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Document 52023XC0131(03)

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2022 to 31 December 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/2023/87

OJ C 37, 31.1.2023, p. 1–12 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

31.1.2023   

EN

Official Journal of the European Union

C 37/1

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

(2023/C 37/01)

—   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

2.12.2022

Mycapssa

octreotide

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/22/1690

Gastro-resistant capsule, hard

H01CB02

5.12.2022

5.12.2022

Qdenga

dengue tetravalent vaccine (live, attenuated)

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/22/1699

Powder and solvent for solution for injection

J07BX04

6.12.2022

9.12.2022

Livmarli

maralixibat chloride

Mirum Pharmaceuticals International B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland

EU/1/22/1704

Oral solution

A05AX04

12.12.2022

9.12.2022

Locametz

gozetotide

Novartis Europharm Limited

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

EU/1/22/1692

Powder for solution for injection

V09IX14

12.12.2022

9.12.2022

Pemetrexed Baxter

pemetrexed

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht, Nederland

EU/1/22/1705

Powder for concentrate for solution for infusion

L01BA04

13.12.2022

9.12.2022

Pluvicto

lutetium (177Lu) vipivotide tetraxetan

Novartis Europharm Limited

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

EU/1/22/1703

Solution for injection or infusion

V10XX05

12.12.2022

9.12.2022

Spevigo

spesolimab

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/22/1688

Concentrate for solution for infusion

L04AC22

12.12.2022

12.12.2022

Dimethyl Fumarate Teva

dimethyl fumarate

Teva GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/22/1702

Gastro-resistant capsule, hard

L04AX07

3.1.2023

12.12.2022

Eladynos

abaloparatide

Radius Health (Ireland) Ltd.

13 Classon House, Dundrum Business Park, Dundrum, Dublin D14 W9Y3, Ireland

EU/1/22/1706

Solution for injection

H05AA04

13.12.2022

16.12.2022

Ebvallo

Tabelecleucel

Atara Biotherapeutics Ireland Limited

Arthur Cox Building, 10 Earlsfort Terrace, Dublin 2 D02 T380, Ireland

EU/1/22/1700

dispersion for injection

Pending

16.12.2022

16.12.2022

Plerixafor Accord

plerixafor

Accord Healthcare S.L.U.

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

EU/1/22/1701

Solution for injection

L03AX16

19.12.2022

20.12.2022

Zynlonta

loncastuximab tesirine

ADC Therapeutics (NL) B.V.

Laarderhoogtweg 25, Amsterdam, Noord-Holland, 1101 EB, Nederland

EU/1/22/1695

Powder for concentrate for solution for infusion

L01FX22

22.12.2022

—   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

2.12.2022

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

2.12.2022

2.12.2022

DuoPlavin

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

5.12.2022

2.12.2022

Kaftrio

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/20/1468

5.12.2022

2.12.2022

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/12/782

5.12.2022

2.12.2022

QINLOCK

Deciphera Pharmaceuticals (Netherlands) B.V.

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

EU/1/21/1569

8.12.2022

2.12.2022

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/050

7.12.2022

2.12.2022

Spikevax

MODERNA BIOTECH SPAIN, S.L.

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

EU/1/20/1507

7.12.2022

2.12.2022

Trizivir

ViiV Healthcare BV

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

EU/1/00/156

5.12.2022

2.12.2022

Trogarzo

Theratechnologies Europe Limited

4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland

EU/1/19/1359

14.12.2022

2.12.2022

Trydonis

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1274

5.12.2022

2.12.2022

Zyclara

Viatris Healthcare Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/12/783

6.12.2022

5.12.2022

Shingrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

6.12.2022

5.12.2022

Steglujan

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1266

6.12.2022

5.12.2022

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

6.12.2022

9.12.2022

Abevmy

Mylan IRE Healthcare Limited

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

EU/1/20/1515

14.12.2022

9.12.2022

Atriance

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57, 1000 Ljubljana, Slovenija

EU/1/07/403

12.12.2022

9.12.2022

Aybintio

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1454

13.12.2022

9.12.2022

Bortezomib Accord

Accord Healthcare S.L.U.

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

EU/1/15/1019

15.12.2022

9.12.2022

Deferiprone Lipomed

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/18/1310

12.12.2022

9.12.2022

Duaklir Genuair

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/14/964

12.12.2022

9.12.2022

Eklira Genuair

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/12/778

14.12.2022

9.12.2022

Erleada

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/18/1342

12.12.2022

9.12.2022

Eylea

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

13.12.2022

9.12.2022

Herzuma

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1257

14.12.2022

9.12.2022

Insulin aspart Sanofi

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1447

13.12.2022

9.12.2022

Insulin lispro Sanofi

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1203

13.12.2022

9.12.2022

Onbevzi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/20/1499

13.12.2022

9.12.2022

Oyavas

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/20/1510

12.12.2022

9.12.2022

Qarziba

EUSA Pharma (Netherlands) B.V.

