i) lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj(i) odobrenja za stavljanje u promet

Država članica na koju se odnosi

Datum obavijesti

28.10.2022.

Nomegestrol and Chlormadinone

nomegestrol or chlormadinone

Vidi Prilog

Vidi Prilog

31.10.2022.

---

(1)  SL L 311, 28.11.2001., str. 67.

(2)  SL L 311, 28.11.2001., str. 1.

(3)  SL L 4, 7.1.2019., str. 43.

---

PRILOG

Popis nacionalno odobrenih lijekova

Nacionalno odobreni lijekovi koji sadrže nomegestrol

| Država članica EGP-a | Nositelj odobrenja | Naziv lijeka | INN / Djelatna tvar + jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Belgija | Ceres Pharma Nv | Nogest | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Belgija | Stragen Nordic A/S | Nomegestrol Stragen | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Belgija | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Belgija | Theramex Ireland Limited | Naemis | Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet | tableta | kroz usta |
| Francuska | Arrow Generiques | Nomegestrol Arrow | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Francuska | Biogaran | Nomegestrol Biogaran | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Francuska | Eg Labo Laboratoires Eurogenerics | Nomegestrol Eg | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Francuska | Mylan S.A.S | Nomegestrol Mylan | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Francuska | Sandoz | Nomegestrol Sandoz | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Francuska | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 3,75  mg Tablet | tableta | kroz usta |
| Francuska | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Francuska | Theramex Ireland Limited | Naemis | Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet | tableta | kroz usta |
| Italija | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Italija | Theramex Ireland Limited | Naemis | Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet | tableta | kroz usta |
| Luksemburg | Ceres Pharma Nv | Nogest | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Luksemburg | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Luksemburg | Theramex Ireland Limited | Naemis | Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet | tableta | kroz usta |
| Poljska | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |
| Portugal | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | tableta | kroz usta |

