# Den Europæiske Unions C 331/31.

| | ISSN 1977-0871 |
| --- | --- |
| Den Europæiske Unions
  Tidende | C 331 |
| | |
| Dansk udgave | Meddelelser og oplysninger | 65. årgang31. august 2022 |

ISSN 1977-0871

Den Europæiske Unions

Tidende

C 331

Dansk udgave

Meddelelser og oplysninger

65. årgang31. august 2022

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| Indhold | Side |
| --- | --- |
| | IV   Oplysninger |
| | OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
| | Europa-Kommissionen |
| 2022/C 331/01 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juli 2022 til 31. juli 2022(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 eller artikel 5 i Europa-Parlamentets og Rådets forordning (EU) 2019/6) | 1 |
| 2022/C 331/02 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juli 2022 til 31. juli 2022(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF, artikel 38 i direktiv 2001/82/EF eller artikel 5 i Europa-Parlamentets og Rådets forordning (EU) 2019/6) | 13 |

Indhold

Side

IV   Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

2022/C 331/01

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juli 2022 til 31. juli 2022(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 eller artikel 5 i Europa-Parlamentets og Rådets forordning (EU) 2019/6)

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 eller artikel 5 i Europa-Parlamentets og Rådets forordning (EU) 2019/6)

1

2022/C 331/02

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juli 2022 til 31. juli 2022(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF, artikel 38 i direktiv 2001/82/EF eller artikel 5 i Europa-Parlamentets og Rådets forordning (EU) 2019/6)

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF, artikel 38 i direktiv 2001/82/EF eller artikel 5 i Europa-Parlamentets og Rådets forordning (EU) 2019/6)

13

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| DA | |
| --- | --- |

DA

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IV Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

| 31.8.2022 | DA | Den Europæiske Unions Tidende | C 331/1 |
| --- | --- | --- | --- |

31.8.2022

DA

Den Europæiske Unions Tidende

C 331/1

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juli 2022 til 31. juli 2022

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 (1) eller artikel 5 i Europa-Parlamentets og Rådets forordning (EU) 2019/6 (2))

(2022/C 331/01)

—   Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.7.2022 | LIBTAYO | cemiplimab | Regeneron Ireland Designated Activity Company (DAC) |
| One Warrington Place, Dublin 2, D02 HH27 Ireland |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

1.7.2022

LIBTAYO

cemiplimab

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27 Ireland

EU/1/19/1376

Koncentrat til infusionsvæske, opløsning

L01XC33

5.7.2022

15.7.2022

Cevenfacta

eptacog beta (aktiveret)

| Laboratoire français du Fractionnement et des Biotechnologies |
| --- |
| Tour W, 102 Terrasse Boieldieu, 19ème Étage, 92800 Puteaux France |

Laboratoire français du Fractionnement et des Biotechnologies

Tour W, 102 Terrasse Boieldieu, 19ème Étage, 92800 Puteaux France

EU/1/22/1664

Pulver og solvens til opløsning, injektion

B02BD08

22.7.2022

15.7.2022

Ertapenem SUN

ertapenem

| Sun Pharmaceutical Industries Europe B.V. |
| --- |
| Polarisavenue 87, 2132JH Hoofddorp, Nederland |

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH Hoofddorp, Nederland

EU/1/22/1656

Pulver til koncentrat til infusionsvæske, opløsning

J01DH03

22.7.2022

15.7.2022

Ganirelix Gedeon Richter

ganirelix

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

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/22/1658

Injektionsvæske, opløsning

H01CC01

19.7.2022

15.7.2022

Kinpeygo

budesonid

| Calliditas Therapeutics AB |
| --- |
| Kungsbron 1, 11122 Stockholm, Sverige |

Calliditas Therapeutics AB

Kungsbron 1, 11122 Stockholm, Sverige

EU/1/22/1657

Kapsel med modificeret udløsning, hård

A07EA06

18.7.2022

15.7.2022

Sugammadex Fresenius Kabi

sugammadex

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/22/1663

Injektionsvæske, opløsning

V03AB35

18.7.2022

18.7.2022

NEXPOVIO

selinexor

| Karyopharm Europe GmbH |
| --- |
| Franziska-Bilek-Weg 9, 80339 München, Deutschland |

