Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. listopada 2024. do 31. listopada 2024.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1) ili Članak 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća (2) )

(C/2024/6971)

— Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

1.10.2024.

Brinavess

Correvio

15 rue du Bicentenaire, 92800 Puteaux, France

EU/1/10/645

23.10.2024.

1.10.2024.

Champix

Pfizer Europe MA EEIG

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

EU/1/06/360

2.10.2024.

1.10.2024.

Exjade

Novartis Europharm Limited

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

EU/1/06/356

2.10.2024.

1.10.2024.

Fosavance

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/05/310

2.10.2024.

1.10.2024.

Prialt

Esteve Pharmaceuticals GmbH

Hohenzollerndamm 150-151, 14199 Berlin, Deutschland

EU/1/04/302

15.10.2024.

1.10.2024.

Senshio

Shionogi B.V.

Herengracht 464, 1017 CA, Amsterdam, Nederland

EU/1/14/978

2.10.2024.

4.10.2024.

Bortezomib Fresenius Kabi

Fresenius Kabi Deutschland GmbH

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

EU/1/19/1397

7.10.2024.

4.10.2024.

EVUSHELD

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/22/1651

7.10.2024.

4.10.2024.

Tadalafil Mylan

Mylan Pharmaceuticals Limited

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

EU/1/14/961

7.10.2024.

4.10.2024.

Tenofovir disoproxil Viatris

Viatris Limited

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

EU/1/16/1129

7.10.2024.

Elaprase

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/06/365

9.10.2024.

7.10.2024.

Isturisa

Recordati Rare Diseases

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

EU/1/19/1407

8.10.2024.

Nuvaxovid

Novavax CZ a.s.

Líbalova 2348/1, Chodov, 149 00 Praha 4, Česká republika

EU/1/21/1618

8.10.2024.

9.10.2024.

Dabigatran etexilate Teva

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

Teva GmbH

EU/1/23/1769

11.10.2024.

9.10.2024.

Emselex

pharmaand GmbH

Taborstrasse 1, 1020 Wien, Österreich

EU/1/04/294

16.10.2024.

9.10.2024.

Fuzeon

Roche Registration GmbH

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

EU/1/03/252

11.10.2024.

9.10.2024.

Ganirelix Gedeon Richter

Gedeon Richter Plc.

Gyömrői út 19-21, 1103 Budapest, Magyarország

EU/1/22/1658

11.10.2024.

9.10.2024.

Mycamine

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57, 1000 Ljubljana, Slovenija

EU/1/08/448

10.10.2024.

9.10.2024.

Pemetrexed Accord

Accord Healthcare S.L.U.

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

EU/1/15/1071

10.10.2024.

9.10.2024.

Ponvory

LABORATOIRES JUVISE PHARMACEUTICALS

149 Boulevard Bataille de Stalingrad, 69100 Villeurbanne, France

EU/1/21/1550

10.10.2024.

9.10.2024.

Revlimid

Bristol-Myers Squibb Pharma EEIG

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

EU/1/07/391

14.10.2024.

21.10.2024.

Aflunov

Seqirus S.r.l.

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

EU/1/10/658

22.10.2024.

21.10.2024.

Aripiprazole Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1009

23.10.2024.

21.10.2024.

Bortezomib Hospira

Pfizer Europe MA EEIG

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

EU/1/16/1114

22.10.2024.

21.10.2024.

Buccolam

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España

EU/1/11/709

22.10.2024.

21.10.2024.

Cholestagel

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/03/268

25.10.2024.

21.10.2024.

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

22.10.2024.

21.10.2024.

Esperoct

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/19/1374

23.10.2024.

21.10.2024.

Evrysdi

Roche Registration GmbH

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

EU/1/21/1531

22.10.2024.

21.10.2024.

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

23.10.2024.

21.10.2024.

Kirsty

Biosimilar Collaborations Ireland Limited

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

EU/1/20/1506

28.10.2024.

21.10.2024.

Lumykras

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/21/1603

22.10.2024.

21.10.2024.

Ngenla

Pfizer Europe MA EEIG

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

EU/1/21/1617

22.10.2024.

21.10.2024.

Otezla

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/14/981

22.10.2024.

