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Document 52022XC0930(09)

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2022 to 31 August 2022 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

PUB/2022/1108

OJ C 376, 30.9.2022, p. 1–8 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

30.9.2022   

EN

Official Journal of the European Union

C 376/1


Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2022 to 31 August 2022

(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))

(2022/C 376/01)

—   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

8.8.2022

Veklury

remdesivir

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

Concentrate for solution for infusion

Powder for concentrate for solution for infusion

J05AB16

8.8.2022

10.8.2022

Vyvgart

efgartigimod alfa

argenx BV

Industriepark-Zwijnaarde 7, 9052 Gent, België

EU/1/22/1674

Concentrate for solution for infusion

L04AA58

11.8.2022

17.8.2022

Pepaxti

melphalan flufenamide

Oncopeptides AB (publ)

Västra Trädgårdsgatan 15, 111 53 Stockholm, Sverige

EU/1/22/1669

Powder for concentrate for solution for infusion

L01AA10

18.8.2022

17.8.2022

RAYVOW

lasmiditan

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/21/1587

Film-coated tablet

N02CC

19.8.2022

17.8.2022

Sunlenca

lenacapavir

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/22/1671

Film-coated tablet

Solution for injection

J05AX31

19.8.2022

17.8.2022

VEGZELMA

bevacizumab

Celltrion Healthcare Hungary Kft.

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

EU/1/22/1667

Concentrate for solution for infusion

L01XC07

18.8.2022

23.8.2022

TECVAYLI

teclistamab

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/22/1675

Solution for injection

L01F

24.8.2022

24.8.2022

Roctavian

valoctocogene roxaparvovec

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/22/1668

Solution for infusion

Pending

25.8.2022

25.8.2022

Ranivisio

ranibizumab

Midas Pharma GmbH

Rheinstraße 49, D-55218 Ingelheim, Deutschland

EU/1/22/1673

Solution for injection

S01LA04

26.8.2022

25.8.2022

Scemblix

asciminib

Novartis Europharm Limited

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

EU/1/22/1670

Film-coated tablet

L01EA06

26.8.2022

—   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

2.8.2022

Alecensa

Roche Registration GmbH

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

EU/1/16/1169

4.8.2022

2.8.2022

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

3.8.2022

2.8.2022

Lynparza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

3.8.2022

2.8.2022

Neofordex

Laboratoires CTRS

63 rue de l'Est, 92100 Boulogne-Billancourt, France

EU/1/15/1053

24.8.2022

2.8.2022

Prialt

Esteve Pharmaceuticals GmbH

Hohenzollerndamm 150-151, 14199 Berlin, Deutschland

EU/1/04/302

3.8.2022

2.8.2022

Vaxchora

Emergent Netherlands B.V.

Strawinskylaan 411, 1077 XX Amsterdam, Nederland

EU/1/20/1423

8.8.2022

5.8.2022

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

5.8.2022

5.8.2022

Synagis

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/99/117

9.8.2022

5.8.2022

Tacforius

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/17/1244

9.8.2022

5.8.2022

Xermelo

SERB SAS

40 Avenue George V, 75008 Paris, France

EU/1/17/1224

11.8.2022

8.8.2022

Fasenra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1252

9.8.2022

8.8.2022

Vaxzevria

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

8.8.2022

12.8.2022

Arava

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/99/118

19.8.2022

12.8.2022

Bortezomib SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/16/1102

22.8.2022

12.8.2022

Brintellix

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/13/891

29.8.2022

12.8.2022

Effentora

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/441

16.8.2022

12.8.2022

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

16.8.2022

12.8.2022

Lenalidomide Krka d.d. Novo mesto

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/20/1520

6.9.2022

12.8.2022

NexoBrid

MediWound Germany GmbH

Hans-Sachs-Strasse 100, 65428 Rüsselsheim, Deutschland

EU/1/12/803

16.8.2022

12.8.2022

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

EU/1/99/110

16.8.2022

12.8.2022

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/508

1.9.2022

16.8.2022

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España

EU/1/20/1507

22.8.2022

17.8.2022

Blitzima

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1205

18.8.2022

17.8.2022

Cuprior

Orphalan

226 Boulevard Voltaire, 75011 Paris, France

EU/1/17/1199

24.8.2022

17.8.2022

Fetcroja

Shionogi B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Nederland

EU/1/20/1434

24.8.2022

17.8.2022

Mabthera

Roche Registration GmbH

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

EU/1/98/067

18.8.2022

17.8.2022

Piqray

Novartis Europharm Limited

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

EU/1/20/1455

18.8.2022

17.8.2022

Procysbi

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/13/861

18.8.2022

17.8.2022

Rixathon

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1185

22.8.2022

17.8.2022

Riximyo

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1184

22.8.2022

17.8.2022

Vemlidy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1154

19.8.2022

22.8.2022

Granupas

Eurocept International B.V.

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/896

5.9.2022

22.8.2022

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

23.8.2022

22.8.2022

Onivyde pegylated liposomal

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/16/1130

23.8.2022

22.8.2022

Ritonavir Mylan

Mylan Pharmaceuticals Limited

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

EU/1/17/1242

23.8.2022

22.8.2022

Suliqua

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/16/1157

23.8.2022

24.8.2022

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

25.8.2022

24.8.2022

Lacosamide Accord

Accord Healthcare S.L.U.

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

EU/1/17/1230

25.8.2022

24.8.2022

PREVYMIS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/17/1245

5.9.2022

24.8.2022

Ruxience

Pfizer Europe MA EEIG

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

EU/1/20/1431

25.8.2022

25.8.2022

Enhertu

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

30.8.2022

25.8.2022

Exjade

Novartis Europharm Limited

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

EU/1/06/356

26.8.2022

25.8.2022

Myozyme

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/06/333

29.8.2022

25.8.2022

VITRAKVI

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/19/1385

30.8.2022

25.8.2022

Zolgensma

Novartis Europharm Limited

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

EU/1/20/1443

26.8.2022

—   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

5.8.2022

Zalviso

FGK Representative Service GmbH

Heimeranstraße 35, 80339 München, Deutschland

EU/1/15/1042

9.8.2022

—   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

12.8.2022

Coxatab

firocoxib

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/22/286

Chewable tablet

QM01AH90

16.8.2022

—   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

2.8.2022

Bravecto

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/13/158

3.8.2022

5.8.2022

Credelio

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/206

8.8.2022

5.8.2022

Meloxidyl

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/06/070

8.8.2022

5.8.2022

Solensia

Zoetis Belgium SA

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

EU/2/20/269

8.8.2022

12.8.2022

NexGard

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/13/159

16.8.2022

12.8.2022

Prevomax

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/17/211

17.8.2022

19.8.2022

LETIFEND

LETI Pharma, S.L.U.

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

EU/2/16/195

30.8.2022

25.8.2022

Porcilis PCV ID

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/187

1.9.2022

26.8.2022

GUMBOHATCH

Laboratorios Hipra, S.A.

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

EU/2/19/245

29.8.2022

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.


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