Karyopharm Europe GmbH

Franziska-Bilek-Weg 9, 80339 München, Deutschland

EU/1/21/1537

Filmovertrukket tablet

L01XX66

19.7.2022

18.7.2022

Upstaza

eladocagen exuparvovec

| PTC Therapeutics International Limited |
| --- |
| 70 Sir John Rogerson's Quay, Dublin 2, Ireland |

PTC Therapeutics International Limited

70 Sir John Rogerson's Quay, Dublin 2, Ireland

EU/1/22/1653

Infusionsvæske, opløsning

Pending

22.7.2022

18.7.2022

Zokinvy

lonafarnib

| EigerBio Europe Limited |
| --- |
| 1 Castlewood Avenue, Rathmines, Dublin 6, D06 H685, Ireland |

EigerBio Europe Limited

1 Castlewood Avenue, Rathmines, Dublin 6, D06 H685, Ireland

EU/1/22/1660

Kapsler, hårde

A16AX20

19.7.2022

22.7.2022

Sitagliptin/Metformin hydrochloride Accord

sitagliptin/metformin hydrochloride

| 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/1/22/1661

Filmovertrukket tablet

A10BD07

28.7.2022

—   Ændring af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 1.7.2022 | Armisarte | Actavis Group PTC ehf. |
| Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

1.7.2022

Armisarte

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/15/1063

6.7.2022

1.7.2022

Entecavir Accord

| 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/1/17/1211

4.7.2022

1.7.2022

Hetlioz

| Vanda Pharmaceuticals Netherlands B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland |

Vanda Pharmaceuticals Netherlands B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/15/1008

8.8.2022

1.7.2022

Irbesartan / Hydrochlorthiazid Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

4.7.2022

1.7.2022

Kinzalkomb

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/214

5.7.2022

1.7.2022

Levodopa/Carbidopa/Entacapone Orion

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/706

11.7.2022

1.7.2022

Neparvis

| 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/1/16/1103

7.7.2022

1.7.2022

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

1.7.2022

1.7.2022

Orladeyo

| Biocryst Ireland Limited |
| --- |
| Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland |

Biocryst Ireland Limited

Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland

EU/1/21/1544

5.7.2022

1.7.2022

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

1.7.2022

1.7.2022

Strensiq

| Alexion Europe SAS |
| --- |
| 103-105 rue Anatole France, 92300 Levallois-Perret, France |

Alexion Europe SAS

103-105 rue Anatole France, 92300 Levallois-Perret, France

EU/1/15/1015

4.7.2022

1.7.2022

Viramune

| 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/1/97/055

19.7.2022

1.7.2022

Zirabev

| 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/1/18/1344

4.7.2022

4.7.2022

Prialt

| Esteve Pharmaceuticals GmbH |
| --- |
| Hohenzollerndamm 150-151, 14199 Berlin, Deutschland |

Esteve Pharmaceuticals GmbH

Hohenzollerndamm 150-151, 14199 Berlin, Deutschland

EU/1/04/302

7.7.2022

8.7.2022

Amsparity

| 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/1/19/1415

12.7.2022

8.7.2022

AUBAGIO

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/13/838

11.7.2022

8.7.2022

Azacitidine Betapharm

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95, 86156 Augsburg, Deutschland |

betapharm Arzneimittel GmbH

Kobelweg 95, 86156 Augsburg, Deutschland

EU/1/19/1416

12.7.2022

8.7.2022

Azacitidine Mylan

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

Mylan Ireland Limited

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

EU/1/20/1426

12.7.2022

8.7.2022

Calquence

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1479

11.7.2022

8.7.2022

Dexdor

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

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/718

11.7.2022

8.7.2022

EDURANT

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/736

12.7.2022

8.7.2022

Efmody

| Diurnal Europe B.V. |
| --- |
| Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland |

Diurnal Europe B.V.

Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland

EU/1/21/1549

13.7.2022

8.7.2022

Eurartesim

| Alfasigma S.p.A. |
| --- |
| Via Ragazzi del '99, n.5, 40133 Bologna, Italia |

Alfasigma S.p.A.

Via Ragazzi del '99, n.5, 40133 Bologna, Italia

EU/1/11/716

12.7.2022

8.7.2022

Farydak

| Secura Bio Limited |
| --- |
| 32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland |

Secura Bio Limited

32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland

EU/1/15/1023

14.7.2022

8.7.2022

Fingolimod Accord

| 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/1/20/1450

11.7.2022

8.7.2022

Fortacin

| Recordati Ireland Ltd |
| --- |
| Raheens East, Ringaskiddy Co. Cork, Ireland |

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/13/881

12.7.2022

8.7.2022

Giapreza

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

PAION Deutschland GmbH

Heussstraße 25, 52078 Aachen, Deutschland

EU/1/19/1384

13.7.2022

8.7.2022

Grasustek

| Juta Pharma GmbH |
| --- |
| Gutenbergstr. 13, 24941, Flensburg, Deutschland |

Juta Pharma GmbH

Gutenbergstr. 13, 24941, Flensburg, Deutschland

EU/1/19/1375

12.7.2022

8.7.2022

Herceptin

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/00/145

11.7.2022

8.7.2022

Iclusig

| Incyte Biosciences Distribution B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/13/839

15.7.2022

8.7.2022

INCRELEX

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/07/402

12.7.2022

8.7.2022

Kadcyla

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/13/885

11.7.2022

8.7.2022

Keppra

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/00/146

12.7.2022

8.7.2022

Lenalidomide Mylan

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

Mylan Ireland Limited

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

EU/1/20/1490

11.7.2022

8.7.2022

Lutathera

| Advanced Accelerator Applications |
| --- |
| 20 rue Diesel, 01630 Saint-Genis-Pouilly, France |

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/17/1226

11.7.2022

8.7.2022

Mabthera

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/98/067

11.7.2022

8.7.2022

MicardisPlus

| 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/1/02/213

13.7.2022

8.7.2022

Minjuvi

| Incyte Biosciences Distribution B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/21/1570

11.7.2022

8.7.2022

Mvasi

| Amgen Technology (Ireland) UC |
| --- |
| Pottery Road, Dun Laoghaire, Co. Dublin, Ireland |

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

12.7.2022

8.7.2022

Orgovyx

| 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/1/22/1642

11.7.2022

8.7.2022

Palforzia

| Aimmune Therapeutics Ireland Limited |
| --- |
| Block B, The Crescent Building, Northwood Crescent Northwood, Dublin 9, D09 C6X8 Ireland |

Aimmune Therapeutics Ireland Limited

Block B, The Crescent Building, Northwood Crescent Northwood, Dublin 9, D09 C6X8 Ireland

EU/1/20/1495

12.7.2022

8.7.2022

Pemetrexed Sandoz

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1037

12.7.2022

8.7.2022

Quinsair

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, 43122 Parma, Italia |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/973

13.7.2022

8.7.2022

Striascan

| CIS bio international |
| --- |
| RN 306 — Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex, France |

CIS bio international

RN 306 — Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex, France

EU/1/19/1372

11.7.2022

8.7.2022

Tepadina

| ADIENNE S.r.l.S.U. |
| --- |
| Via Galileo Galilei 19, 20867 Caponago (MB), Italia |

ADIENNE S.r.l.S.U.

