# Eiropas Savienības C 118/2023

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 118 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 66. gadagājums2023. gada 31. marts |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 118

Izdevums latviešu valodā

Informācija un paziņojumi

66. gadagājums2023. gada 31. marts

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| Saturs | Lappuse |
| --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2023/C 118/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2023. gada 1. februāra līdz 2023. gada 28. februārim(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu vai Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 5. pantu) | 1 |
| 2023/C 118/02 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2023. gada 1. februāra līdz 2023. gada 28. februārim(Lēmumi pieņemti saskaņā ar Eiropas Parlamenta un Padomes Direktīvas 2001/83/EK 34. pantu, Eiropas Parlamenta un Padomes Direktīvas 2001/82/EK 38. pantu vai Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 5. pantu) | 9 |

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2023/C 118/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2023. gada 1. februāra līdz 2023. gada 28. februārim(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu vai Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 5. pantu)

(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu vai Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 5. pantu)

1

2023/C 118/02

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2023. gada 1. februāra līdz 2023. gada 28. februārim(Lēmumi pieņemti saskaņā ar Eiropas Parlamenta un Padomes Direktīvas 2001/83/EK 34. pantu, Eiropas Parlamenta un Padomes Direktīvas 2001/82/EK 38. pantu vai Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 5. pantu)

(Lēmumi pieņemti saskaņā ar Eiropas Parlamenta un Padomes Direktīvas 2001/83/EK 34. pantu, Eiropas Parlamenta un Padomes Direktīvas 2001/82/EK 38. pantu vai Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 5. pantu)

9

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| LV | |
| --- | --- |

LV

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IV Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

| 31.3.2023 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 118/1 |
| --- | --- | --- | --- |

31.3.2023

LV

Eiropas Savienības Oficiālais Vēstnesis

C 118/1

---

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2023. gada 1. februāra līdz 2023. gada 28. februārim

(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 (1) 13. vai 38. pantu vai Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 (2) 5. pantu)

(2023/C 118/01)

—   Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Farmaceitiskā forma | AĶT kods (Anatomiski ķīmiski terapeitiskais kods) | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 15.2.2023. | Dimethyl Fumarate Accord | dimetilfumarāta | Accord Healthcare S.L.U. |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

15.2.2023.

Dimethyl Fumarate Accord

dimetilfumarāta

Accord Healthcare S.L.U.

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

EU/1/22/1711

Zarnās šķīstošās cietās kapsulas

L04AX07

17.2.2023.

20.2.2023.

Hemgenix

etranakogēna dezaparvoveks

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

CSL Behring GmbH

D-35041 Marburg, Deutschland

EU/1/22/1715

Koncentrāts infūziju šķīduma pagatavošanai

B06

23.2.2023.

20.2.2023.

IMJUDO

tremelimumabs

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

AstraZeneca AB

Forskargatan 18, 151 85 Södertälje, Sverige

EU/1/22/1713

Koncentrāts infūziju šķīduma pagatavošanai

L01FX20

23.2.2023.

20.2.2023.

Tremelimumab AstraZeneca

tremelimumabs

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/22/1712

Koncentrāts infūziju šķīduma pagatavošanai

L01FX20

21.2.2023.

24.2.2023.

Paxlovid

Nirmatrelvīrs / ritonavīrs

| 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

Apvalkotās tabletes

J05AE30

27.2.2023.

—   Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 3.2.2023. | Ambirix | GlaxoSmithKline Biologicals S.A. |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

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.

—   Tirdzniecības atļaujas izņemšana no aprites (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants)

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 23.2.2023. | Pregabalin Zentiva k.s | Zentiva, k.s. |
| U Kabelovny 130, 102 37 Praha 10, Česká republika |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

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.

—   Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants; Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 5. pants): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 2.2.2023. | Tulissin | VIRBAC |
| 1ère avenue 2065 m LID, 06516 Carros, France |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

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.

Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:

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

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

(1)  OV L 136, 30.4.2004., 1. lpp.

(2)  OV L 4, 7.1.2019., 43. lpp.

---

| 31.3.2023 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 118/9 |
| --- | --- | --- | --- |

31.3.2023

LV

Eiropas Savienības Oficiālais Vēstnesis

C 118/9

---

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2023. gada 1. februāra līdz 2023. gada 28. februārim

(Lēmumi pieņemti saskaņā ar Eiropas Parlamenta un Padomes Direktīvas 2001/83/EK (1) 34. pantu, Eiropas Parlamenta un Padomes Direktīvas 2001/82/EK (2) 38. pantu vai Eiropas Parlamenta un Padomes Regulas (ES) 2019/6 (3) 5. pantu)

(2023/C 118/02)

—   Valsts tirdzniecības atļaujas izsniegšana, uzturēšana vai grozīšana

| Lēmuma datums | Zāļu nosaukums(-i) | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs(-i) | Attiecīgā dalībvalsts | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- |
| 27.2.2023. | Gelisia and associated names | timolol maleate | Skatīt pielikumu I | Skatīt pielikumu I | 27.2.2023. |
| 15.2.2023. | Rambis and associated names | ramipril/bisoprolol fumarate | Skatīt pielikumu II | Skatīt pielikumu II | 16.2.2023. |

Lēmuma datums

Zāļu nosaukums(-i)

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs(-i)

Attiecīgā dalībvalsts

Paziņojuma datums

27.2.2023.

