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Eiropas Savienības
Oficiālais Vēstnesis

LV

C sērija


C/2024/7468

30.12.2024

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2024. gada 1. novembris līdz 2024. gada 30. novembris

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

(C/2024/7468)

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

13.11.2024

Afqlir

aflibercepts

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/24/1867

Šķīdums injekcijai

S01LA05

14.11.2024

13.11.2024

Opuviz

aflibercepts

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/24/1865

Šķīdums injekcijai

S01LA05

18.11.2024

14.11.2024

ELAHERE

mirvetuksimaba soravtansīns

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/24/1866

Koncentrāts infūziju šķīduma pagatavošanai

L01FX26

15.11.2024

14.11.2024

Penbraya

A, C, W, Y grupu konjugāta un B grupas meningokoku vakcīna (rekombinanta, adsorbēta)

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/24/1871

Pulveris un suspensija injekciju suspensijas pagatavošanai

J07AH11

15.11.2024

14.11.2024

Pomalidomide Teva

Pomalidomidum

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

Teva GmbH

EU/1/24/1868

Cietās kapsulas

L04AX06

15.11.2024

15.11.2024

Fluad

Gripas vakcīna (virsmas antigēns, inaktivēts, ar adjuvantu)

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/24/1878

Suspensija injekcijai

J07BB02

19.11.2024

15.11.2024

Flucelvax

Gripas vakcīna (virsmas antigēns, inaktivēts, audzēts šūnu kultūrās)

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland

EU/1/24/1879

Suspensija injekcijai

J07BB02

26.11.2024

18.11.2024

Hympavzi

marstacimab

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/24/1874

Šķīdums injekcijai

B02BX11

19.11.2024

22.11.2024

Theralugand

lutetium (177Lu) chloridum

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Straße 10, 13125 Berlin, Deutschland

EU/1/24/1852

Radiofarmaceitisks prekursors, šķīdums

V10X

27.11.2024

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

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

4.11.2024

Dupixent

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1229

5.11.2024

4.11.2024

Farydak

pharmaand GmbH

Taborstrasse 1, 1020 Wien, Österreich

EU/1/15/1023

5.11.2024

4.11.2024

Hulio

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/18/1319

6.11.2024

4.11.2024

Inaqovi

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/23/1756

6.11.2024

4.11.2024

Remicade

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116

5.11.2024

4.11.2024

Synjardy

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1003

5.11.2024

4.11.2024

Vipdomet

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/13/843

5.11.2024

13.11.2024

Abevmy

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/20/1515

20.11.2024

13.11.2024

Eladynos

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/22/1706

14.11.2024

13.11.2024

ELREXFIO

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/23/1770

15.11.2024

13.11.2024

MenQuadfi

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1483

14.11.2024

13.11.2024

Ruxience

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/20/1431

15.11.2024

13.11.2024

TAVLESSE

Instituto Grifols, S.A.

Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espaňa

EU/1/19/1405

18.11.2024

13.11.2024

Vaxelis

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden, Nederland

EU/1/15/1079

14.11.2024

13.11.2024

Zynlonta

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/22/1695

14.11.2024

14.11.2024

Fingolimod Mylan

Mylan Pharmaceuticals Limited

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

EU/1/21/1573

15.11.2024

14.11.2024

Fulphila

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland

EU/1/18/1329

27.11.2024

14.11.2024

Givlaari

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/20/1428

19.11.2024

14.11.2024

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

15.11.2024

14.11.2024

KIMMTRAK

Immunocore Ireland Limited

Unit 1 Sky Business Centres, Unit 21 Block Port Tunnel Business Park, Clonshaugh, Dublin 17, Dublin, D17 FY82, Ireland

EU/1/22/1630

18.11.2024

14.11.2024

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/899

15.11.2024

14.11.2024

Lenalidomide Mylan

Mylan Pharmaceuticals Limited

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

EU/1/20/1490

15.11.2024

14.11.2024

Lumeblue

Cosmo Technologies Ltd

Riverside II, Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/20/1470

15.11.2024

14.11.2024

Lumykras

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/21/1603

15.11.2024

14.11.2024

Rolufta Ellipta

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1174

15.11.2024

14.11.2024

Spevigo

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/22/1688

15.11.2024

14.11.2024

Sugammadex Mylan

Mylan Pharmaceuticals Limited

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

EU/1/21/1583

15.11.2024

14.11.2024

Tarceva

CHEPLAPHARM Registration GmbH

Weiler Straße 5e, 79540 Lörrach, Deutschland

EU/1/05/311

20.11.2024

14.11.2024

Tecovirimat SIGA

SIGA Technologies Netherlands B.V.

Prinsenhil 29, Breda 4825 AX, Nederland

EU/1/21/1600

19.11.2024

14.11.2024

Uptravi

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/15/1083

15.11.2024

14.11.2024

Yescarta

Kite Pharma EU B.V.

Tufsteen 1, 2132 NT Hoofddorp, Nederland

EU/1/18/1299

15.11.2024

18.11.2024

Akynzeo

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/15/1001

19.11.2024

18.11.2024

Apixaban Accord

Accord Healthcare S.L.U.

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

EU/1/20/1458

19.11.2024

18.11.2024

Cosentyx

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/14/980

19.11.2024

18.11.2024

Erleada

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/18/1342

19.11.2024

18.11.2024

Isturisa

Recordati Rare Diseases

Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France

EU/1/19/1407

19.11.2024

18.11.2024

Krazati

Bristol Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

EU/1/23/1744

19.11.2024

18.11.2024

Lupkynis

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/22/1678

19.11.2024

18.11.2024

Nevanac

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/07/433

19.11.2024

18.11.2024

Nilemdo

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1425

27.11.2024

18.11.2024

Nustendi

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1424

27.11.2024

18.11.2024

Orgovyx

Accord Healthcare S.L.U.