Via Galileo Galilei 19, 20867 Caponago (MB), Italia

EU/1/10/622

12.7.2022

8.7.2022

Thiotepa Riemser

| Esteve Pharmaceuticals GmbH |
| --- |
| Hohenzollerndamm 150-151, 14199 Berlin, Deutschland |

Esteve Pharmaceuticals GmbH

Hohenzollerndamm 150-151, 14199 Berlin, Deutschland

EU/1/21/1536

11.7.2022

8.7.2022

Tracleer

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/02/220

11.7.2022

8.7.2022

Vimpat

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/08/470

11.7.2022

8.7.2022

Votrient

| 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/1/10/628

11.7.2022

8.7.2022

Xeloda

| CHEPLAPHARM Arzneimittel GmbH |
| --- |
| Ziegelhof 24, 17489 Greifswald, Deutschland |

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/00/163

11.7.2022

8.7.2022

Xenleta

| Nabriva Therapeutics Ireland DAC |
| --- |
| Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland |

Nabriva Therapeutics Ireland DAC

Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland

EU/1/20/1457

13.7.2022

8.7.2022

Yondelis

| Pharma Mar S.A. |
| --- |
| Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España |

Pharma Mar S.A.

Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España

EU/1/07/417

12.7.2022

11.7.2022

Enhertu

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

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

13.7.2022

15.7.2022

Alecensa

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/16/1169

19.7.2022

15.7.2022

AYVAKYT

| Blueprint Medicines (Netherlands) B.V. |
| --- |
| Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland |

Blueprint Medicines (Netherlands) B.V.

Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland

EU/1/20/1473

18.7.2022

15.7.2022

Edistride

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

19.7.2022

15.7.2022

Elebrato Ellipta

| GlaxoSmithKline Trading Services Limited |
| --- |
| Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1237

19.7.2022

15.7.2022

Emgality

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1330

19.7.2022

15.7.2022

Forxiga

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

19.7.2022

15.7.2022

Fotivda

| EUSA Pharma (Netherlands) B.V. |
| --- |
| Beechavenue 54, 1119PW Schiphol-Rijk, Nederland |

EUSA Pharma (Netherlands) B.V.

Beechavenue 54, 1119PW Schiphol-Rijk, Nederland

EU/1/17/1215

10.8.2022

15.7.2022

Galvus

| 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/1/07/414

18.7.2022

15.7.2022

Idefirix

| Hansa Biopharma AB |
| --- |
| P.O. Box 785, 220 07 Lund, Sverige |

Hansa Biopharma AB

P.O. Box 785, 220 07 Lund, Sverige

EU/1/20/1471

19.7.2022

15.7.2022

Jalra

| 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/1/08/485

18.7.2022

15.7.2022

Nitisinone MDK

| MendeliKABS Europe Limited |
| --- |
| Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland |

MendeliKABS Europe Limited

Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland

EU/1/17/1217

19.7.2022

15.7.2022

PecFent

| Kyowa Kirin Holdings B.V. |
| --- |
| Bloemlaan 2, 2132 NP Hoofddorp, Nederland |

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/10/644

20.7.2022

15.7.2022

Posaconazole AHCL

| 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/1/19/1380

3.8.2022

15.7.2022

Raxone

| Santhera Pharmaceuticals (Deutschland) GmbH |
| --- |
| Marie-Curie Straße 8, 79539 Lörrach, Deutschland |

Santhera Pharmaceuticals (Deutschland) GmbH

Marie-Curie Straße 8, 79539 Lörrach, Deutschland

EU/1/15/1020

2.8.2022

15.7.2022

Remsima

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/13/853

18.7.2022

15.7.2022

Trelegy Ellipta

| GlaxoSmithKline Trading Services Limited |
| --- |
| Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1236

19.7.2022

15.7.2022

Tremfya

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

19.7.2022

15.7.2022

Xiliarx

| 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/1/08/486

18.7.2022

18.7.2022

Accofil

| 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/1/14/946

8.8.2022

18.7.2022

Bortezomib Fresenius Kabi

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/19/1397

20.7.2022

18.7.2022

Cyramza

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/957

22.7.2022

18.7.2022

Darunavir Krka d.d.