Gelisia and associated names

timolol maleate

Skatīt pielikumu I

Skatīt pielikumu I

27.2.2023.

15.2.2023.

Rambis and associated names

ramipril/bisoprolol fumarate

Skatīt pielikumu II

Skatīt pielikumu II

16.2.2023.

---

(1)  OV L 311, 28.11.2001., 67. lpp.

(2)  OV L 311, 28.11.2001., 1. lpp.

(3)  OV L 4, 7.1.2019., 43. lpp.

---

I PIELIKUMS

Zāļu un to iepakojumu saraksts

| ES/EEZ dalībvalsts | Iesniedzējs | Piešķirtais nosaukums | Stiprums | Zāļu forma | Ievadīšanas veids | Saturs (koncentrācija) |
| --- | --- | --- | --- | --- | --- | --- |
| Francija | SIFI S.p.A. |
| Via Ercole Patti 36 |
| 95025 – Aci Sant’Antonio (CT) |
| Italy |

ES/EEZ dalībvalsts

Iesniedzējs

Piešķirtais nosaukums

Stiprums

Zāļu forma

Ievadīšanas veids

Saturs (koncentrācija)

Francija

SIFI S.p.A.

Via Ercole Patti 36

95025 – Aci Sant’Antonio (CT)

Italy

GENOPTOL

1 mg/g

Acu gels vienas devas iepakojumā

okulārai lietošanai

1 mg/g

Vācija

| 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

Acu gels vienas devas iepakojumā

okulārai lietošanai

1 mg/g

Itālija

| 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

Acu gels vienas devas iepakojumā

okulārai lietošanai

1 mg/g

Holande

| 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

Acu gels vienas devas iepakojumā

okulārai lietošanai

1 mg/g

Rumānija

| 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

Acu gels vienas devas iepakojumā

okulārai lietošanai

1 mg/g

Spānija

| 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

Acu gels vienas devas iepakojumā

okulārai lietošanai

1 mg/g

---

II PIELIKUMS

Zāļu nosaukumi un zāļu formas

| ES/EEZ dalībvalsts | Pretendents | (Piešķirtais) nosaukums | Stiprums | Zāļu forma | Lietošanas veids |
| --- | --- | --- | --- | --- | --- |
| Čehija | Adamed Pharma S.A. |
| ul. Mariana Adamkiewicza 6A |
| 05-152 Pieńków/Czosnów |
| Polija |

ES/EEZ dalībvalsts

Pretendents

(Piešķirtais) nosaukums

Stiprums

Zāļu forma

Lietošanas veids

Čehija

Adamed Pharma S.A.

ul. Mariana Adamkiewicza 6A

05-152 Pieńków/Czosnów

Polija

RALBIOR

2,5  mg/1,25  mg (ramiprils/bisoprolola fumarāts)

2,5  mg/2,5  mg (ramiprils/bisoprolola fumarāts)

5 mg/2,5  mg (ramiprils/bisoprolola fumarāts)

5 mg/5 mg (ramiprils/bisoprolola fumarāts)

10 mg/5 mg (ramiprils/bisoprolola fumarāts)

10 mg/10 mg

(ramiprils/bisoprolola fumarāts)

Cietā kapsula

Iekšķīgai lietošanai

Polija

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

Adamed Pharma S.A.

ul. Mariana Adamkiewicza 6A

05-152 Pieńków/Czosnów

Polija

RAMBIS

2,5  mg/1,25  mg (ramiprils/bisoprolola fumarāts)

2,5  mg/2,5  mg (ramiprils/bisoprolola fumarāts)

5 mg/2,5  mg

(ramiprils/bisoprolola fumarāts)

5 mg/5 mg (ramiprils/bisoprolola fumarāts)

10 mg/5 mg (ramiprils/bisoprolola fumarāts)

10 mg/10 mg (ramiprils/bisoprolola fumarāts)

Cietā kapsula

Iekšķīgai lietošanai

Slovākija

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

Adamed Pharma S.A.

ul. Mariana Adamkiewicza 6A

05-152 Pieńków/Czosnów

Polija

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 (ramiprils/bisoprolola fumarāts)

2,5  mg/2,5  mg (ramiprils/bisoprolola fumarāts)

5 mg/2,5  mg (ramiprils/bisoprolola fumarāts)

5 mg/5 mg (ramiprils/bisoprolola fumarāts)

10 mg/5 mg (ramiprils/bisoprolola fumarāts)

10 mg/10 mg (ramiprils/bisoprolola fumarāts)

Cietā kapsula

Iekšķīgai lietošanai

---