Beechavenue 54, 1119PW Schiphol-Rijk, Nederland

EU/1/17/1191

14.12.2022

9.12.2022

Retsevmo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

12.12.2022

9.12.2022

Riarify

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1275

12.12.2022

9.12.2022

Spravato

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/19/1410

12.12.2022

9.12.2022

Suliqua

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/16/1157

13.12.2022

9.12.2022

Vaxelis

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden, Nederland

EU/1/15/1079

13.12.2022

9.12.2022

Vydura

Pfizer Europe MA EEIG

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

EU/1/22/1645

12.12.2022

9.12.2022

Xydalba

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/986

12.12.2022

9.12.2022

Zirabev

Pfizer Europe MA EEIG

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

EU/1/18/1344

12.12.2022

12.12.2022

Alymsys

Mabxience Research SL

C/ Manuel Pombo Angulo 28 — 3a y 4a Planta, 28050 Madrid, España

EU/1/20/1509

13.12.2022

12.12.2022

Cablivi

Ablynx N.V.

Technologiepark 21, 9052 Zwijnaarde, België

EU/1/18/1305

21.12.2022

12.12.2022

Dificlir

Tillotts Pharma GmbH

Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland

EU/1/11/733

13.12.2022

12.12.2022

DuoPlavin

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

14.12.2022

12.12.2022

Dupixent

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1229

13.12.2022

12.12.2022

Enhertu

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

13.12.2022

12.12.2022

Karvezide

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/085

13.12.2022

12.12.2022

Kisqali

Novartis Europharm Limited

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

EU/1/17/1221

13.12.2022

12.12.2022

Refixia

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/17/1193

13.12.2022

16.12.2022

Avastin

Roche Registration GmbH

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

EU/1/04/300

19.12.2022

16.12.2022

Bretaris Genuair

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/12/781

3.1.2023

16.12.2022

Brilique

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/655

19.12.2022

16.12.2022

Brimica Genuair

Covis Pharma Europe B.V.

Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland

EU/1/14/963

19.12.2022

16.12.2022

Caprelsa

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/11/749

19.12.2022

16.12.2022

Ceprotin

Baxter AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/01/190

19.12.2022

16.12.2022

Combivir

ViiV Healthcare BV

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

EU/1/98/058

19.12.2022

16.12.2022

Corbilta

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/13/859

20.12.2022

16.12.2022

DUAVIVE

Pfizer Europe MA EEIG

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

EU/1/14/960

20.12.2022

16.12.2022

DuoPlavin

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/10/619

19.12.2022

16.12.2022

Dupixent

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/17/1229

19.12.2022

16.12.2022

Eptifibatide Accord

Accord Healthcare S.L.U.

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

EU/1/15/1065

19.12.2022

16.12.2022

Granpidam

Accord Healthcare S.L.U.

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

EU/1/16/1137

19.12.2022

16.12.2022

Imatinib Accord

Accord Healthcare S.L.U.

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

EU/1/13/845

19.12.2022

16.12.2022

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

19.12.2022

16.12.2022

Inhixa

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland

EU/1/16/1132

22.12.2022

16.12.2022

Intuniv

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/15/1040

20.12.2022

16.12.2022

Iscover

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/070

19.12.2022

16.12.2022

Iscover

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/070

19.12.2022

16.12.2022

Iscover

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/070

19.12.2022

16.12.2022

Karvea

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/97/049

20.12.2022

16.12.2022

Levodopa/Carbidopa/Entacapone Orion

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/706

21.12.2022

16.12.2022

Lynparza

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

19.12.2022

16.12.2022

Moventig

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/14/962

21.12.2022

16.12.2022

Mvabea

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1445

20.12.2022

16.12.2022

Myalepta

Amryt Pharmaceuticals DAC

45 Mespil Road, Dublin 4, Ireland

EU/1/18/1276

21.12.2022

16.12.2022

Neulasta

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227

20.12.2022

16.12.2022

Ocaliva

ADVANZ PHARMA Limited

Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland

EU/1/16/1139

19.12.2022

16.12.2022

Ozawade

Bioprojet Pharma

9 rue Rameau, 75002 Paris, France

EU/1/21/1546

19.12.2022

16.12.2022

Plavix

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/069

19.12.2022

16.12.2022

Plavix

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/069

19.12.2022

16.12.2022

Plavix

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/98/069

19.12.2022

16.12.2022

Resolor

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/09/581

20.12.2022

16.12.2022

Rybelsus

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/20/1430

20.12.2022

16.12.2022

Sarclisa

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1435

19.12.2022

16.12.2022

Saxenda

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/15/992

19.12.2022

16.12.2022

Spikevax

MODERNA BIOTECH SPAIN, S.L.