| KRKA d d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1248

20.7.2022

18.7.2022

Irbesartan Zentiva

| Zentiva k.s. |
| --- |
| U kabelovny 130, 102 37 Praha 10, Česká republika |

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/06/376

19.7.2022

18.7.2022

Lenalidomide Krka

| KRKA, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/20/1519

22.7.2022

18.7.2022

Mayzent

| 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/1/19/1414

19.7.2022

18.7.2022

Suboxone

| Indivior Europe Limited |
| --- |
| 27 Windsor Place, Dublin 2, D02 DK44, Ireland |

Indivior Europe Limited

27 Windsor Place, Dublin 2, D02 DK44, Ireland

EU/1/06/359

22.7.2022

18.7.2022

Zejula

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1235

20.7.2022

19.7.2022

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

19.7.2022

22.7.2022

Fluad Tetra

| Seqirus Netherlands B.V. |
| --- |
| Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland |

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/20/1433

28.7.2022

22.7.2022

Imvanex

| Bavarian Nordic A/S |
| --- |
| Philip Heymans Allé 3, DK-2900 Hellerup, Danmark |

Bavarian Nordic A/S

Philip Heymans Allé 3, DK-2900 Hellerup, Danmark

EU/1/13/855

25.7.2022

22.7.2022

Kirsty

| 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/1/20/1506

26.7.2022

22.7.2022

Lonquex

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/856

2.8.2022

22.7.2022

Miglustat Dipharma

| Dipharma B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland |

Dipharma B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/18/1346

26.7.2022

22.7.2022

Onureg

| 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/1/21/1556

27.7.2022

22.7.2022

Rinvoq

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

25.7.2022

22.7.2022

Ryeqo

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

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/21/1565

27.7.2022

22.7.2022

Xevudy

| GlaxoSmithKline Trading Services Limited |
| --- |
| Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1562

22.7.2022

22.7.2022

Zavesca

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/02/238

26.7.2022

25.7.2022

Braftovi

| Pierre Fabre Médicament |
| --- |
| Les Cauquillous, 81500 Lavaur, France |

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

EU/1/18/1314

26.7.2022

25.7.2022

CRYSVITA

| Kyowa Kirin Holdings B.V. |
| --- |
| Bloemlaan 2, 2132 NP Hoofddorp, Nederland |

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/17/1262

28.7.2022

25.7.2022

Cyramza

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/957

27.7.2022

25.7.2022

Zerbaxa

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1032

26.7.2022

27.7.2022

BroPair Spiromax

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/21/1534

2.8.2022

27.7.2022

Flucelvax Tetra

| Seqirus Netherlands B.V. |
| --- |
| Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland |

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/18/1326

29.7.2022

27.7.2022

Fluenz Tetra

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/887

28.7.2022

27.7.2022

Phesgo

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/20/1497

29.7.2022

27.7.2022

Rinvoq

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

28.7.2022

27.7.2022

Seffalair Spiromax

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/21/1533

2.8.2022

27.7.2022

Zubsolv

| 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/1/17/1233

8.8.2022

28.7.2022

COVID-19 Vaccine (inactivated, adjuvanted) Valneva

| Valneva Austria GmbH |
| --- |
| Campus Vienna Biocenter 3, 1030 Wien, Österreich |

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/21/1624

29.7.2022

—   Tilbagekaldelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 1.7.2022 | Thymanax | Servier (Ireland) Industries Limited |
| Gorey Road, Arklow, Co. Wicklow, Ireland |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

1.7.2022

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

5.7.2022

—   Udstedelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004; artikel 5 i Europa-Parlamentets og Rådets forordning (EU) 2019/6): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 27.7.2022 | Cortaderm | Hydrocortisonaceponat | Alfasan Nederland B.V. |
| Kuipersweg 9, 3449 JA Woerden, Nederland |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

27.7.2022

Cortaderm

Hydrocortisonaceponat

Alfasan Nederland B.V.

