# Il-Ġurnal Uffiċjali C 457/30 t

| | ISSN 1977-0987 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 457 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 6530 ta' Novembru 2022 |

ISSN 1977-0987

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 457

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 6530 ta' Novembru 2022

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| Werrej | Paġna |
| --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2022/C 457/01 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2022 sal-31 ta’ Ottubru 2022(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill jew l-Artikolu 5 tar-Regolament (UE) 2019/6 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| 2022/C 457/02 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2022 sal-31 ta’ Ottubru 2022(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE, l-Artikolu 38 tad-Direttiva 2001/82/KE jew l-Artikolu 5 tar-Regolament (UE) 2019/6 tal-Parlament Ewropew u tal-Kunsill) | 9 |

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

2022/C 457/01

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2022 sal-31 ta’ Ottubru 2022(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill jew l-Artikolu 5 tar-Regolament (UE) 2019/6 tal-Parlament Ewropew u tal-Kunsill)

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill jew l-Artikolu 5 tar-Regolament (UE) 2019/6 tal-Parlament Ewropew u tal-Kunsill)

1

2022/C 457/02

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2022 sal-31 ta’ Ottubru 2022(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE, l-Artikolu 38 tad-Direttiva 2001/82/KE jew l-Artikolu 5 tar-Regolament (UE) 2019/6 tal-Parlament Ewropew u tal-Kunsill)

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE, l-Artikolu 38 tad-Direttiva 2001/82/KE jew l-Artikolu 5 tar-Regolament (UE) 2019/6 tal-Parlament Ewropew u tal-Kunsill)

9

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| MT | |
| --- | --- |

MT

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IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

| 30.11.2022 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 457/1 |
| --- | --- | --- | --- |

30.11.2022

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 457/1

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Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2022 sal-31 ta’ Ottubru 2022

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill (1) jew l-Artikolu 5 tar-Regolament (UE) 2019/6 tal-Parlament Ewropew u tal-Kunsill (2))

(2022/C 457/01)

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta' notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.10.2022 | Spikevax | elasomeran | MODERNA BIOTECH SPAIN, S.L. |
| Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta' notifika

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

dispersjoni għall-injezzjoni

J07BX03

5.10.2022

10.10.2022

Comirnaty

tozinameran, Vaċċin tal-mRNA tal-COVID-19 (b’nucleoside modifikat)

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

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

dispersjoni għall-injezzjoni

Konċentrat għal dispersjoni għall-injezzjoni

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

Soluzzjoni għall-injezzjoni

J06BD08

3.11.2022

31.10.2022

Vaxzevria

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

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

Suspensjoni għall-injezzjoni

J07BX03

31.10.2022

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 3.10.2022 | Genvoya | Gilead Sciences Ireland UC |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

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

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill; L-Artikolu 5 tar-Regolament (UE) 2019/6 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 7.10.2022 | Improvac | Zoetis Belgium S.A. |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

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

Kull min jixtieq jikkonsulta r-rapport ta' evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

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

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

(1)  ĠU L 136, 30.4.04, p. 1.

(2)  ĠU L 4, 7.1.2019, p. 43.

---

| 30.11.2022 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 457/9 |
| --- | --- | --- | --- |

30.11.2022

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 457/9

---

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Ottubru 2022 sal-31 ta’ Ottubru 2022

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE (1), l-Artikolu 38 tad-Direttiva 2001/82/KE (2) jew l-Artikolu 5 tar-Regolament (UE) 2019/6 tal-Parlament Ewropew u tal-Kunsill (3))

(2022/C 457/02)

—   Ħruġ, manteniment jew modifika ta' awtorizzazzjoni għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- | --- |
| 28.10.2022 | Nomegestrol and Chlormadinone | nomegestrol or chlormadinone | Ara l-Anness | Ara l-Anness | 31.10.2022 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

28.10.2022

Nomegestrol and Chlormadinone

nomegestrol or chlormadinone

Ara l-Anness

Ara l-Anness

31.10.2022

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

(3)  ĠU L 4, 7.1.2019, p. 43.

