Sintesi delle decisioni dell'Unione europea relative alle autorizzazioni all'immissione in commercio di medicinali dal 1o febbraio 2024 al 29 febbraio 2024

[pubblicate a norma dell'articolo 13 o dell'articolo 38 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio (1) o Articolo 5 del regolamento (UE) 2019/6 del Parlamento europeo e del Consiglio (2)]

(C/2024/2197)

— Rilascio di un'autorizzazione all'immissione in commercio [articolo 13 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio]: Accettate

Data della decisione

Denominazione del medicinale

DCI (denominazione comune internazionale)

Titolare dell'autorizzazione all'immissione in commercio

Numero d'iscrizione nel registro comunitario

Forma farmaceutica

Codice ATC (anatomico, terapeutico e chimico)

Data di notifica

9.2.2024

Casgevy

exagamglogene autotemcel

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

EU/1/23/1787

Dispersione per infusione

B06AX

12.2.2024

9.2.2024

Mevlyq

eribulina

YES Pharmaceutical Development Services GmbH

Basler Strasse 7, 61352 Bad Homburg, Deutschland

EU/1/23/1789

Soluzione iniettabile

L01XX41

13.2.2024

9.2.2024

Skyclarys

omaveloxolone

Reata Ireland Limited

Block A, George's Quay Plaza, George's Quay, Dublin 2, D02 E440, Ireland

EU/1/23/1786

Capsula rigida

Pending

12.2.2024

16.2.2024

Ibuprofene Gen.Orph

ibuprofene

Gen.Orph

185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France

EU/1/23/1791

Soluzione iniettabile

C01EB16

21.2.2024

16.2.2024

Pomalidomide Viatris

pomalidomide

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/23/1785

Capsula rigida

L04AX06

19.2.2024

16.2.2024

Velsipity

etrasimod

Pfizer Europe MA EEIG

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

EU/1/23/1790

Compressa rivestita con film

L04AE05

19.2.2024

Dabigatran etexilate Leon Farma

dabigatran etexilato

Laboratorios Leon Farma S.A.

C/ La Vallina s/n, Poligono Industrial Navatejera, 24193 Villaquilambre León, España

EU/1/23/1769

Capsula rigida

B01AE07

21.2.2024

22.2.2024

Holoclar

Cellule autologhe espanse ex vivo dell'epitelio corneale umano contenenti cellule staminali

Holostem S.r.l.

Via Glauco Gottardi 100, 41125 Modena, Italia

EU/1/14/987

Tessuto vivente da coltura di cellule

S01XA19

23.2.2024

— Modifica di un'autorizzazione all'immissione in commercio [articolo 13 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio]: Accettate

Data della decisione

Denominazione del medicinale

Titolare dell'autorizzazione all'immissione in commercio

Numero d'iscrizione nel registro comunitario

Data di notifica

1.2.2024

Efavirenz Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/742

5.2.2024

1.2.2024

Hexacima

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/13/828

5.2.2024

1.2.2024

Hexyon

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/13/829

2.2.2024

1.2.2024

Inrebic

Bristol-Myers Squibb Pharma EEIG

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

EU/1/20/1514

3.2.2024

1.2.2024

Mirvaso

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

EU/1/13/904

6.2.2024

1.2.2024

Mycamine

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/08/448

5.2.2024

1.2.2024

Simponi

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546

6.2.2024

1.2.2024

Tafinlar

Novartis Europharm Limited

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

EU/1/13/865

2.2.2024

1.2.2024

Thiotepa Riemser

Esteve Pharmaceuticals GmbH

Hohenzollerndamm 150-151, 14199 Berlin, Deutschland

EU/1/21/1536

5.2.2024

1.2.2024

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

5.2.2024

6.2.2024

Abecma

Bristol-Myers Squibb Pharma EEIG

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

EU/1/21/1539

7.2.2024

6.2.2024

Cegfila

Mundipharma Corporation (Ireland) Limited

United Drug House Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland

EU/1/19/1409

7.2.2024

6.2.2024

Intuniv

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/15/1040

8.2.2024

6.2.2024

Keppra

UCB Pharma S.A.