Kuipersweg 9, 3449 JA Woerden, Nederland

EU/2/22/287

Kutan spray, opløsning

QD07AC16

29.7.2022

27.7.2022

Evanovo

Levende anticoccidial vaccine til kyllinger

| 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/2/22/284

Suspension og solvens til injektionsvæske, suspension

Pending

28.7.2022

—   Ændring af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004; artikel 5 i Europa-Parlamentets og Rådets forordning (EU) 2019/6): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 4.7.2022 | BTVPUR | Boehringer Ingelheim Vetmedica GmbH |
| 55216 Ingelheim am Rhein, Deutschland |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

4.7.2022

BTVPUR

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/10/113

5.7.2022

4.7.2022

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

5.7.2022

11.7.2022

Coliprotec F4/F18

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/202

12.7.2022

11.7.2022

HorStem

| EquiCord S.L |
| --- |
| 103-D Loeches, Polígono. Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España. |

EquiCord S.L

103-D Loeches, Polígono. Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España.

EU/2/18/226

12.7.2022

11.7.2022

Loxicom

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate, Monaghan, Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate, Monaghan, Ireland

EU/2/08/090

14.7.2022

11.7.2022

Prevomax

| Dechra Regulatory B.V. |
| --- |
| Handelsweg 25, 5531 AE Bladel, Nederland |

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/17/211

13.7.2022

11.7.2022

VEPURED

| 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/2/17/214

14.7.2022

15.7.2022

Bravecto

| 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/2/13/158

19.7.2022

15.7.2022

Cerenia

| 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/2/06/062

19.7.2022

15.7.2022

GUMBOHATCH

| 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/2/19/245

19.7.2022

15.7.2022

Nobivac L4

| 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/2/12/143

19.7.2022

15.7.2022

Suprelorin

| 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/2/07/072

19.7.2022

15.7.2022

Suvaxyn PRRS MLV

| 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/2/17/215

22.7.2022

22.7.2022

Comfortis

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/10/115

27.7.2022

22.7.2022

FRONTPRO

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/19/240

25.7.2022

22.7.2022

GALLIPRANT

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/221

27.7.2022

22.7.2022

Onsior

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/08/089

27.7.2022

22.7.2022

Vectra Felis

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/14/165

26.7.2022

22.7.2022

VEPURED

| 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/2/17/214

27.7.2022

27.7.2022

Circovac

| CEVA-Phylaxia Co. Ltd |
| --- |
| Szállás u. 5, 1107 Budapest, Magyarország |

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/07/075

29.7.2022

27.7.2022

Loxicom

| Norbrook Laboratories (Ireland) Limited |
| --- |
| Rossmore Industrial Estate, Monaghan, Ireland |

Norbrook Laboratories (Ireland) Limited

Rossmore Industrial Estate, Monaghan, Ireland

EU/2/08/090

29.7.2022

27.7.2022

Nobilis IB 4-91

| 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/2/98/006

29.7.2022

—   Tilbagekaldelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004; artikel 5 i Europa-Parlamentets og Rådets forordning (EU) 2019/6)

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 22.7.2022 | Bovilis BTV8 | Intervet International B.V. |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

22.7.2022

Bovilis BTV8

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/10/106

9.8.2022

Alle interesserede kan ved henvendelse på nedenstående adresse få tilsendt den offentlige evalueringsrapport om de pågældende lægemidler og de afgørelser, der er truffet vedrørende disse:

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

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NEDERLANDENE

---

(1)  EUT L 136 af 30.4.2004, s. 1.

(2)  EUT L 4 af 7.1.2019, s. 43.

