# Den Europæiske Unions C 118/31.

| | ISSN 1977-0871 |
| --- | --- |
| Den Europæiske Unions
  Tidende | C 118 |
| | |
| Dansk udgave | Meddelelser og oplysninger | 66. årgang31. marts 2023 |

ISSN 1977-0871

Den Europæiske Unions

Tidende

C 118

Dansk udgave

Meddelelser og oplysninger

66. årgang31. marts 2023

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| Indhold | Side |
| --- | --- |
| | IV   Oplysninger |
| | OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
| | Europa-Kommissionen |
| 2023/C 118/01 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. februar 2023 til 28. februar 2023(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 |
| 2023/C 118/02 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. februar 2023 til 28. februar 2023(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) | 9 |

Indhold

Side

IV   Oplysninger

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

Europa-Kommissionen

2023/C 118/01

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. februar 2023 til 28. februar 2023(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

2023/C 118/02

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. februar 2023 til 28. februar 2023(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)

9

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

DA

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IV Oplysninger

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

Europa-Kommissionen

| 31.3.2023 | DA | Den Europæiske Unions Tidende | C 118/1 |
| --- | --- | --- | --- |

31.3.2023

DA

Den Europæiske Unions Tidende

C 118/1

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. februar 2023 til 28. februar 2023

(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))

(2023/C 118/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 15.2.2023 | Dimethyl Fumarate Accord | dimethylfumarat | Accord Healthcare S.L.U. |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

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

15.2.2023

Dimethyl Fumarate Accord

dimethylfumarat

Accord Healthcare S.L.U.

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

EU/1/22/1711

Enterokapsler, hårde

L04AX07

17.2.2023

20.2.2023

Hemgenix

etranacogene dezaparvovec

| CSL Behring GmbH |
| --- |
| D-35041 Marburg, Deutschland |

CSL Behring GmbH

D-35041 Marburg, Deutschland

EU/1/22/1715

Koncentrat till infusionsvaeske, opløsning

B06

23.2.2023

20.2.2023

IMJUDO

tremelimumab

| AstraZeneca AB |
| --- |
| Forskargatan 18, 151 85 Södertälje, Sverige |

AstraZeneca AB

Forskargatan 18, 151 85 Södertälje, Sverige

EU/1/22/1713

Koncentrat till infusionsvaeske, opløsning

L01FX20

23.2.2023

20.2.2023

Tremelimumab AstraZeneca

tremelimumab

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/22/1712

Koncentrat till infusionsvaeske, opløsning

L01FX20

21.2.2023

24.2.2023

Paxlovid

Nirmatrelvir / ritonavir

| 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

Filmovertrukket tablet

J05AE30

27.2.2023

—   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 |
| --- | --- | --- | --- | --- |
| 3.2.2023 | Ambirix | GlaxoSmithKline Biologicals S.A. |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

3.2.2023

Ambirix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/02/224

6.2.2023

3.2.2023

Bortezomib Hospira

| 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/1/16/1114

6.2.2023

3.2.2023

Copiktra

| 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/1/21/1542

17.2.2023

3.2.2023

Darunavir Mylan

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

Mylan Pharmaceuticals Limited

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

EU/1/16/1140

7.2.2023

3.2.2023

EVOTAZ

| 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/1/15/1025

6.2.2023

3.2.2023

Forxiga

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

6.2.2023

3.2.2023

Glivec

| 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/1/01/198

7.2.2023

3.2.2023

HALAVEN

| Eisai GmbH |
| --- |
| Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland |

Eisai GmbH

Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland

EU/1/11/678

8.2.2023

3.2.2023

Infanrix hexa

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/00/152

17.2.2023

3.2.2023

Invanz

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/02/216

9.2.2023

3.2.2023

KANJINTI

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/18/1281

6.2.2023

3.2.2023

Levetiracetam 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/1/11/712

6.2.2023

3.2.2023

Nimvastid

| 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/1/09/525

14.2.2023

3.2.2023

NULIBRY

| Zydus France S.A.S. |
| --- |
| Zac Les Hautes Patures, 25 Rue Des Peupliers, 92000 Nanterre, France |

Zydus France S.A.S.