---

ANNESS

Lista ta’ prodotti mediċinali awtorizzati fuq livell nazzjonali

Prodotti mediċinali awtorizzati fuq livell nazzjonali li fihom in-nomegestrol

| Stat Membru fiż-ŻEE | Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Isem il-prodott | INN/Sustanza attiva + qawwa | Għamla farmaċewtika | Mod ta’ amministrazzjoni |
| --- | --- | --- | --- | --- | --- |
| Il-Belġju | Ceres Pharma Nv | Nogest | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| Il-Belġju | Stragen Nordic A/S | Nomegestrol Stragen | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| Il-Belġju | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| Il-Belġju | Theramex Ireland Limited | Naemis | Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet | pillola | użu orali |
| Franza | Arrow Generiques | Nomegestrol Arrow | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| Franza | Biogaran | Nomegestrol Biogaran | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| Franza | Eg Labo Laboratoires Eurogenerics | Nomegestrol Eg | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| Franza | Mylan S.A.S | Nomegestrol Mylan | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| Franza | Sandoz | Nomegestrol Sandoz | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| Franza | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 3,75  mg Tablet | pillola | użu orali |
| Franza | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| Franza | Theramex Ireland Limited | Naemis | Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet | pillola | użu orali |
| L-Italja | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| L-Italja | Theramex Ireland Limited | Naemis | Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet | pillola | użu orali |
| Il-Lussemburgu | Ceres Pharma Nv | Nogest | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| Il-Lussemburgu | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| Il-Lussemburgu | Theramex Ireland Limited | Naemis | Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet | pillola | użu orali |
| Il-Polonja | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |
| Il-Portugall | Theramex Ireland Limited | Lutenyl | Nomegestrol Acetate 5 mg Tablet | pillola | użu orali |

