Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2021 to 31 December 2021

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

(2022/C 50/01)

— 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

9.12.2021

Cibinqo

abrocitinib

Pfizer Europe MA EEIG

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

EU/1/21/1593

Film-coated tablet

D11AH

10.12.2021

9.12.2021

Rybrevant

amivantamab

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/21/1594

Concentrate for solution for infusion

L01FX18

10.12.2021

9.12.2021

Sitagliptin SUN

sitagliptin fumarate

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/21/1598

Film-coated tablet

A10BH01

15.12.2021

13.12.2021

ASPAVELI

pegcetacoplan

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/21/1595

Solution for infusion

L04AA54

14.12.2021

13.12.2021

Vaxneuvance

Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/21/1591

Suspension for injection

J07AL

14.12.2021

17.12.2021

Xevudy

sotrovimab

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1562

Concentrate for solution for infusion

Pending

17.12.2021

20.12.2021

Nuvaxovid

COVID-19 Vaccine (recombinant, adjuvanted)

Novavax CZ, a.s.

Bohumil 138, 281 63 Jevany, Česká republika

EU/1/21/1618

dispersion for injection

J07BX03

20.12.2021

— 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

2.12.2021

Cimzia

UCB Pharma S.A.

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

EU/1/09/544

3.12.2021

2.12.2021

Ebilfumin

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/14/915

7.12.2021

2.12.2021

Ivozall

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris, France

EU/1/19/1396

7.12.2021

2.12.2021

Kaletra

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/01/172

3.12.2021

2.12.2021

Revinty Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/929

3.12.2021

Kiovig

Baxter AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/05/329

6.12.2021

3.12.2021

Lojuxta

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/13/851

15.12.2021

3.12.2021

Naglazyme

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

11.1.2022

3.12.2021

Ocrevus

Roche Registration GmbH

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

EU/1/17/1231

6.12.2021

3.12.2021

Polivy

Roche Registration GmbH

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

EU/1/19/1388

7.12.2021

3.12.2021

Xagrid

Takeda Pharmaceuticals International AG Ireland Branch

50-58 Baggot Street Lower, Block 3 Miesian Plaza, Dublin 2, Co Dublin, D02 Y754, Ireland

EU/1/04/295

6.12.2021

RoActemra

Roche Registration GmbH

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

EU/1/08/492

7.12.2021

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

7.12.2021

8.12.2021

Spikevax

MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30, 28010 Madrid, España

EU/1/20/1507

8.12.2021

9.12.2021

ADCETRIS

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbæk Strand, Danmark

EU/1/12/794

14.12.2021

9.12.2021

AMGEVITA

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1164

13.12.2021

9.12.2021

Amyvid

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/12/805

13.12.2021

9.12.2021

Apealea

Inceptua AB

Gustavslundsv. 143, 16751 Bromma, Sverige

EU/1/18/1292

10.12.2021

9.12.2021

Chenodeoxycholic acid Leadiant

Leadiant GmbH

Liebherrstr. 22, 80538 Munich, Deutschland

EU/1/16/1110

10.12.2021

9.12.2021

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

10.12.2021

9.12.2021

Dengvaxia

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/18/1338

13.12.2021

9.12.2021

Erleada

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/18/1342

10.12.2021

9.12.2021

Esbriet

Roche Registration GmbH

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

EU/1/11/667

10.12.2021

9.12.2021

Exelon

Novartis Europharm Limited

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

EU/1/98/066

10.12.2021

9.12.2021

Holoclar

Holostem Terapie Avanzate S.r.l.

Via Glauco Gottardi 100, Modena, MO 41125, Italia

EU/1/14/987

13.12.2021

9.12.2021

JETREA

Inceptua AB

Gustavslundsv. 143, 16751 Bromma, Sverige

EU/1/13/819

10.12.2021

9.12.2021

Leganto

UCB Pharma S.A.

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

EU/1/11/695

10.12.2021

9.12.2021

Livogiva

Theramex Ireland Limited

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

EU/1/20/1462

13.12.2021

9.12.2021

Ogluo

Tetris Pharma B.V

Element Offices, Bargelaan 180-200, 2333 CW, Leiden, Nederland

EU/1/20/1523

13.12.2021

9.12.2021

Pioglitazone Accord

Accord Healthcare S.L.U.

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

EU/1/11/722

10.12.2021

9.12.2021

Pradaxa

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

14.12.2021

9.12.2021

Roteas

Berlin-Chemie AG

Glienicker Weg 125, 12489 Berlin, Deutschland

EU/1/16/1152

15.12.2021

9.12.2021

Stalevo

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/03/260

10.12.2021

9.12.2021

Thalidomide BMS

Bristol-Myers Squibb Pharma EEIG

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

EU/1/08/443

10.12.2021

9.12.2021

Xospata

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/19/1399

10.12.2021

9.12.2021

ZALTRAP

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/12/814

10.12.2021

9.12.2021

Zyprexa

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/96/022

13.12.2021

9.12.2021

Zyprexa Velotab

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/99/125

13.12.2021

ADCETRIS

Takeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/12/794

14.12.2021

13.12.2021

Conbriza

Pfizer Europe MA EEIG

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

EU/1/09/511

14.12.2021

13.12.2021

Giotrif

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/13/879

14.12.2021

13.12.2021

Invanz

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/02/216

14.12.2021

13.12.2021

Kanuma

Alexion Europe SAS

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

EU/1/15/1033

14.12.2021

13.12.2021

Kinzalmono

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/98/091

14.12.2021

13.12.2021

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

14.12.2021

13.12.2021

Neulasta

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227

15.12.2021

13.12.2021

Neuraceq

Life Radiopharma Berlin GmbH

Max-Planck-Straße 4, 12489 Berlin, Deutschland

EU/1/13/906

15.12.2021

13.12.2021

NULOJIX

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/694

14.12.2021

13.12.2021

Pramipexole Accord

Accord Healthcare S.L.U.