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

EU/1/22/1642

19.11.2024

18.11.2024

Ozawade

Bioprojet Pharma

9 rue Rameau, 75002 Paris, France

EU/1/21/1546

19.11.2024

18.11.2024

Praluent

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/15/1031

19.11.2024

18.11.2024

Pylclari

CURIUM PET France

Biopole Clermont-Limagne, 3 rue Marie Curie, 63360 Saint-Beauzire, France

EU/1/23/1746

21.11.2024

18.11.2024

Simulect

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/98/084

19.11.2024

18.11.2024

Xolair

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/05/319

19.11.2024

19.11.2024

Victoza

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/09/529

26.11.2024

22.11.2024

Anoro Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/898

25.11.2024

22.11.2024

Beovu

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/19/1417

25.11.2024

22.11.2024

Briviact

UCB Pharma S.A.

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

EU/1/15/1073

26.11.2024

22.11.2024

Bylvay

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/21/1566

29.11.2024

22.11.2024

Cablivi

Ablynx N.V.

Technologiepark 21, 9052 Zwijnaarde, België

EU/1/18/1305

25.11.2024

22.11.2024

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1051

25.11.2024

22.11.2024

Rybelsus

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/20/1430

26.11.2024

22.11.2024

SANCUSO

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/12/766

28.11.2024

22.11.2024

Saxenda

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/15/992

26.11.2024

22.11.2024

Scintimun

CIS bio international

Boîte Postale 32, 91192 Gif-sur-Yvette, France

EU/1/09/602

27.11.2024

22.11.2024

Vaxneuvance

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/21/1591

26.11.2024

22.11.2024

Yselty

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/21/1606

25.11.2024

25.11.2024

Hepcludex

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1446

26.11.2024

25.11.2024

Kevzara

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1196

26.11.2024

25.11.2024

Kisqali

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/17/1221

26.11.2024

25.11.2024

Menveo

GSK Vaccines S.r.l.

Via Fiorentina 1, 53100 Siena, Italia

EU/1/10/614

26.11.2024

25.11.2024

Orgalutran

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/00/130

27.11.2024

25.11.2024

Supemtek

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1484

28.11.2024

25.11.2024

Tevimbra

BeiGene Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/23/1758

26.11.2024

25.11.2024

Tigecycline Accord

Accord Healthcare S.L.U.

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

EU/1/19/1394

26.11.2024

28.11.2024

Azacitidine Betapharm

betapharm Arzneimittel GmbH

Kobelweg 95, 86156 Augsburg, Deutschland

EU/1/19/1416

4.12.2024

28.11.2024

Besponsa

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/17/1200

29.11.2024

28.11.2024

Deferasirox Accord

Accord Healthcare S.L.U.

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

EU/1/19/1412

29.11.2024

28.11.2024

QUVIVIQ

Idorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Lörrach, Deutschland

EU/1/22/1638

3.12.2024

28.11.2024

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

29.11.2024

29.11.2024

Ameluz

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, 51377 Leverkusen, Deutschland

EU/1/11/740

4.12.2024

29.11.2024

Azacitidine Mylan

Mylan Ireland Limited

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

EU/1/20/1426

2.12.2024

29.11.2024

Mircera

Roche Registration GmbH

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

EU/1/07/400

3.12.2024

29.11.2024

Tasigna

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/07/422

2.12.2024

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

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

25.11.2024

Extavia

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/08/454

26.11.2024

25.11.2024

PreHevbri

VBI Vaccines B.V.

Delflandlaan 1, Queen’s Tower Office Number 714, 1062 EA Amsterdam, Nederland

EU/1/22/1641

27.11.2024

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

22.11.2024

BRAVECTO TriUNO

Fluralaners / Moksidektīns / Pirantels

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/24/325

Košļājamas tabletes

QP54AB52

28.11.2024

22.11.2024

DuOtic

Betametazona acetāts / Terbinafīns

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/24/327

Ausu gēls

QS02CA90

25.11.2024

22.11.2024

VAXXON ND CLONE

Ņūkāslas slimības dzīvā vakcīna

Vaxxinova International B.V

Transistorweg 5, 6534 AT Nijmegen,Nederland

EU/2/24/326

liofilizāts un šķīdinātājs okulonazālas suspensijas pagatavošanai vistām

QI01AD06

27.11.2024

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

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

22.11.2024

Bovilis Nasalgen-C

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/23/294

25.11.2024

22.11.2024

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/11/134

26.11.2024

22.11.2024

Poulvac Procerta HVT-IBD

Zoetis Belgium

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

EU/2/23/300

26.11.2024

25.11.2024

Eluracat

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/23/297

26.11.2024

25.11.2024

Enteroporc Coli AC

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/262

26.11.2024

25.11.2024

Mometamax Ultra

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/22/289

3.12.2024

25.11.2024

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/07/078

28.11.2024

28.11.2024

CLYNAV

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/16/197

29.11.2024

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


(1)   OV L 136, 30.4.2004, 1. lpp., ELI: https://data.europa.eu/eli/reg/2004/726/oj.

(2)   OV L 4, 7.1.2019, 43. lpp., ELI: https://data.europa.eu/eli/reg/2019/6/oj.


ELI: http://data.europa.eu/eli/C/2024/7468/oj

ISSN 1977-0952 (electronic edition)