Stat Membru fiż-ŻEE

Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Isem il-prodott

INN/Sustanza attiva + qawwa

Għamla farmaċewtika

Mod ta’ amministrazzjoni

Il-Belġju

Ceres Pharma Nv

Nogest

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Il-Belġju

Stragen Nordic A/S

Nomegestrol Stragen

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Il-Belġju

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Il-Belġju

Theramex Ireland Limited

Naemis

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

pillola

użu orali

Franza

Arrow Generiques

Nomegestrol Arrow

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Franza

Biogaran

Nomegestrol Biogaran

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Franza

Eg Labo Laboratoires Eurogenerics

Nomegestrol Eg

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Franza

Mylan S.A.S

Nomegestrol Mylan

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Franza

Sandoz

Nomegestrol Sandoz

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Franza

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 3,75  mg Tablet

pillola

użu orali

Franza

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Franza

Theramex Ireland Limited

Naemis

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

pillola

użu orali

L-Italja

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

L-Italja

Theramex Ireland Limited

Naemis

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

pillola

użu orali

Il-Lussemburgu

Ceres Pharma Nv

Nogest

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Il-Lussemburgu

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Il-Lussemburgu

Theramex Ireland Limited

Naemis

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

pillola

użu orali

Il-Polonja

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Il-Portugall

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

pillola

użu orali

Prodotti mediċinali awtorizzati fuq livell nazzjonali li fihom il-chlormadinone

| Stat Membru fiż-ŻEE | Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Isem il-prodott | INN/Sustanza attiva + qawwa | Għamla farmaċewtika | Il-mod ta’ amministrazzjoni |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Dermapharm Gmbh | Madinette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| L-Awstrija | Gedeon Richter Plc. | Balanca | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| L-Awstrija | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| L-Awstrija | Gynial Gmbh | Bilinda Gynial | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| L-Awstrija | Kwizda Pharma Gmbh | Delia | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Belġju | Ceres Pharma Nv | Helen | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Belġju | Gedeon Richter Plc. | Bellina | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Belġju | S.A. Meda Pharma N.V. | Orchidea | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Bulgarija | Gedeon Richter Plc. | Белара 21+7 | Chlormadinone Acetate 2 mg, Ethinylestradiol 0,03  mg | Lactose Monohydrate 94,44  mg | pillola miksija b’rita | użu orali |
| Il-Kroazja | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Kroazja | Mibe Pharmaceuticals D.O.O. | Estal | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Ir-Repubblika Ċeka | Aristo Pharma Gmbh (Art 57) | Clormetin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Ir-Repubblika Ċeka | Exeltis Czech S.R.O. | Lydely | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Ir-Repubblika Ċeka | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Ir-Repubblika Ċeka | Heaton K.S. | Flaya | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet | pillola miksija | użu orali |
| Ir-Repubblika Ċeka | Stada Arzneimittel Ag | Bonissa | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| L-Estonja | Uab Exeltis Baltics | Clormetin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol Ph. Eur. 0,03  mg Tablet | pillola miksija b’rita | orali |
| Franza | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Franza | Gedeon Richter Plc. | Belaracontinu | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | pillola miksija b’rita | użu orali |
| Franza | Mylan S.A.S | Chlormadinone Mylan | Chlormadinone Acetate 10 mg Tablet | pillola | użu orali |
| Franza | Mylan S.A.S | Chlormadinone Mylan | Chlormadinone Acetate 5 mg Tablet | pillola | użu orali |
| Franza | Sandoz | Chlormadinone Sandoz | Chlormadinone Acetate 10 mg Tablet | pillola | użu orali |
| Franza | Sandoz | Chlormadinone Sandoz | Chlormadinone Acetate 5 mg Tablet | pillola | użu orali |
| Franza | Sanofi-Aventis France | Luteran | Chlormadinone Acetate 10 mg Tablet | pillola | użu orali |
| Franza | Sanofi-Aventis France | Luteran | Chlormadinone Acetate 5 mg Tablet | pillola | użu orali |
| Franza | Teva Santé | Chlormadinone Teva | Chlormadinone Acetate 10 mg Tablet | pillola | użu orali |
| Franza | Teva Santé | Chlormadinone Teva | Chlormadinone Acetate 5 mg Tablet | pillola | użu orali |
| Il-Ġermanja | Acis Arzneimittel Gmbh | Madinance | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Aliud Pharma Gmbh | Bonita | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Aristo Pharma Gmbh (Art 57) | Lilia | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Besins Healthcare Germany Gmbh | Minette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Gedeon Richter Plc. | Balanca | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Gedeon Richter Plc. | Belara 21+7 | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Gedeon Richter Plc. | Chariva | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Gedeon Richter Plc. | Chariva 21+7 | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Gedeon Richter Plc. | Ethinylestradiol/Chlormadinonacetat 21+7 Richter | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 94,44  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Gedeon Richter Plc. | Ethinylestradiol/Chlormadinonacetat Richter | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Gedeon Richter Plc. | Neo-Eunomin | Chlormadinone Acetate 1mg Tablet, Ethinylestradiol 0,05  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Gedeon Richter Plc. | Neo-Eunomin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,05  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Hexal Ag | Mona | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Hormosan Pharma Gmbh | Solera | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Jenapharm Gmbh & Co Kg | Chlormadinon Jenapharm | Chlormadinone Acetate 2 mg Tablet | pillola | użu orali |
| Il-Ġermanja | Jenapharm Gmbh & Co Kg | Enriqa | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Meda Pharma Gmbh & Co. Kg | Bellissima | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Meda Pharma Gmbh & Co. Kg | Bellissima 21+7 | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Mibe Gmbh Arzneimittel | Madinette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Mylan Germany Gmbh | Lisette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Puren Pharma Gmbh & Co. Kg | Angiletta | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Stadapharm Gmbh | Pink Luna | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Ġermanja | Zentiva Pharma Gmbh | Chloee | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Greċja | Elpen Pharmaceutical Co. Inc. | Labous | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| L-Ungerija | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| L-Italja | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| L-Italja | Gedeon Richter Plc. | Lybella | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| L-Italja | Mylan S.P.A. | Mytulip | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| L-Italja | Sandoz S.P.A. | Eve | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Latvja | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Latvja | Uab Exeltis Baltics | Clormetin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol Ph. Eur. 0,03  mg Tablet | pillola miksija b’rita | orali |
| Il-Litwanja | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet | pillola miksija b’rita | użu orali |
| Il-Lussemburgu | Ceres Pharma Nv | Helen | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Lussemburgu | Gedeon Richter Plc. | Bellina | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Lussemburgu | Meda Pharma Gmbh & Co. Kg | Bellissima | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Polonja | Actavis Group Ptc Ehf. | Angiletta | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Polonja | Exeltis Poland Sp. Z O.O. | Clormetin | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Polonja | Gedeon Richter Polska Sp. Z. O.O. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Polonja | Sun-Farm Sp. Z.O.O. | Madinette | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Polonja | Symphar Sp. Z O.O. | Symbella | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Portugall | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Portugall | Gedeon Richter Plc. | Chariva | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Portugall | Gedeon Richter Plc. | Libeli | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Portugall | Itf Farmahealth, Produtos Farmacêuticos, Lda | Clarissa | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Il-Portugall | Laboratorios León Farma, S.A. | Bonae | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Ir-Rumanija | Gedeon Richter România S.A. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Ir-Rumanija | Gedeon Richter România S.A. | Belara Continu | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,32  mg Tablet | pillola miksija b’rita | użu orali |
| Is-Slovakkja | Exeltis Slovakia | Lydely | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Is-Slovakkja | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Is-Slovakkja | Stada Arzneimittel Ag | Belissa | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Is-Slovenja | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Spanja | Aristo Pharma Iberia, S.L. | Clormadinona/Etinilestradiol Aristo | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Spanja | Brill Pharma, S.L. | Elynor | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Spanja | Gedeon Richter Plc. | Balianca | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Spanja | Gedeon Richter Plc. | Balianca Diario | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | pillola miksija b’rita | użu orali |
| Spanja | Gedeon Richter Plc. | Belara | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Spanja | Gedeon Richter Plc. | Belara Diario | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet | pillola miksija b’rita | użu orali |
| Spanja | Laboratorio Stada, S.L. | Clormadinona/Etinilestradiol Stadafarma | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |
| Spanja | Laboratorio Stada, S.L. | Etinilestradiol/Clormadinona Stada | Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | pillola miksija b’rita | użu orali |