---

| 31.8.2022 | DA | Den Europæiske Unions Tidende | C 331/13 |
| --- | --- | --- | --- |

31.8.2022

DA

Den Europæiske Unions Tidende

C 331/13

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juli 2022 til 31. juli 2022

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF (1), artikel 38 i direktiv 2001/82/EF (2) eller artikel 5 i Europa-Parlamentets og Rådets forordning (EU) 2019/6 (3))

(2022/C 331/02)

—   Udstedelse, videreførelse eller ændring af en national markedsføringstilladelse

| Dato for afgørelser | Lægemidlets navn/navne | INN-navn (International Non-Proprietary Name) | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- | --- |
| 18.7.2022 | Daruph and Anafezyn and associated names | dasatinib (anhydrous) | Se bilaget | Se bilaget | 19.7.2022 |

Dato for afgørelser

Lægemidlets navn/navne

INN-navn (International Non-Proprietary Name)

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

18.7.2022

Daruph and Anafezyn and associated names

dasatinib (anhydrous)

Se bilaget

Se bilaget

19.7.2022

---

(1)  EUT L 311 af 28.11.2001, s. 67.

(2)  EUT L 311 af 28.11.2001, s. 1.

(3)  EUT L 4 af 7.1.2019, s. 43.

---

BILAG

Liste over lægemidler og præsentationer

| Medlemsstat EU/EØS | Ansøger
  virksomhedsnavn, adresse | (Opfundet) navn | Styrke | Farmaceutisk form | Administrationsvej |
| --- | --- | --- | --- | --- | --- |
| Frankrig | Zentiva, k.s. |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Medlemsstat EU/EØS

Ansøger

virksomhedsnavn, adresse

(Opfundet) navn

Styrke

Farmaceutisk form

Administrationsvej

Frankrig

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 16 mg, comprimé pelliculé (1)

16 mg

Filmovertrukket tablet

Oral anvendelse

Frankrig

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 40 mg, comprimé pelliculé1

40 mg

Filmovertrukket tablet

Oral anvendelse

Frankrig

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 55 mg, comprimé pelliculé1

55 mg

Filmovertrukket tablet

Oral anvendelse

Frankrig

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 63 mg, comprimé pelliculé1

63 mg

Filmovertrukket tablet

Oral anvendelse

Frankrig

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 79 mg, comprimé pelliculé1

79 mg

Filmovertrukket tablet

Oral anvendelse

Frankrig

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 111 mg, comprimé pelliculé1

111 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 16 mg Filmtabletten

16 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 16 mg Filmtabletten

16 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 40 mg Filmtabletten

40 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 40 mg Filmtabletten

40 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 55 mg Filmtabletten

55 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 55 mg Filmtabletten

55 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 63 mg Filmtabletten

63 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 63 mg Filmtabletten

63 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 79 mg Filmtabletten

79 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 79 mg Filmtabletten

79 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Anafezyn 111 mg Filmtabletten

111 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Daruph 111 mg Filmtabletten

111 mg

Filmovertrukket tablet

Oral anvendelse

Ungarn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 16 mg filmtabletta

16 mg

Filmovertrukket tablet

Oral anvendelse

Ungarn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 40 mg filmtabletta

40 mg

Filmovertrukket tablet

Oral anvendelse

Ungarn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 55 mg filmtabletta

55 mg

Filmovertrukket tablet

Oral anvendelse

Ungarn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 63 mg filmtabletta

63 mg

Filmovertrukket tablet

Oral anvendelse

Ungarn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 79 mg filmtabletta

79 mg

Filmovertrukket tablet

Oral anvendelse

Ungarn

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 111 mg filmtabletta

111 mg

Filmovertrukket tablet

Oral anvendelse

Irland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 16 mg film-coated tablets

16 mg

Filmovertrukket tablet

Oral anvendelse

Irland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 40 mg film-coated tablets

40 mg

Filmovertrukket tablet

Oral anvendelse

Irland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 55 mg film-coated tablets

55 mg

Filmovertrukket tablet

Oral anvendelse

Irland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 63 mg film-coated tablets

63 mg

Filmovertrukket tablet

Oral anvendelse

Irland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 79 mg film-coated tablets

79 mg

Filmovertrukket tablet

Oral anvendelse

Irland

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn 111 mg film-coated tablets