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

EU/1/11/728

16.12.2021

13.12.2021

Pramipexole Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/490

17.12.2021

13.12.2021

Rapiscan

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/10/643

15.12.2021

13.12.2021

Rebif

Merck Europe B.V.

Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland

EU/1/98/063

17.12.2021

13.12.2021

Rivastigmine Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/09/599

15.12.2021

13.12.2021

Thalidomide BMS

Bristol-Myers Squibb Pharma EEIG

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

EU/1/08/443

14.12.2021

13.12.2021

Xofigo

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/873

15.12.2021

16.12.2021

Ceprotin

Baxter AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/01/190

17.12.2021

16.12.2021

Cinacalcet Accordpharma

Accord Healthcare S.L.U.

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

EU/1/20/1429

17.12.2021

16.12.2021

Clopidogrel Krka d.d.

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

20.12.2021

16.12.2021

Clopidogrel Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/08/465

23.12.2021

16.12.2021

COVID-19 Vaccine Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

16.12.2021

Dexdor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/718

19.12.2021

16.12.2021

Grepid

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535

17.12.2021

16.12.2021

Herzuma

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1257

20.12.2021

16.12.2021

Humira

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

17.12.2021

16.12.2021

Jyseleca

Galapagos NV

Generaal De Wittelaan L11 A3, 2800 Mechelen Antwerp, België

EU/1/20/1480

17.12.2021

16.12.2021

KANJINTI

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/18/1281

20.12.2021

16.12.2021

Retsevmo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

20.12.2021

16.12.2021

Revestive

Shire Pharmaceuticals Ireland Limited

Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/12/787

23.12.2021

16.12.2021

Rinvoq

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

17.12.2021

16.12.2021

Sarclisa

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/20/1435

17.12.2021

16.12.2021

Siklos

Addmedica

37 rue de Caumartin, 75009 Paris, France

EU/1/07/397

17.12.2021

16.12.2021

Vemlidy

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1154

17.12.2021

16.12.2021

Vocabria

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/20/1481

17.12.2021

16.12.2021

Zoely

Theramex Ireland Limited

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

EU/1/11/690

21.12.2021

16.12.2021

Zoely

Theramex Ireland Limited

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

EU/1/11/690

21.12.2021

17.12.2021

Kineret

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/02/203

17.12.2021

20.12.2021

Intuniv

Takeda Pharmaceuticals International AG Ireland Branch

Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/15/1040

21.12.2021

20.12.2021

Nitisinone MDK

MendeliKABS Europe Limited

Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland

EU/1/17/1217

21.12.2021

20.12.2021

PANTOLOC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/519

21.12.2021

20.12.2021

Raloxifene Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/627

23.12.2021

20.12.2021

Selincro

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/12/815

21.12.2021

20.12.2021

Veklury

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/20/1459

20.12.2021

Voriconazole Hikma

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal

EU/1/15/1004

4.1.2022

— 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

13.12.2021

Leganto

UCB Pharma S.A.

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

EU/1/11/695

4.1.2022

20.12.2021

PANTOLOC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/519

21.12.2021

20.12.2021

Rasilez HCT

Noden Pharma DAC

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

EU/1/08/491

22.12.2021

20.12.2021

Ytracis

CIS bio international

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

EU/1/03/250

22.12.2021

— Issuing of a marketing authorisation (Article 38 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

7.12.2021

Imoxat

imidacloprid/moxidectin

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/21/280

Spot-on solution

QP54AB52

9.12.2021

7.12.2021

Suiseng Diff/A

Clostridioides difficile and Clostridium perfringens vaccine, inactivated

Laboratorios Hipra, S.A.

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

EU/2/21/278

Suspension for injection

QI09AB12

9.12.2021

15.12.2021

Zenalpha

medetomidine hydrochloride/vatinoxan hydrochloride

Vetcare Oy

P.O. Box 99, 24101 Salo, Suomi

EU/2/21/279

Solution for injection

QN05CM99

16.12.2021

— Modification of a marketing authorisation (Article 38 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

7.12.2021

Circovac

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/07/075

9.12.2021

7.12.2021

Stronghold Plus

Zoetis Belgium S.A.

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

EU/2/16/204

13.12.2021

Apoquel

Zoetis Belgium S.A.

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

EU/2/13/154

15.12.2021

Bravecto Plus

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/18/224

16.12.2021

15.12.2021

Cardalis

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/12/142

16.12.2021

15.12.2021

Osurnia

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/14/170

16.12.2021

15.12.2021

Rabitec

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/219

16.12.2021

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.