Država članica EGP-a

Nositelj odobrenja

Naziv lijeka

INN / Djelatna tvar + jačina

Farmaceutski oblik

Put primjene

Belgija

Ceres Pharma Nv

Nogest

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Belgija

Stragen Nordic A/S

Nomegestrol Stragen

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Belgija

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Belgija

Theramex Ireland Limited

Naemis

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

tableta

kroz usta

Francuska

Arrow Generiques

Nomegestrol Arrow

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Francuska

Biogaran

Nomegestrol Biogaran

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Francuska

Eg Labo Laboratoires Eurogenerics

Nomegestrol Eg

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Francuska

Mylan S.A.S

Nomegestrol Mylan

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Francuska

Sandoz

Nomegestrol Sandoz

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Francuska

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 3,75  mg Tablet

tableta

kroz usta

Francuska

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Francuska

Theramex Ireland Limited

Naemis

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

tableta

kroz usta

Italija

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Italija

Theramex Ireland Limited

Naemis

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

tableta

kroz usta

Luksemburg

Ceres Pharma Nv

Nogest

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Luksemburg

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Luksemburg

Theramex Ireland Limited

Naemis

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

tableta

kroz usta

Poljska

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Portugal

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

tableta

kroz usta

Nacionalno odobreni lijekovi koji sadrže klormadinon

| Država članica EGP-a | Nositelj odobrenja | Naziv lijeka | INN / Djelatna tvar + jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Austrija | Dermapharm Gmbh | Madinette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Austrija | Gedeon Richter Plc. | Balanca | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Austrija | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Austrija | Gynial Gmbh | Bilinda Gynial | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Austrija | Kwizda Pharma Gmbh | Delia | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Belgija | Ceres Pharma Nv | Helen | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Belgija | Gedeon Richter Plc. | Bellina | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Belgija | S.A. Meda Pharma N.V. | Orchidea | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Bugarska | Gedeon Richter Plc. | Белара 21+7 | Chlormadinone Acetate 2 mg, Ethinylestradiol 0,03  mg | Lactose Monohydrate 94,44  mg | filmom obložena tableta | kroz usta |
| Hrvatska | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Hrvatska | Mibe Pharmaceuticals D.O.O. | Estal | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Češka Republika | Aristo Pharma Gmbh (Art 57) | Clormetin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Češka Republika | Exeltis Czech S.R.O. | Lydely | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Češka Republika | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Češka Republika | Heaton K.S. | Flaya | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet | filmom obložena tableta | kroz usta |
| Češka Republika | Stada Arzneimittel Ag | Bonissa | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Estonija | Uab Exeltis Baltics | Clormetin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol Ph. Eur. 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Francuska | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Francuska | Gedeon Richter Plc. | Belaracontinu | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | filmom obložena tableta | kroz usta |
| Francuska | Mylan S.A.S | Chlormadinone Mylan | Chlormadinone Acetate 10 mg Tablet | Tableta | Kroz usta |
| Francuska | Mylan S.A.S | Chlormadinone Mylan | Chlormadinone Acetate 5 mg Tablet | Tableta | Kroz usta |
| Francuska | Sandoz | Chlormadinone Sandoz | Chlormadinone Acetate 10 mg Tablet | Tableta | Kroz usta |
| Francuska | Sandoz | Chlormadinone Sandoz | Chlormadinone Acetate 5 mg Tablet | Tableta | Kroz usta |
| Francuska | Sanofi-Aventis France | Luteran | Chlormadinone Acetate 10 mg Tablet | Tableta | Kroz usta |
| Francuska | Sanofi-Aventis France | Luteran | Chlormadinone Acetate 5 mg Tablet | Tableta | Kroz usta |
| Francuska | Teva Santé | Chlormadinone Teva | Chlormadinone Acetate 10 mg Tablet | Tableta | Kroz usta |
| Francuska | Teva Santé | Chlormadinone Teva | Chlormadinone Acetate 5 mg Tablet | tableta | kroz usta |
| Njemačka | Acis Arzneimittel Gmbh | Madinance | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Aliud Pharma Gmbh | Bonita | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Aristo Pharma Gmbh (Art 57) | Lilia | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Besins Healthcare Germany Gmbh | Minette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Gedeon Richter Plc. | Balanca | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Gedeon Richter Plc. | Belara 21+7 | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Gedeon Richter Plc. | Chariva | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Gedeon Richter Plc. | Chariva 21+7 | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Gedeon Richter Plc. | Ethinylestradiol/Chlormadinonacetat 21+7 Richter | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 94,44  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Gedeon Richter Plc. | Ethinylestradiol/Chlormadinonacetat Richter | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Gedeon Richter Plc. | Neo-Eunomin | Chlormadinone Acetate 1mg Tablet, Ethinylestradiol 0,05  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Gedeon Richter Plc. | Neo-Eunomin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,05  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Hexal Ag | Mona | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Hormosan Pharma Gmbh | Solera | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Jenapharm Gmbh & Co Kg | Chlormadinon Jenapharm | Chlormadinone Acetate 2 mg Tablet | tableta | kroz usta |
| Njemačka | Jenapharm Gmbh & Co Kg | Enriqa | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Meda Pharma Gmbh & Co. Kg | Bellissima | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Meda Pharma Gmbh & Co. Kg | Bellissima 21+7 | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Mibe Gmbh Arzneimittel | Madinette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Mylan Germany Gmbh | Lisette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Puren Pharma Gmbh & Co. Kg | Angiletta | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Stadapharm Gmbh | Pink Luna | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Njemačka | Zentiva Pharma Gmbh | Chloee | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Grčka | Elpen Pharmaceutical Co. Inc. | Labous | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Mađarska | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Italija | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Italija | Gedeon Richter Plc. | Lybella | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Italija | Mylan S.P.A. | Mytulip | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Italija | Sandoz S.P.A. | Eve | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Latvija | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Latvija | Uab Exeltis Baltics | Clormetin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol Ph. Eur. 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Litva | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet | filmom obložena tableta | kroz usta |
| Luksemburg | Ceres Pharma Nv | Helen | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Luksemburg | Gedeon Richter Plc. | Bellina | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Luksemburg | Meda Pharma Gmbh & Co. Kg | Bellissima | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Poljska | Actavis Group Ptc Ehf. | Angiletta | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Poljska | Exeltis Poland Sp. Z O.O. | Clormetin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Poljska | Gedeon Richter Polska Sp. Z. O.O. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Poljska | Sun-Farm Sp. Z.O.O. | Madinette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Poljska | Symphar Sp. Z O.O. | Symbella | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Portugal | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Filmom obložena tableta | kroz usta |
| Portugal | Gedeon Richter Plc. | Chariva | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Portugal | Gedeon Richter Plc. | Libeli | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Portugal | Itf Farmahealth, Produtos Farmacêuticos, Lda | Clarissa | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Portugal | Laboratorios León Farma, S.A. | Bonae | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Rumunjska | Gedeon Richter România S.A. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Rumunjska | Gedeon Richter România S.A. | Belara Continu | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,32  mg Tablet | filmom obložena tableta | kroz usta |
| Slovačka | Exeltis Slovakia | Lydely | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Slovačka | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Slovačka | Stada Arzneimittel Ag | Belissa | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Slovenija | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Španjolska | Aristo Pharma Iberia, S.L. | Clormadinona/Etinilestradiol Aristo | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Španjolska | Brill Pharma, S.L. | Elynor | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Španjolska | Gedeon Richter Plc. | Balianca | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Španjolska | Gedeon Richter Plc. | Balianca Diario | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | filmom obložena tableta | kroz usta |
| Španjolska | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Španjolska | Gedeon Richter Plc. | Belara Diario | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | filmom obložena tableta | kroz usta |
| Španjolska | Laboratorio Stada, S.L. | Clormadinona/Etinilestradiol Stadafarma | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |
| Španjolska | Laboratorio Stada, S.L. | Etinilestradiol/Clormadinona Stada | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | filmom obložena tableta | kroz usta |