Stat Membru fiż-ŻEE

Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Isem il-prodott

INN/Sustanza attiva + qawwa

Għamla farmaċewtika

Il-mod ta’ amministrazzjoni

L-Awstrija

Dermapharm Gmbh

Madinette

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

pillola miksija b’rita

użu orali

L-Awstrija

Gedeon Richter Plc.

Balanca

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

pillola miksija b’rita

użu orali

L-Awstrija

Gedeon Richter Plc.

Belara

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

pillola miksija b’rita

użu orali

L-Awstrija

Gynial Gmbh

Bilinda Gynial

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

pillola miksija b’rita

użu orali

L-Awstrija

Kwizda Pharma Gmbh

Delia

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

pillola miksija b’rita

użu orali

Il-Belġju

Ceres Pharma Nv

Helen

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

pillola miksija b’rita

użu orali

Il-Belġju

Gedeon Richter Plc.

Bellina

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

pillola miksija b’rita

użu orali

Il-Belġju

S.A. Meda Pharma N.V.

Orchidea

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

pillola miksija b’rita

użu orali

Il-Bulgarija

Gedeon Richter Plc.

Белара 21+7

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

pillola miksija b’rita

użu orali

Il-Kroazja

Gedeon Richter Plc.

Belara

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

pillola miksija b’rita

użu orali

Il-Kroazja

Mibe Pharmaceuticals D.O.O.