21.10.2024.

Pravafenix

LABORATOIRES SMB SA

26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België

EU/1/11/679

22.10.2024.

21.10.2024.

Zavicefta

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/16/1109

22.10.2024.

21.10.2024.

Zirabev

Pfizer Europe MA EEIG

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

EU/1/18/1344

22.10.2024.

21.10.2024.

Zokinvy

TMC Pharma (EU) Limited

G24 A Arclabs Research And Innovation Centre, Setu West Campus Carriganore, Waterford, X91 XD96, Ireland

EU/1/22/1660

22.10.2024.

24.10.2024.

Dexmedetomidine Accord

Accord Healthcare S.L.U.

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

EU/1/19/1418

25.10.2024.

24.10.2024.

Fasenra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1252

25.10.2024.

24.10.2024.

Jayempi

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/21/1557

25.10.2024.

24.10.2024.

NUBEQA

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/20/1432

25.10.2024.

24.10.2024.

RINVOQ

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

28.10.2024.

24.10.2024.

Tecfidera

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/13/837

25.10.2024.

24.10.2024.

Xerava

PAION Pharma GmbH

Heussstraße 25, 52078 Aachen, Deutschland

EU/1/18/1312

25.10.2024.

Inovelon

Eisai GmbH

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

EU/1/06/378

28.10.2024.

Enhertu

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

30.10.2024.

28.10.2024.

Somavert

Pfizer Europe MA EEIG

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

EU/1/02/240

30.10.2024.

28.10.2024.

Zejula

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1235

29.10.2024.

— Povlačenje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

9.10.2024.

Pemetrexed Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1037

14.10.2024.

24.10.2024.

Clopidogrel Taw Pharma

Taw Pharma (Ireland) Limited

104 Lower Baggot Street, Dublin 2, Ireland

EU/1/09/559

25.10.2024.

24.10.2024.

GAVRETO

Blueprint Medicines (Netherlands) B.V.

Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland

EU/1/21/1555

25.10.2024.

— Obustava odobrenja za stavljanje u promet (članak 20 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

4.10.2024.

Oxbryta

Pfizer Europe MA EEIG

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

EU/1/21/1622

4.10.2024.

— Izdavanje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća; Članak 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća): Prihvaćeno

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

24.10.2024.

ArthriCox

Firokoksib

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, H62 FH90, Ireland

EU/2/24/323

Tablete za žvakanje

QM01AH90

29.10.2024.

24.10.2024.

Cirbloc M Hyo

Cjepivo za circovirus svinja i enzootsku pneumoniju svinja (inaktivirano)

Ceva-Phylaxia Co. Ltd.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/24/322

Emulzija za injekciju

QI09AL08

25.10.2024.

— Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća; Članak 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća): Prihvaćeno

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

21.10.2024.

RESPIVAC aMPV

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/24/314

22.10.2024.

24.10.2024.

LETIFEND

LETI Pharma, S.L.U.

C/ Del Sol, 5, Poligono Industrial Norte,Tres Cantos, 28760 Madrid, España

EU/2/16/195

25.10.2024.

24.10.2024.

Purevax FeLV

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/00/019

29.10.2024.

24.10.2024.

Respiporc Flu3

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/09/103

30.10.2024.

28.10.2024.

Cimalgex

Vétoquinol SA

Magny-Vernois, 70200 Lure, France

EU/2/10/119

4.11.2024.

31.10.2024.

Equilis West Nile

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/13/151

4.11.2024.

31.10.2024.

Metacam

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/97/004

5.11.2024.

31.10.2024.

NexGard Combo

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/267

5.11.2024.

31.10.2024.

Novem

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/042

6.11.2024.

31.10.2024.

YURVAC RHD

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/23/298

6.11.2024.

— Povlačenje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća; Članak 5. Uredbe (EU) 2019/6 Europskog parlamenta i Vijeća)

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

4.10.2024.

Fevaxyn Pentofel

Zoetis Belgium SA

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

EU/2/96/002

8.10.2024.

4.10.2024.

Suvaxyn Aujeszky 783 + O/W

Zoetis Belgium

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

EU/2/98/009

8.10.2024.

Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

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

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