Država članica EGP-a

Nositelj odobrenja

Naziv lijeka

INN / Djelatna tvar + jačina

Farmaceutski oblik

Put primjene

Austrija

Dermapharm Gmbh

Madinette

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

filmom obložena tableta

kroz usta

Austrija

Gedeon Richter Plc.

Balanca

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

filmom obložena tableta

kroz usta

Austrija

Gedeon Richter Plc.

Belara

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

filmom obložena tableta

kroz usta

Austrija

Gynial Gmbh

Bilinda Gynial

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

filmom obložena tableta

kroz usta

Austrija

Kwizda Pharma Gmbh

Delia

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

filmom obložena tableta

kroz usta

Belgija

Ceres Pharma Nv

Helen

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

filmom obložena tableta

kroz usta

Belgija

Gedeon Richter Plc.

Bellina

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

filmom obložena tableta

kroz usta

Belgija

S.A. Meda Pharma N.V.

Orchidea

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

filmom obložena tableta

kroz usta

Bugarska

Gedeon Richter Plc.

Белара 21+7

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

filmom obložena tableta

kroz usta

Hrvatska

Gedeon Richter Plc.

Belara

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

filmom obložena tableta

kroz usta

Hrvatska

Mibe Pharmaceuticals D.O.O.

Estal

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

filmom obložena tableta

kroz usta

Češka Republika

Aristo Pharma Gmbh (Art 57)

Clormetin

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

filmom obložena tableta

kroz usta

Češka Republika

Exeltis Czech S.R.O.

Lydely

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

filmom obložena tableta

kroz usta

Češka Republika

Gedeon Richter Plc.

Belara

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

filmom obložena tableta

kroz usta

Češka Republika

Heaton K.S.

Flaya

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet

filmom obložena tableta

kroz usta

Češka Republika

Stada Arzneimittel Ag

Bonissa

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

filmom obložena tableta

kroz usta

Estonija

Uab Exeltis Baltics

Clormetin

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

filmom obložena tableta

kroz usta

Francuska

Gedeon Richter Plc.

Belara

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

filmom obložena tableta

kroz usta

Francuska

Gedeon Richter Plc.