Zac Les Hautes Patures, 25 Rue Des Peupliers, 92000 Nanterre, France

EU/1/22/1684

9.2.2023

3.2.2023

Orencia

| 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/1/07/389

6.2.2023

3.2.2023

Pemetrexed 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/1/15/1071

7.2.2023

3.2.2023

Quofenix

| A. Menarini — Industrie Farmaceutiche Riunite — s.r.l. |
| --- |
| Via Sette Santi 3, 50131 Florence, Italia |

A. Menarini — Industrie Farmaceutiche Riunite — s.r.l.

Via Sette Santi 3, 50131 Florence, Italia

EU/1/19/1393

8.2.2023

3.2.2023

Rasilez

| Noden Pharma DAC |
| --- |
| D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland |

Noden Pharma DAC

D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland

EU/1/07/405

13.2.2023

3.2.2023

Rixubis

| Baxalta Innovations GmbH |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/14/970

9.2.2023

3.2.2023

SCENESSE

| Clinuvel Europe Limited |
| --- |
| 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland |

Clinuvel Europe Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/14/969

7.2.2023

3.2.2023

Sivextro

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/991

6.2.2023

3.2.2023

TRISENOX

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/02/204

7.2.2023

3.2.2023

Xagrid

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland

EU/1/04/295

6.2.2023

3.2.2023

Xigduo

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

6.2.2023

6.2.2023

Ebvallo

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

Pierre Fabre Medicament

Les Cauquillous, 81500 Lavaur, France

EU/1/22/1700

7.2.2023

6.2.2023

Ebymect

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1051

7.2.2023

6.2.2023

Hefiya

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

7.2.2023

6.2.2023

Kerendia

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/21/1616

7.2.2023

6.2.2023

Tivicay

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/13/892

7.2.2023

6.2.2023

Xromi

| Nova Laboratories Ireland Limited |
| --- |
| 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland |

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland

EU/1/19/1366

13.2.2023

9.2.2023

AMGLIDIA

| AMMTeK |
| --- |
| 55 rue de Turbigo, 75003 Paris, France |

AMMTeK

55 rue de Turbigo, 75003 Paris, France

EU/1/18/1279

14.2.2023

9.2.2023

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

10.2.2023

9.2.2023

Tecentriq

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

Roche Registration GmbH

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

EU/1/17/1220

13.2.2023

15.2.2023

ASPAVELI

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

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/21/1595

17.2.2023

15.2.2023

Fulphila

| Viatris Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland |

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/18/1329

16.2.2023

15.2.2023

Hyrimoz

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1286

20.2.2023

15.2.2023

JEMPERLI

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

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1538

20.2.2023

15.2.2023

Lokelma

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

16.2.2023

15.2.2023

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

16.2.2023

15.2.2023

Pemetrexed 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/1/18/1283

20.2.2023

15.2.2023

Pregabalin Sandoz

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1011

6.3.2023

15.2.2023

Semglee

| Viatris Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland |

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/18/1270

16.2.2023

15.2.2023

Trodelvy

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/21/1592

16.2.2023

15.2.2023

Vyndaqel

| 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/1/11/717

16.2.2023

15.2.2023

Zonegran

| Amdipharm Limited |
| --- |
| 3 Burlington Road, Dublin 4, D04 RD68, IRELAND |

Amdipharm Limited

3 Burlington Road, Dublin 4, D04 RD68, IRELAND

EU/1/04/307

21.2.2023

20.2.2023

Aimovig

| 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/1/18/1293

22.2.2023

20.2.2023

Calquence

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1479

21.2.2023

20.2.2023

Tractocile

| Ferring Pharmaceuticals A/S |
| --- |
| Amager Strandvej 405, 2770 Kastrup, Danmark |

Ferring Pharmaceuticals A/S

Amager Strandvej 405, 2770 Kastrup, Danmark

EU/1/99/124

3.3.2023

20.2.2023

Triumeq

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/14/940

21.2.2023

20.2.2023

Yuflyma

| 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/1/20/1513

21.2.2023

23.2.2023

Atosiban SUN

| Sun Pharmaceutical Industries Europe BV |
| --- |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland |

