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)
Date: 2023-01-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2023037EN.01000101.xml










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.