Belaracontinu

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

filmom obložena tableta

kroz usta

Francuska

Mylan S.A.S

Chlormadinone Mylan

Chlormadinone Acetate 10 mg Tablet

Tableta

Kroz usta

Francuska

Mylan S.A.S

Chlormadinone Mylan

Chlormadinone Acetate 5 mg Tablet

Tableta

Kroz usta

Francuska

Sandoz

Chlormadinone Sandoz

Chlormadinone Acetate 10 mg Tablet

Tableta

Kroz usta

Francuska

Sandoz

Chlormadinone Sandoz

Chlormadinone Acetate 5 mg Tablet

Tableta

Kroz usta

Francuska

Sanofi-Aventis France

Luteran

Chlormadinone Acetate 10 mg Tablet

Tableta

Kroz usta

Francuska

Sanofi-Aventis France

Luteran

Chlormadinone Acetate 5 mg Tablet

Tableta

Kroz usta

Francuska

Teva Santé

Chlormadinone Teva

Chlormadinone Acetate 10 mg Tablet

Tableta

Kroz usta

Francuska

Teva Santé

Chlormadinone Teva

Chlormadinone Acetate 5 mg Tablet

tableta

kroz usta

Njemačka

Acis Arzneimittel Gmbh

Madinance

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

filmom obložena tableta

kroz usta

Njemačka

Aliud Pharma Gmbh

Bonita

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

filmom obložena tableta

kroz usta

Njemačka

Aristo Pharma Gmbh (Art 57)

Lilia

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

filmom obložena tableta

kroz usta

Njemačka

Besins Healthcare Germany Gmbh

Minette

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

filmom obložena tableta

kroz usta

Njemačka

Gedeon Richter Plc.

Balanca

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

filmom obložena tableta

kroz usta

Njemačka

Gedeon Richter Plc.

Belara

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

filmom obložena tableta

kroz usta

Njemačka

Gedeon Richter Plc.

Belara 21+7

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

filmom obložena tableta

kroz usta

Njemačka

Gedeon Richter Plc.

Chariva

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

filmom obložena tableta

kroz usta

Njemačka

Gedeon Richter Plc.

Chariva 21+7

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

filmom obložena tableta

kroz usta

Njemačka

Gedeon Richter Plc.

Ethinylestradiol/Chlormadinonacetat 21+7 Richter

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

filmom obložena tableta

kroz usta

Njemačka

Gedeon Richter Plc.

Ethinylestradiol/Chlormadinonacetat Richter

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

filmom obložena tableta

kroz usta

Njemačka

Gedeon Richter Plc.

Neo-Eunomin

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

filmom obložena tableta

kroz usta

Njemačka

Gedeon Richter Plc.

Neo-Eunomin

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

filmom obložena tableta

kroz usta

Njemačka

Hexal Ag

Mona

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

filmom obložena tableta

kroz usta

Njemačka

Hormosan Pharma Gmbh

Solera

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

filmom obložena tableta

kroz usta

Njemačka

Jenapharm Gmbh & Co Kg

Chlormadinon Jenapharm

Chlormadinone Acetate 2 mg Tablet

tableta

kroz usta

Njemačka

Jenapharm Gmbh & Co Kg

Enriqa

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

filmom obložena tableta

kroz usta

Njemačka

Meda Pharma Gmbh & Co. Kg

Bellissima

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

filmom obložena tableta

kroz usta

Njemačka

Meda Pharma Gmbh & Co. Kg

Bellissima 21+7

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

filmom obložena tableta

kroz usta

Njemačka

Mibe Gmbh Arzneimittel

Madinette

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

filmom obložena tableta

kroz usta

Njemačka

Mylan Germany Gmbh

Lisette

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

filmom obložena tableta

kroz usta

Njemačka

Puren Pharma Gmbh & Co. Kg

Angiletta

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

filmom obložena tableta

kroz usta

Njemačka

Stadapharm Gmbh

Pink Luna

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

filmom obložena tableta

kroz usta

Njemačka

Zentiva Pharma Gmbh

Chloee

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

filmom obložena tableta

kroz usta

Grčka

Elpen Pharmaceutical Co. Inc.