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/13/852

27.2.2023

23.2.2023

Gilenya

| 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/1/11/677

24.2.2023

23.2.2023

Ivabradine 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/1/17/1190

24.2.2023

23.2.2023

Kinzalmono

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/98/091

24.2.2023

23.2.2023

Micardis

| 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/1/98/090

2.3.2023

23.2.2023

Nimenrix

| 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/1/12/767

24.2.2023

23.2.2023

Pemazyre

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

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/21/1535

24.2.2023

24.2.2023

Adcirca

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/08/476

27.2.2023

24.2.2023

Emselex

| zr pharma& GmbH |
| --- |
| Hietzinger Hauptstrasse 37, 1130 Wien, Österreich |

zr pharma& GmbH

Hietzinger Hauptstrasse 37, 1130 Wien, Österreich

EU/1/04/294

1.3.2023

24.2.2023

Febuxostat Mylan

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

Mylan Pharmaceuticals Limited

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

EU/1/17/1194

27.2.2023

24.2.2023

Pemazyre

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

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/21/1535

27.2.2023

24.2.2023

QINLOCK

| Deciphera Pharmaceuticals (Netherlands) B.V. |
| --- |
| Atrium Building Floor 4th, Strawinskylaan 3051, Amsterdam, Noord-Holland, 1077 ZX, Nederland |

Deciphera Pharmaceuticals (Netherlands) B.V.

Atrium Building Floor 4th, Strawinskylaan 3051, Amsterdam, Noord-Holland, 1077 ZX, Nederland

EU/1/21/1569

3.3.2023

24.2.2023

Rixathon

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1185

27.2.2023

24.2.2023

Riximyo

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1184

27.2.2023

24.2.2023

Ronapreve

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

Roche Registration GmbH

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

EU/1/21/1601

28.2.2023

24.2.2023

TUKYSA

| Seagen B.V. |
| --- |
| Evert van de Beekstraat 1-104, 1118CL Schiphol, Nederland |

Seagen B.V.

Evert van de Beekstraat 1-104, 1118CL Schiphol, Nederland

EU/1/20/1526

2.3.2023

24.2.2023

Wakix

| Bioprojet Pharma |
| --- |
| 9 rue Rameau, 75002 Paris, France |

Bioprojet Pharma

9 rue Rameau, 75002 Paris, France

EU/1/15/1068

27.2.2023

27.2.2023

Abilify

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

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/04/276

7.3.2023

27.2.2023

Aflunov

| Seqirus S.r.l. |
| --- |
| Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italy |

Seqirus S.r.l.

Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italy

EU/1/10/658

28.2.2023

27.2.2023

Daptomycin Hospira

| 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/1/17/1175

28.2.2023

27.2.2023

Foclivia

| Seqirus S.r.l., |
| --- |
| Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia |

Seqirus S.r.l.,

Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia

EU/1/09/577

28.2.2023

27.2.2023

NUBEQA

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/20/1432

28.2.2023

27.2.2023

Reblozyl

| 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/1/20/1452

28.2.2023

27.2.2023

Reblozyl

| 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/1/20/1452

28.2.2023

27.2.2023

Sprycel

| 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/1/06/363

28.2.2023

27.2.2023

Tecentriq

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

Roche Registration GmbH

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

EU/1/17/1220

28.2.2023

27.2.2023

Venclyxto

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

28.2.2023

27.2.2023

Voriconazole 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/1/13/835

28.2.2023

—   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 |
| --- | --- | --- | --- | --- |
| 23.2.2023 | Pregabalin Zentiva k.s | Zentiva, k.s. |
| U Kabelovny 130, 102 37 Praha 10, Česká republika |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

23.2.2023

Pregabalin Zentiva k.s

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1166

24.2.2023

—   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 |
| --- | --- | --- | --- | --- |
| 2.2.2023 | Tulissin | VIRBAC |
| 1ère avenue 2065 m LID, 06516 Carros, France |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

2.2.2023

Tulissin

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/20/252

6.2.2023

3.2.2023

Forceris

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/19/235

6.2.2023

3.2.2023

Locatim

| Biokema Europe |
| --- |
| Centre des Affaires des Lilas, 77 Avenue des Lilas, 64000 Pau, France |

Biokema Europe

Centre des Affaires des Lilas, 77 Avenue des Lilas, 64000 Pau, France

EU/2/99/011

9.2.2023

3.2.2023

Panacur AquaSol

| 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/2/11/135

7.2.2023

6.2.2023

Apoquel

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

Zoetis Belgium

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

EU/2/13/154

7.2.2023

6.2.2023

CLYNAV

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/197

7.2.2023

6.2.2023

Procox

| VETOQUINOL S.A. |
| --- |
| Magny-Vernois, 70200 Lure, France |

VETOQUINOL S.A.

