Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2023 to 30 June 2023

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2))

(2023/C 269/01)

— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

6.6.2023

Arexvy

Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted)

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/23/1740

Powder and suspension for suspension for injection

Pending

9.6.2023

23.6.2023

Sugammadex Piramal

sugammadex

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland

EU/1/23/1739

Solution for injection

V03AB35

28.6.2023

26.6.2023

CAMZYOS

mavacamten

Bristol Myers Squibb Pharma EEIG

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

EU/1/23/1716

Capsule, hard

C01EB

27.6.2023

26.6.2023

Opfolda

miglustat

Amicus Therapeutics Europe Limited

Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland

EU/1/23/1737

Capsule, hard

A16AX06

27.6.2023

—	Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

1.6.2023

Luminity

Lantheus EU Limited

Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare, V14 FW97, Ireland

EU/1/06/361

5.6.2023

Bimzelx

UCB Pharma S.A.

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

EU/1/21/1575

6.6.2023

5.6.2023

Slenyto

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

EU/1/18/1318

10.6.2023

5.6.2023

Vyxeos liposomal

Jazz Pharmaceuticals Ireland Ltd

5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland

EU/1/18/1308

6.6.2023

8.6.2023

Abecma

Bristol-Myers Squibb Pharma EEIG

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

EU/1/21/1539

9.6.2023

8.6.2023

Clopidogrel ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/975

12.6.2023

8.6.2023

Doptelet

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/19/1373

13.6.2023

8.6.2023

Flixabi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/16/1106

13.6.2023

8.6.2023

Kengrexal

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/15/994

9.6.2023

8.6.2023

Ondexxya

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1345

13.6.2023

8.6.2023

Oxbryta

Pfizer Europe MA EEIG

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

EU/1/21/1622

19.6.2023

8.6.2023

Rubraca

zr pharma& GmbH

Taborstrasse 1, 1020 Wien, Österreich

EU/1/17/1250

9.6.2023

8.6.2023

Sildenafil ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/09/603

15.6.2023

8.6.2023

Zoledronic acid Mylan

Mylan Pharmaceuticals Limited

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

EU/1/12/786

9.6.2023

13.6.2023

Fabrazyme

Sanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/01/188

19.6.2023

13.6.2023

Lysodren

HRA Pharma Rare Diseases

200 avenue de Paris, 92320 Chatillon, France

EU/1/04/273

14.6.2023

13.6.2023

ReFacto AF

Pfizer Europe MA EEIG

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

EU/1/99/103

14.6.2023

13.6.2023

Tasigna

Novartis Europharm Limited

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

EU/1/07/422

14.6.2023

15.6.2023

Levetiracetam Actavis

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

EU/1/11/713

19.6.2023

15.6.2023

Orphacol

THERAVIA

16 Rue Montrosier, 92200 Neuilly-sur-Seine, France

EU/1/13/870

19.6.2023

15.6.2023

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1225

16.6.2023

19.6.2023

HBVAXPRO

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/01/183

22.6.2023

19.6.2023

Modigraf

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/09/523

21.6.2023

19.6.2023

Revestive

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/12/787

24.6.2023

19.6.2023

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/697

21.6.2023

19.6.2023

Vidaza

Bristol Myers Squibb Pharma EEIG

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

EU/1/08/488

26.6.2023

19.6.2023

Votubia

Novartis Europharm Limited

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

EU/1/11/710

20.6.2023

23.6.2023

Abecma

Bristol-Myers Squibb Pharma EEIG

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

EU/1/21/1539

28.6.2023

23.6.2023

Accofil

Accord Healthcare S.L.U.

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

EU/1/14/946

26.6.2023

23.6.2023

Adakveo

Novartis Europharm Limited

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

EU/1/20/1476

26.6.2023

23.6.2023

Braftovi

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

EU/1/18/1314

28.6.2023

23.6.2023

Cimzia

UCB Pharma S.A.

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

EU/1/09/544

26.6.2023

23.6.2023

Clopidogrel Taw Pharma

Taw Pharma (Ireland) Limited

104 Lower Baggot Street, Dublin 2, Ireland

EU/1/09/559

27.6.2023

23.6.2023

Dovprela

Mylan IRE Healthcare Limited

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

EU/1/20/1437

4.7.2023

23.6.2023

Gefitinib Mylan

Mylan Pharmaceuticals Limited

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

EU/1/18/1321

26.6.2023

23.6.2023

GONAL-f

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/95/001

26.6.2023

23.6.2023

Jivi

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/18/1324

26.6.2023

23.6.2023

Lenalidomide Accord

Accord Healthcare S.L.U.

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

EU/1/18/1316

26.6.2023

23.6.2023

Mekinist

Novartis Europharm Limited

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

EU/1/14/931

26.6.2023

23.6.2023

Mektovi

Pierre Fabre Médicament

Les Cauquillous, 81500 Lavaur, France

EU/1/18/1315

28.6.2023

23.6.2023

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

26.6.2023

23.6.2023

Paxlovid

Pfizer Europe MA EEIG

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

EU/1/22/1625

26.6.2023

23.6.2023

Pelgraz

Accord Healthcare S.L.U.