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

EU/1/00/146

7.2.2024

6.2.2024

Nyxoid

Mundipharma Corporation (Ireland) Limited

United Drug House Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland

EU/1/17/1238

7.2.2024

6.2.2024

Sixmo

L. Molteni & C. dei F.lli Alitti Società di. Esercizio .S.p.A

Strada Statale 67, Loc. Granatieri, 50018 Scandicci (Firenze), Italia

EU/1/19/1369

7.2.2024

6.2.2024

SomaKit TOC

Advanced Accelerator Applications

8-10 Rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison, France

EU/1/16/1141

8.2.2024

Clopidogrel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/540

9.2.2024

8.2.2024

Coagadex

BPL Bioproducts Laboratory GmbH

Dornhofstrasse 34, 63263 Neu-Isenburg, Deutschland

EU/1/16/1087

12.2.2024

8.2.2024

Dynastat

Pfizer Europe MA EEIG

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

EU/1/02/209

9.2.2024

8.2.2024

QINLOCK

Deciphera Pharmaceuticals (Netherlands) B.V.

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

EU/1/21/1569

12.2.2024

8.2.2024

Scintimun

CIS bio international

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

EU/1/09/602

9.2.2024

8.2.2024

Vaxzevria

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

9.2.2024

8.2.2024

VidPrevtyn Beta

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/21/1580

9.2.2024

8.2.2024

Zypadhera

CHEPLAPHARM Registration GmbH

Weiler Straße 5e, 79540 Lörrach, Deutschland

EU/1/08/479

9.2.2024

8.2.2024

Zyprexa

CHEPLAPHARM Registration GmbH

Weiler Straße 5e, 79540 Lörrach, Deutschland

EU/1/96/022

9.2.2024

8.2.2024

Zyprexa Velotab

CHEPLAPHARM Registration GmbH

Weiler Straße 5e, 79540 Lörrach, Deutschland

EU/1/99/125

9.2.2024

Clopidogrel Krka d.d.

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

12.2.2024

9.2.2024

Doptelet

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/19/1373

14.2.2024

9.2.2024

DuoPlavin

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

12.2.2024

9.2.2024

Esperoct

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/19/1374

12.2.2024

9.2.2024

Protopic

Leo Pharma A/S

Industriparken 55, 2750 Ballerup, Danmark

EU/1/02/201

13.2.2024

9.2.2024

Rasilez

Noden Pharma DAC

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

EU/1/07/405

12.2.2024

9.2.2024

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

12.2.2024

9.2.2024

Viagra

Upjohn EESV

Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland

EU/1/98/077

15.2.2024

16.2.2024

Arixtra

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/02/206

19.2.2024

16.2.2024

Azopt

Novartis Europharm Limited

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

EU/1/00/129

19.2.2024

16.2.2024

Baqsimi

Amphastar France Pharmaceuticals

Usine Saint Charles, Eragny Sur Epte, 60590 France

EU/1/19/1406

20.2.2024

16.2.2024

Bylvay

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/21/1566

19.2.2024

16.2.2024

Cayston

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/09/543

19.2.2024

16.2.2024

Entyvio

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/14/923

19.2.2024

16.2.2024

Evoltra

Sanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/06/334

19.2.2024

16.2.2024

Fetcroja

Shionogi B.V.

Herengracht 464, 1017 CA, Amsterdam, Nederland

EU/1/20/1434

19.2.2024

16.2.2024

Hemlibra

Roche Registration GmbH

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

EU/1/18/1271

20.2.2024

16.2.2024

Herzuma

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1257

19.2.2024

16.2.2024

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

19.2.2024

16.2.2024

IMJUDO

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/22/1713

19.2.2024

16.2.2024

Imraldi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1216

21.2.2024

16.2.2024

Jylamvo

Therakind (Europe) Limited

Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ireland

EU/1/17/1172

27.2.2024

16.2.2024

Kaftrio

Vertex Pharmaceuticals (Ireland) Limited

Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland

EU/1/20/1468

19.2.2024

16.2.2024

Lupkynis

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/22/1678

20.2.2024

16.2.2024

LysaKare

Advanced Accelerator Applications

8-10 Rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison, France

EU/1/19/1381

19.2.2024

16.2.2024

Natpar

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/15/1078

19.2.2024

16.2.2024

Nubriveo

UCB Pharma S.A.