Magny-Vernois, 70200 Lure, France

EU/2/11/123

8.2.2023

6.2.2023

Procox

| VETOQUINOL S.A. |
| --- |
| Magny-Vernois, 70200 Lure, France |

VETOQUINOL S.A.

Magny-Vernois, 70200 Lure, France

EU/2/11/123

7.2.2023

6.2.2023

Versican Plus DHPPi/L4R

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

Zoetis Belgium

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

EU/2/14/163

7.2.2023

9.2.2023

MiPet Easecto

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

Zoetis Belgium

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

EU/2/17/220

14.2.2023

20.2.2023

Advocate

| Bayer Animal Health GmbH |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/03/039

22.2.2023

20.2.2023

Bovela

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/14/176

22.2.2023

20.2.2023

GALLIPRANT

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/221

21.2.2023

20.2.2023

Suvaxyn Circo + MH RTU

| 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/2/15/190

23.2.2023

23.2.2023

Locatim

| Biokema Europe |
| --- |
| Centre des Affaires des Lilas, 77 Avenue des Lilas, 64000 Pau, France |

Biokema Europe

Centre des Affaires des Lilas, 77 Avenue des Lilas, 64000 Pau, France

EU/2/99/011

1.3.2023

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.

---

| 31.3.2023 | DA | Den Europæiske Unions Tidende | C 118/9 |
| --- | --- | --- | --- |

31.3.2023

DA

Den Europæiske Unions Tidende

C 118/9

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. februar 2023 til 28. februar 2023

(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))

(2023/C 118/02)

—   Udstedelse, videreførsel 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 |
| --- | --- | --- | --- | --- | --- |
| 27.2.2023 | Gelisia and associated names | timolol maleate | Se bilaget I | Se bilaget I | 27.2.2023 |
| 15.2.2023 | Rambis and associated names | ramipril/bisoprolol fumarate | Se bilaget II | Se bilaget II | 16.2.2023 |

Dato for afgørelser

Lægemidlets navn/navne

INN-navn (International Non-Proprietary Name)

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

27.2.2023

Gelisia and associated names

timolol maleate

Se bilaget I

Se bilaget I

27.2.2023

15.2.2023

Rambis and associated names

ramipril/bisoprolol fumarate

Se bilaget II

Se bilaget II

16.2.2023

---

(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 I

Fortegnelse over lægemidler og formuleringer

| Medlemsstat EU/EEA | Ansøger | Særnavn Navn | Styrke | Lægemiddelform | Indgivelsesvej | Indhold (Koncentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Frankrig | SIFI S.p.A. |
| Via Ercole Patti 36 |
| 95025 — Aci Sant’Antonio (CT) |
| Italy |

Medlemsstat EU/EEA

Ansøger

Særnavn Navn

Styrke

Lægemiddelform

Indgivelsesvej

Indhold (Koncentration)

Frankrig

SIFI S.p.A.

Via Ercole Patti 36

95025 — Aci Sant’Antonio (CT)

Italy

GENOPTOL

1 mg/g

Øjengel i enkeltdosisbeholder

Okulær anvendelse

1 mg/g

Tyskland

| SIFI S.p.A. |
| --- |
| Via Ercole Patti 36 |
| 95025 — Aci Sant’Antonio (CT) |
| Italy |

SIFI S.p.A.

Via Ercole Patti 36

95025 — Aci Sant’Antonio (CT)

Italy

Gelisia

1 mg/g

Øjengel i enkeltdosisbeholder

Okulær anvendelse

1 mg/g

Italien

| SIFI S.p.A. |
| --- |
| Via Ercole Patti 36 |
| 95025 — Aci Sant’Antonio (CT) |
| Italy |

SIFI S.p.A.

Via Ercole Patti 36

95025 — Aci Sant’Antonio (CT)

Italy

GELISIA

1 mg/g

Øjengel i enkeltdosisbeholder

Okulær anvendelse

1 mg/g

Holland

| SIFI S.p.A. |
| --- |
| Via Ercole Patti 36 |
| 95025 — Aci Sant’Antonio (CT) |
| Italy |

SIFI S.p.A.