Estal

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

pillola miksija b’rita

użu orali

Ir-Repubblika Ċeka

Aristo Pharma Gmbh (Art 57)

Clormetin

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

pillola miksija b’rita

użu orali

Ir-Repubblika Ċeka

Exeltis Czech S.R.O.

Lydely

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

pillola miksija b’rita

użu orali

Ir-Repubblika Ċeka

Gedeon Richter Plc.

Belara

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

pillola miksija b’rita

użu orali

Ir-Repubblika Ċeka

Heaton K.S.

Flaya

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet

pillola miksija

użu orali

Ir-Repubblika Ċeka

Stada Arzneimittel Ag

Bonissa

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

pillola miksija b’rita

użu orali

L-Estonja

Uab Exeltis Baltics

Clormetin

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

pillola miksija b’rita

orali

Franza

Gedeon Richter Plc.

Belara

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

pillola miksija b’rita

użu orali

Franza

Gedeon Richter Plc.

Belaracontinu

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

pillola miksija b’rita

użu orali

Franza

Mylan S.A.S

Chlormadinone Mylan

Chlormadinone Acetate 10 mg Tablet

pillola

użu orali

Franza

Mylan S.A.S

Chlormadinone Mylan

Chlormadinone Acetate 5 mg Tablet

pillola

użu orali

Franza

Sandoz

Chlormadinone Sandoz

Chlormadinone Acetate 10 mg Tablet

pillola

użu orali

Franza

Sandoz

Chlormadinone Sandoz

Chlormadinone Acetate 5 mg Tablet

pillola

użu orali

Franza

Sanofi-Aventis France

Luteran

Chlormadinone Acetate 10 mg Tablet

pillola

użu orali

Franza

Sanofi-Aventis France

Luteran

Chlormadinone Acetate 5 mg Tablet

pillola

użu orali

Franza

Teva Santé

Chlormadinone Teva

Chlormadinone Acetate 10 mg Tablet

pillola

użu orali

Franza

Teva Santé

Chlormadinone Teva

Chlormadinone Acetate 5 mg Tablet

pillola

użu orali

Il-Ġermanja

Acis Arzneimittel Gmbh

Madinance

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Aliud Pharma Gmbh

Bonita

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Aristo Pharma Gmbh (Art 57)

Lilia

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Besins Healthcare Germany Gmbh

Minette

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Gedeon Richter Plc.

Balanca

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Gedeon Richter Plc.

Belara

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Gedeon Richter Plc.

Belara 21+7

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Gedeon Richter Plc.

Chariva

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Gedeon Richter Plc.

Chariva 21+7

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Gedeon Richter Plc.

Ethinylestradiol/Chlormadinonacetat 21+7 Richter

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Gedeon Richter Plc.

Ethinylestradiol/Chlormadinonacetat Richter

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Gedeon Richter Plc.

Neo-Eunomin

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Gedeon Richter Plc.

Neo-Eunomin

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Hexal Ag

Mona

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Hormosan Pharma Gmbh

Solera

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Jenapharm Gmbh & Co Kg

Chlormadinon Jenapharm

Chlormadinone Acetate 2 mg Tablet

pillola

użu orali

Il-Ġermanja

Jenapharm Gmbh & Co Kg

Enriqa

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Meda Pharma Gmbh & Co. Kg

Bellissima

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Meda Pharma Gmbh & Co. Kg

Bellissima 21+7

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Mibe Gmbh Arzneimittel

Madinette

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Mylan Germany Gmbh

Lisette

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Puren Pharma Gmbh & Co. Kg

Angiletta

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Stadapharm Gmbh

Pink Luna

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

pillola miksija b’rita

użu orali

Il-Ġermanja

Zentiva Pharma Gmbh

Chloee

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

pillola miksija b’rita

użu orali

Il-Greċja

Elpen Pharmaceutical Co. Inc.

Labous

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

pillola miksija b’rita

użu orali

L-Ungerija

Gedeon Richter Plc.

Belara

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

pillola miksija b’rita

użu orali

L-Italja

Gedeon Richter Plc.