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

EU/1/15/1073

19.2.2024

16.2.2024

Pemazyre

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/21/1535

21.2.2024

16.2.2024

Pregabalin Accord

Accord Healthcare S.L.U.

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

EU/1/15/1027

19.2.2024

16.2.2024

Sarclisa

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1435

19.2.2024

16.2.2024

Senshio

Shionogi B.V.

Herengracht 464, 1017 CA, Amsterdam, Nederland

EU/1/14/978

19.2.2024

16.2.2024

Stayveer

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/832

19.2.2024

16.2.2024

Stocrin

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/111

19.2.2024

16.2.2024

Truvada

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/04/305

19.2.2024

16.2.2024

Viread

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/01/200

19.2.2024

16.2.2024

Vydura

Pfizer Europe MA EEIG

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

EU/1/22/1645

19.2.2024

16.2.2024

Xagrid

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/04/295

19.2.2024

22.2.2024

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

27.2.2024

22.2.2024

Docetaxel Accord

Accord Healthcare S.L.U.

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

EU/1/12/769

26.2.2024

22.2.2024

Ebvallo

Pierre Fabre Medicament

Les Cauquillous, 81500 Lavaur, France

EU/1/22/1700

26.2.2024

22.2.2024

Pravafenix

LABORATOIRES SMB SA

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

EU/1/11/679

23.2.2024

22.2.2024

Skytrofa

Ascendis Pharma Endocrinology Division A/S

Tuborg Boulevard 12, 2900 Hellerup, Danmark

EU/1/21/1607

23.2.2024

22.2.2024

Spectrila

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/15/1072

26.2.2024

22.2.2024

Strensiq

Alexion Europe SAS

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

EU/1/15/1015

26.2.2024

22.2.2024

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

23.2.2024

BLENREP

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/20/1474

29.2.2024

26.2.2024

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

28.2.2024

29.2.2024

Capecitabina medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/12/802

1.3.2024

29.2.2024

Posaconazole AHCL

Accord Healthcare S.L.U.

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

EU/1/19/1380

1.3.2024

29.2.2024

Retsevmo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

1.3.2024

29.2.2024

Tevagrastim

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/08/445

4.3.2024

29.2.2024

VidPrevtyn Beta

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/21/1580

1.3.2024

— Ritiro di un'autorizzazione all'immissione in commercio [articolo 13 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio]

Data della decisione

Denominazione del medicinale

Titolare dell'autorizzazione all'immissione in commercio

Numero d'iscrizione nel registro comunitario

Data di notifica

1.2.2024

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

EU/1/99/110

3.2.2024

9.2.2024

Apealea

Inceptua AB

Gustavslundsv. 143, 16751 Bromma, Sverige

EU/1/18/1292

14.2.2024

— Modifica di un'autorizzazione all'immissione in commercio [articolo 38 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio; Articolo 5 del regolamento (UE) 2019/6 del Parlamento europeo e del Consiglio]: Accettate

Data della decisione

Denominazione del medicinale

Titolare dell'autorizzazione all'immissione in commercio

Numero d'iscrizione nel registro comunitario

Data di notifica

1.2.2024

Solensia

Zoetis Belgium SA

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

EU/2/20/269

2.2.2024

1.2.2024

Solensia

Zoetis Belgium SA

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

EU/2/20/269

2.2.2024

1.2.2024

Zactran

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/08/082

6.2.2024

29.2.2024

Metacam

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/97/004

1.3.2024

29.2.2024

REXXOLIDE

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/20/263

6.3.2024

Per consultare la relazione pubblica di valutazione sui medicinali in questione e le correlate decisioni contattare:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

(1) GU L 136 del 30.4.2004, pag. 1.

(2) GU L 4 del 7.1.2019, pag. 43.