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

EU/1/18/1313

26.6.2023

23.6.2023

Verzenios

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1307

26.6.2023

23.6.2023

VEYVONDI

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/18/1298

28.6.2023

23.6.2023

Ziextenzo

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1327

26.6.2023

Deferiprone Lipomed

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/18/1310

27.6.2023

26.6.2023

LIBTAYO

Regeneron Ireland Designated Activity Company (DAC)

One Warrington Place, Dublin 2, D02 HH27 Ireland

EU/1/19/1376

27.6.2023

26.6.2023

Myfenax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/438

27.6.2023

26.6.2023

OPDIVO

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

27.6.2023

26.6.2023

Retsevmo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

27.6.2023

26.6.2023

Veklury

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

27.6.2023

26.6.2023

Xevudy

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1562

27.6.2023

26.6.2023

Zelboraf

Roche Registration GmbH

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

EU/1/12/751

27.6.2023

29.6.2023

AFSTYLA

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/16/1158

4.7.2023

29.6.2023

ARIKAYCE liposomal

Insmed Netherlands B.V.

Stadsplateau 7, 3521 AZ Utrecht, Nederland

EU/1/20/1469

30.6.2023

29.6.2023

Azacitidine Mylan

Mylan Ireland Limited

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

EU/1/20/1426

30.6.2023

29.6.2023

Beovu

Novartis Europharm Limited

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

EU/1/19/1417

30.6.2023

29.6.2023

Bydureon

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/696

30.6.2023

29.6.2023

Clopidogrel Krka d.d.

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

3.7.2023

29.6.2023

Daurismo

Pfizer Europe MA EEIG

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

EU/1/20/1451

30.6.2023

29.6.2023

Efmody

Diurnal Europe B.V.

Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland

EU/1/21/1549

3.7.2023

29.6.2023

Ervebo

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1392

3.7.2023

29.6.2023

JCOVDEN

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

30.6.2023

29.6.2023

Lenalidomide Mylan

Mylan Ireland Limited

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

EU/1/20/1490

30.6.2023

29.6.2023

Mysildecard

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/16/1134

30.6.2023

29.6.2023

Opsumit

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/893

30.6.2023

29.6.2023

Sildenafil Actavis

Actavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjörður, Íceland

EU/1/09/595

30.6.2023

29.6.2023

Sildenafil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/584

30.6.2023

29.6.2023

Vyepti

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/21/1599

3.7.2023

29.6.2023

Xgeva

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703

3.7.2023

— Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

8.6.2023

Lenalidomide Krka d.d.

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/20/1521

13.6.2023

— Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

29.6.2023

Eluracat

capromorelin tartrate

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/23/297

Oral solution

QH01AX90

3.7.2023

— Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

5.6.2023

Contacera

Zoetis Belgium

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

EU/2/12/144

8.6.2023

5.6.2023

GUMBOHATCH

Laboratorios Hipra, S.A.

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

EU/2/19/245

9.6.2023

5.6.2023

Purevax RCPCh

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/050

7.6.2023

8.6.2023

Cerenia

Zoetis Belgium

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

EU/2/06/062

9.6.2023

8.6.2023

Easotic

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/08/085

14.6.2023

8.6.2023

LETIFEND

LETI Pharma, S.L.U.

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

EU/2/16/195

9.6.2023

8.6.2023

Locatim

Biokema Europe

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

EU/2/99/011

9.6.2023

8.6.2023

Onsior

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/08/089

9.6.2023

8.6.2023

PREVEXXION RN

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/254

12.6.2023

8.6.2023

PREVEXXION RN+HVT+IBD

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/255

12.6.2023

8.6.2023

Proteq West Nile

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/11/129

14.6.2023

8.6.2023

Purevax RCP

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/052

12.6.2023

8.6.2023

Purevax RCP FeLV

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/048

12.6.2023

16.6.2023

Improvac

Zoetis Belgium

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

EU/2/09/095

20.6.2023

26.6.2023

Chanaxin

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/22/283

29.6.2023

26.6.2023

Melovem

Dopharma Research B.V.

Zalmweg 24, 4941 VX Raamsdonksveer, Nederland

EU/2/09/098

29.6.2023

Hiprabovis IBR Marker Live

Laboratorios Hipra, S.A.

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

EU/2/10/114

3.7.2023

29.6.2023

Naxcel

Zoetis Belgium SA

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

EU/2/05/053

3.7.2023

29.6.2023

Nobivac L4

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/12/143

30.6.2023

29.6.2023

Simparica

Zoetis Belgium

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

EU/2/15/191

4.7.2023

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

(1) OJ L 136, 30.4.2004, p. 1.

(2) OJ L 4, 7.1.2019, p. 43.