Belara

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

pillola miksija b’rita

użu orali

L-Italja

Gedeon Richter Plc.

Lybella

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

pillola miksija b’rita

użu orali

L-Italja

Mylan S.P.A.

Mytulip

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

pillola miksija b’rita

użu orali

L-Italja

Sandoz S.P.A.

Eve

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

pillola miksija b’rita

użu orali

Il-Latvja

Gedeon Richter Plc.

Belara

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

pillola miksija b’rita

użu orali

Il-Latvja

Uab Exeltis Baltics

Clormetin

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

pillola miksija b’rita

orali

Il-Litwanja

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet

pillola miksija b’rita

użu orali

Il-Lussemburgu

Ceres Pharma Nv

Helen

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

pillola miksija b’rita

użu orali

Il-Lussemburgu

Gedeon Richter Plc.

Bellina

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

pillola miksija b’rita

użu orali

Il-Lussemburgu

Meda Pharma Gmbh & Co. Kg

Bellissima

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

pillola miksija b’rita

użu orali

Il-Polonja

Actavis Group Ptc Ehf.

Angiletta

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

pillola miksija b’rita

użu orali

Il-Polonja

Exeltis Poland Sp. Z O.O.

Clormetin

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

pillola miksija b’rita

użu orali

Il-Polonja

Gedeon Richter Polska Sp. Z. O.O.

Belara

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

pillola miksija b’rita

użu orali

Il-Polonja

Sun-Farm Sp. Z.O.O.

Madinette

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

pillola miksija b’rita

użu orali

Il-Polonja

Symphar Sp. Z O.O.

Symbella

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

pillola miksija b’rita

użu orali

Il-Portugall

Gedeon Richter Plc.

Belara

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

pillola miksija b’rita

użu orali

Il-Portugall

Gedeon Richter Plc.

Chariva

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

pillola miksija b’rita

użu orali

Il-Portugall

Gedeon Richter Plc.

Libeli

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

pillola miksija b’rita

użu orali

Il-Portugall

Itf Farmahealth, Produtos Farmacêuticos, Lda

Clarissa

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

pillola miksija b’rita

użu orali

Il-Portugall

Laboratorios León Farma, S.A.

Bonae

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

pillola miksija b’rita

użu orali

Ir-Rumanija

Gedeon Richter România S.A.

Belara

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

pillola miksija b’rita

użu orali

Ir-Rumanija

Gedeon Richter România S.A.

Belara Continu

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

pillola miksija b’rita

użu orali

Is-Slovakkja

Exeltis Slovakia

Lydely

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

pillola miksija b’rita

użu orali

Is-Slovakkja

Gedeon Richter Plc.

Belara

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

pillola miksija b’rita

użu orali

Is-Slovakkja

Stada Arzneimittel Ag

Belissa

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

pillola miksija b’rita

użu orali

Is-Slovenja

Gedeon Richter Plc.

Belara

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

pillola miksija b’rita

użu orali

Spanja

Aristo Pharma Iberia, S.L.

Clormadinona/Etinilestradiol Aristo

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

pillola miksija b’rita

użu orali

Spanja

Brill Pharma, S.L.

Elynor

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

pillola miksija b’rita

użu orali

Spanja

Gedeon Richter Plc.

Balianca

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

pillola miksija b’rita

użu orali

Spanja

Gedeon Richter Plc.

Balianca Diario

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

pillola miksija b’rita

użu orali

Spanja

Gedeon Richter Plc.

Belara

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

pillola miksija b’rita

użu orali

Spanja

Gedeon Richter Plc.

Belara Diario

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

pillola miksija b’rita

użu orali

Spanja

Laboratorio Stada, S.L.

Clormadinona/Etinilestradiol Stadafarma

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

pillola miksija b’rita

użu orali

Spanja

Laboratorio Stada, S.L.

Etinilestradiol/Clormadinona Stada

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

pillola miksija b’rita

użu orali

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