Via Ercole Patti 36

95025 — Aci Sant’Antonio (CT)

Italy

Gelisia

1 mg/g

Øjengel i enkeltdosisbeholder

Okulær anvendelse

1 mg/g

Rumænien

| SIFI S.p.A. |
| --- |
| Via Ercole Patti 36 |
| 95025 — Aci Sant’Antonio (CT) |
| Italy |

SIFI S.p.A.

Via Ercole Patti 36

95025 — Aci Sant’Antonio (CT)

Italy

GELISIA

1 mg/g

Øjengel i enkeltdosisbeholder

Okulær anvendelse

1 mg/g

Spanien

| SIFI S.p.A. |
| --- |
| Via Ercole Patti 36 |
| 95025 — Aci Sant’Antonio (CT) |
| Italy |

SIFI S.p.A.

Via Ercole Patti 36

95025 — Aci Sant’Antonio (CT)

Italy

TIMOLOL SIFI 1 MG/G GEL OFTALMICO

1 mg/g

Øjengel i enkeltdosisbeholder

Okulær anvendelse

1 mg/g

---

BILAG II

Liste over lægemidler og præsentationer

| Medlemsstat EU/EØS | Ansøger | (Opfundet) navn | Styrke | Lægemiddelform | Administrationsvej |
| --- | --- | --- | --- | --- | --- |
| Tjekkiet | Adamed Pharma S.A. |
| ul. Mariana Adamkiewicza 6A |
| 05-152 Pieńków/Czosnów |
| Polen |

Medlemsstat EU/EØS

Ansøger

(Opfundet) navn

Styrke

Lægemiddelform

Administrationsvej

Tjekkiet

Adamed Pharma S.A.

ul. Mariana Adamkiewicza 6A

05-152 Pieńków/Czosnów

Polen

RALBIOR

2,5  mg/1,25  mg (ramipril/bisoprololfumarat)

2,5  mg/2,5  mg (ramipril/bisoprololfumarat)

5 mg/2,5  mg (ramipril/bisoprololfumarat)

5 mg/5 mg (ramipril/bisoprololfumarat)

10 mg/5 mg (ramipril/bisoprololfumarat)

10 mg/10 mg

(ramipril/bisoprololfumarat)

Kapsel, hård

Oral anvendelse

Polen

| Adamed Pharma S.A. |
| --- |
| ul. Mariana Adamkiewicza 6A |
| 05-152 Pieńków/Czosnów |
| Polen |

Adamed Pharma S.A.

ul. Mariana Adamkiewicza 6A

05-152 Pieńków/Czosnów

Polen

RAMBIS

2,5  mg/1,25  mg (ramipril/bisoprololfumarat)

2,5  mg/2,5  mg (ramipril/bisoprololfumarat)

5 mg/2,5  mg

(ramipril/bisoprololfumarat)

5 mg/5 mg (ramipril/bisoprololfumarat)

10 mg/5 mg (ramipril/bisoprololfumarat)

10 mg/10 mg (ramipril/bisoprololfumarat)

Kapsel, hård

Oral anvendelse

Slovakiske Republik

| Adamed Pharma S.A. |
| --- |
| ul. Mariana Adamkiewicza 6A |
| 05-152 Pieńków/Czosnów |
| Polen |

Adamed Pharma S.A.

ul. Mariana Adamkiewicza 6A

05-152 Pieńków/Czosnów

Polen

RALBIOR 2,5  mg/1,25  mg tvrdé kapsuly;

RALBIOR 5 mg/2,5  mg tvrdé kapsuly

RALBIOR 5 mg/2,5  mg tvrdé kapsuly;

RALBIOR 5 mg/5 mg tvrdé kapsuly;

RALBIOR 10 mg/5 mg tvrdé kapsuly;

RALBIOR 10 mg/10 mg tvrdé kapsuly

2,5  mg/1,25  mg (ramipril/bisoprololfumarat)

2,5  mg/2,5  mg (ramipril/bisoprololfumarat)

5 mg/2,5  mg (ramipril/bisoprololfumarat)

5 mg/5 mg (ramipril/bisoprololfumarat)

10 mg/5 mg (ramipril/bisoprololfumarat)

10 mg/10 mg (ramipril/bisoprololfumarat)

Kapsel, hård

Oral anvendelse

---