Labous

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

filmom obložena tableta

kroz usta

Mađarska

Gedeon Richter Plc.

Belara

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

filmom obložena tableta

kroz usta

Italija

Gedeon Richter Plc.

Belara

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

filmom obložena tableta

kroz usta

Italija

Gedeon Richter Plc.

Lybella

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

filmom obložena tableta

kroz usta

Italija

Mylan S.P.A.

Mytulip

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

filmom obložena tableta

kroz usta

Italija

Sandoz S.P.A.

Eve

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

filmom obložena tableta

kroz usta

Latvija

Gedeon Richter Plc.

Belara

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

filmom obložena tableta

kroz usta

Latvija

Uab Exeltis Baltics

Clormetin

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

filmom obložena tableta

kroz usta

Litva

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet

filmom obložena tableta

kroz usta

Luksemburg

Ceres Pharma Nv

Helen

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

filmom obložena tableta

kroz usta

Luksemburg

Gedeon Richter Plc.

Bellina

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

filmom obložena tableta

kroz usta

Luksemburg

Meda Pharma Gmbh & Co. Kg

Bellissima

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

filmom obložena tableta

kroz usta

Poljska

Actavis Group Ptc Ehf.

Angiletta

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

filmom obložena tableta

kroz usta

Poljska

Exeltis Poland Sp. Z O.O.

Clormetin

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

filmom obložena tableta

kroz usta

Poljska

Gedeon Richter Polska Sp. Z. O.O.

Belara

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

filmom obložena tableta

kroz usta

Poljska

Sun-Farm Sp. Z.O.O.

Madinette

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

filmom obložena tableta

kroz usta

Poljska

Symphar Sp. Z O.O.

Symbella

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

filmom obložena tableta

kroz usta

Portugal

Gedeon Richter Plc.

Belara

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

Filmom obložena tableta

kroz usta

Portugal

Gedeon Richter Plc.

Chariva

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

filmom obložena tableta

kroz usta

Portugal

Gedeon Richter Plc.

Libeli

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

filmom obložena tableta

kroz usta

Portugal

Itf Farmahealth, Produtos Farmacêuticos, Lda

Clarissa

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

filmom obložena tableta

kroz usta

Portugal

Laboratorios León Farma, S.A.

Bonae

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

filmom obložena tableta

kroz usta

Rumunjska

Gedeon Richter România S.A.

Belara

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

filmom obložena tableta

kroz usta

Rumunjska

Gedeon Richter România S.A.

Belara Continu

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

filmom obložena tableta

kroz usta

Slovačka

Exeltis Slovakia

Lydely

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

filmom obložena tableta

kroz usta

Slovačka

Gedeon Richter Plc.

Belara

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

filmom obložena tableta

kroz usta

Slovačka

Stada Arzneimittel Ag

Belissa

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

filmom obložena tableta

kroz usta

Slovenija

Gedeon Richter Plc.

Belara

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

filmom obložena tableta

kroz usta

Španjolska

Aristo Pharma Iberia, S.L.

Clormadinona/Etinilestradiol Aristo

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

filmom obložena tableta

kroz usta

Španjolska

Brill Pharma, S.L.

Elynor

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

filmom obložena tableta

kroz usta

Španjolska

Gedeon Richter Plc.

Balianca

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

filmom obložena tableta

kroz usta

Španjolska

Gedeon Richter Plc.

Balianca Diario

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

filmom obložena tableta

kroz usta

Španjolska

Gedeon Richter Plc.

Belara

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

filmom obložena tableta

kroz usta

Španjolska

Gedeon Richter Plc.

Belara Diario

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

filmom obložena tableta

kroz usta

Španjolska

Laboratorio Stada, S.L.

Clormadinona/Etinilestradiol Stadafarma

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

filmom obložena tableta

kroz usta

Španjolska

Laboratorio Stada, S.L.

Etinilestradiol/Clormadinona Stada

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

filmom obložena tableta

kroz usta

---