111 mg

Filmovertrukket tablet

Oral anvendelse

Italien

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

16 mg

Filmovertrukket tablet

Oral anvendelse

Italien

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

40 mg

Filmovertrukket tablet

Oral anvendelse

Italien

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

55 mg

Filmovertrukket tablet

Oral anvendelse

Italien

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

63 mg

Filmovertrukket tablet

Oral anvendelse

Italien

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

79 mg

Filmovertrukket tablet

Oral anvendelse

Italien

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

111 mg

Filmovertrukket tablet

Oral anvendelse

Polen

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

16 mg

Filmovertrukket tablet

Oral anvendelse

Polen

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

40 mg

Filmovertrukket tablet

Oral anvendelse

Polen

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

55 mg

Filmovertrukket tablet

Oral anvendelse

Polen

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

63 mg

Filmovertrukket tablet

Oral anvendelse

Polen

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

79 mg

Filmovertrukket tablet

Oral anvendelse

Polen

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

111 mg

Filmovertrukket tablet

Oral anvendelse

Portugal

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn

16 mg

Filmovertrukket tablet

Oral anvendelse

Portugal

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn

40 mg

Filmovertrukket tablet

Oral anvendelse

Portugal

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn

55 mg

Filmovertrukket tablet

Oral anvendelse

Portugal

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn

63 mg

Filmovertrukket tablet

Oral anvendelse

Portugal

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn

79 mg

Filmovertrukket tablet

Oral anvendelse

Portugal

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn

111 mg

Filmovertrukket tablet

Oral anvendelse

Rumænien

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 16 mg comprimate filmate

16 mg

Filmovertrukket tablet

Oral anvendelse

Rumænien

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 40 mg comprimate filmate

40 mg

Filmovertrukket tablet

Oral anvendelse

Rumænien

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 55 mg comprimate filmate

55 mg

Filmovertrukket tablet

Oral anvendelse

Rumænien

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 63 mg comprimate filmate

63 mg

Filmovertrukket tablet

Oral anvendelse

Rumænien

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 79 mg comprimate filmate

79 mg

Filmovertrukket tablet

Oral anvendelse

Rumænien

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 111 mg comprimate filmate

111 mg

Filmovertrukket tablet

Oral anvendelse

Slovakiet

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 16 mg

16 mg

Filmovertrukket tablet

Oral anvendelse

Slovakiet

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 40 mg

40 mg

Filmovertrukket tablet

Oral anvendelse

Slovakiet

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 55 mg

55 mg

Filmovertrukket tablet

Oral anvendelse

Slovakiet

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 63 mg

63 mg

Filmovertrukket tablet

Oral anvendelse

Slovakiet

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 79 mg

79 mg

Filmovertrukket tablet

Oral anvendelse

Slovakiet

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph 111 mg

111 mg

Filmovertrukket tablet

Oral anvendelse

Sverige

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn

16 mg

Filmovertrukket tablet

Oral anvendelse

Sverige

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

16 mg

Filmovertrukket tablet

Oral anvendelse

Sverige

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn

40 mg

Filmovertrukket tablet

Oral anvendelse

Sverige

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

40 mg

Filmovertrukket tablet

Oral anvendelse

Sverige

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn

55 mg

Filmovertrukket tablet

Oral anvendelse

Sverige

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

55 mg

Filmovertrukket tablet

Oral anvendelse

Sverige

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn

63 mg

Filmovertrukket tablet

Oral anvendelse

Sverige

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

63 mg

Filmovertrukket tablet

Oral anvendelse

Sverige

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn

79 mg

Filmovertrukket tablet

Oral anvendelse

Sverige

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

79 mg

Filmovertrukket tablet

Oral anvendelse

Sverige

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Anafezyn

111 mg

Filmovertrukket tablet

Oral anvendelse

Sverige

| Zentiva, k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prag 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130

102 37 Prag 10

Czech Republic

Daruph

111 mg

Filmovertrukket tablet

Oral anvendelse

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(1)  Det opfundne navn er ikke accepteret af den nationale kompetente myndighed, afventer nyt forslag fra ansøgeren.

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