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

EU/1/20/1507

19.12.2022

16.12.2022

Trajenta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/11/707

19.12.2022

16.12.2022

Tresiba

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/12/807

20.12.2022

16.12.2022

Truvelog Mix 30

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/22/1639

19.12.2022

16.12.2022

Twynsta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/10/648

3.1.2023

16.12.2022

Zoledronic acid Accord

Accord Healthcare S.L.U.

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

EU/1/13/834

19.12.2022

19.12.2022

Inrebic

Bristol-Myers Squibb Pharma EEIG

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

EU/1/20/1514

20.12.2022

20.12.2022

Ibandronic acid Accord

Accord Healthcare S.L.U.

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

EU/1/12/798

22.12.2022

20.12.2022

Mvasi

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

4.1.2023

20.12.2022

Rivaroxaban Accord

Accord Healthcare S.L.U.

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

EU/1/20/1488

22.12.2022

20.12.2022

Sarclisa

Sanofi Winthrop Industrie

82 avenue Raspail, 94250 Gentilly, France

EU/1/20/1435

21.12.2022

20.12.2022

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

21.12.2022

20.12.2022

Skytrofa

Ascendis Pharma Endocrinology Division A/S

Tuborg Boulevard 12, 2900 Hellerup, Danmark

EU/1/21/1607

21.12.2022

22.12.2022

Comirnaty

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

22.12.2022

22.12.2022

Paxlovid

Pfizer Europe MA EEIG

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

EU/1/22/1625

22.12.2022

—   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

5.12.2022

Trogarzo

Theratechnologies Europe Limited

4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland

EU/1/19/1359

5.1.2023

9.12.2022

NeuroBloc

Sloan Pharma S.a.r.l.

33 Rue de Puits Romain, 8070 Bertrange, Luxembourg

EU/1/00/166

12.12.2022

—   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

20.12.2022

NEOLEISH

Canine leishmaniasis vaccine (recombinant DNA plasmid)

CZ Veterinaria, S.A.

La Relva s/n — Torneiros, 36410 Porriño, España

EU/2/22/290

Nasal spray, solution

Pending

21.12.2022

—   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

2.12.2022

CYTOPOINT

Zoetis Belgium

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

EU/2/17/205

5.12.2022

2.12.2022

Fevaxyn Pentofel

Zoetis Belgium

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

EU/2/96/002

6.12.2022

2.12.2022

Solensia

Zoetis Belgium SA

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

EU/2/20/269

5.12.2022

2.12.2022

Tulissin

VIRBAC

1ère avenue 2065 m LID, 06516 Carros, France

EU/2/20/252

6.12.2022

2.12.2022

Zenalpha

Vetcare Oy

P.O. Box 99, 24101 Salo, Suomi

EU/2/21/279

7.12.2022

9.12.2022

Convenia

Zoetis Belgium

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

EU/2/06/059

14.12.2022

9.12.2022

Zeleris

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/210

14.12.2022

13.12.2022

Innovax-ND-ILT

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/20/256

14.12.2022

13.12.2022

Versican Plus DHPPi/L4R

Zoetis Belgium

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

EU/2/14/163

14.12.2022

15.12.2022

Exzolt

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/17/212

20.12.2022

15.12.2022

Librela

Zoetis Belgium SA

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

EU/2/20/261

21.12.2022

15.12.2022

NEXGARD SPECTRA

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/14/177

16.12.2022

15.12.2022

Porcilis PCV M Hyo

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/175

20.12.2022

15.12.2022

Simparica Trio

Zoetis Belgium

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

EU/2/19/243

20.12.2022

15.12.2022

Simparica Trio

Zoetis Belgium

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

EU/2/19/243

20.12.2022

15.12.2022

UBAC

Laboratorios Hipra, S.A.

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

EU/2/18/227

21.12.2022

15.12.2022

Versican Plus Pi/L4R

Zoetis Belgium

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

EU/2/14/173

16.12.2022

16.12.2022

Equip WNV

Zoetis Belgium

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

EU/2/08/086

20.12.2022

20.12.2022

Lydaxx

VETOQUINOL S.A.

Magny-Vernois, 70200 Lure, France

EU/2/20/253

21.12.2022

20.12.2022

Novem

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/042

22.12.2022

20.12.2022

Onsior

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/08/089

21.12.2022

20.12.2022

ProteqFlu

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/03/037

22.12.2022

20.12.2022

ProteqFlu-Te

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/03/038

22.12.2022

20.12.2022

Rabitec

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/17/219

21.12.2022

20.12.2022

RHINISENG

Laboratorios Hipra, S.A.

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

EU/2/10/109

22.12.2022

20.12.2022

Suprelorin

VIRBAC S.A.

1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France

EU/2/07/072

23.12.2022

20.12.2022

Tulaven

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/251

21.12.2022

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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