Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2023 to 31 March 2023 (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: 2023-04-28
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_2023153EN.01000101.xml










28.4.2023   


EN


Official Journal of the European Union


C 153/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2023 to 31 March 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 153/01)
—   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




20.3.2023


Pombiliti


cipaglucosidase alfa







Amicus Therapeutics Europe Limited




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






EU/1/22/1714


Powder for concentrate for solution for infusion


A16AB23


24.3.2023




24.3.2023


Dapagliflozin Viatris


dapagliflozin







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/23/1721


Film-coated tablet


A10BK01


27.3.2023




24.3.2023


SOTYKTU


deucravacitinib







Bristol Myers Squibb Pharma EEIG




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






EU/1/23/1718


Film-coated tablet


L04AA56


27.3.2023




24.3.2023


Tolvaptan Accord


tolvaptan







Accord Healthcare S.L.U.




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






EU/1/23/1719


Tablet


C03XA01


27.3.2023




31.3.2023


Sitagliptin/Metformin hydrochloride SUN


sitagliptin / metformin hydrochloride







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87, 2132JH Hoofddorp, Nederland






EU/1/23/1720


Film-coated tablet


A10BD07


3.4.2023




—   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




3.3.2023


Vumerity







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/21/1585


7.3.2023




3.3.2023


Zolgensma







Novartis Europharm Limited




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






EU/1/20/1443


6.3.2023




6.3.2023


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


13.3.2023




6.3.2023


Firmagon







Ferring Pharmaceuticals A/S




Amager Strandvej 405, 2770 Kastrup, Danmark






EU/1/08/504


8.3.2023




6.3.2023


Natpar







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/15/1078


7.3.2023




6.3.2023


Nevirapine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/598


7.3.2023




6.3.2023


Omidria







Rayner Surgical (Ireland) Limited




First Floor, Penrose 1, Penrose Dock, Cork, Ireland






EU/1/15/1018


8.3.2023




6.3.2023


Temomedac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/09/605


10.3.2023




6.3.2023


Temozolomide Accord







Accord Healthcare S.L.U.




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






EU/1/10/615


7.3.2023




6.3.2023


Trecondi







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/18/1351


8.3.2023




6.3.2023


Trulicity







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/14/956


7.3.2023




6.3.2023


Xtandi







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/13/846


7.3.2023




9.3.2023


Aybintio







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/20/1454


13.3.2023




9.3.2023


BLINCYTO







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1047


10.3.2023




9.3.2023


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


16.3.2023




9.3.2023


Onbevzi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/20/1499


13.3.2023




9.3.2023


Pandemic influenza vaccine H5N1 AstraZeneca







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1089


10.3.2023




9.3.2023


Rozlytrek







Roche Registration GmbH




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






EU/1/20/1460


10.3.2023




9.3.2023


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


10.3.2023




9.3.2023


Zynlonta







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/22/1695


13.3.2023




10.3.2023


Cibinqo







Pfizer Europe MA EEIG




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






EU/1/21/1593


13.3.2023




10.3.2023


Jyseleca







Galapagos NV




Generaal De Wittelaan L11 A3, 2800 Mechelen Antwerp, België






EU/1/20/1480


13.3.2023




10.3.2023


Olumiant







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/16/1170


13.3.2023




10.3.2023


Rinvoq







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


13.3.2023




10.3.2023


Xeljanz







Pfizer Europe MA EEIG




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






EU/1/17/1178


13.3.2023




15.3.2023


ADVATE







Takeda Manufacturing Austria AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/03/271


16.3.2023




15.3.2023


Azacitidine Accord







Accord Healthcare S.L.U.




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






EU/1/19/1413


16.3.2023




15.3.2023


Dovato







ViiV Healthcare BV




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






EU/1/19/1370


16.3.2023




15.3.2023


Dupixent







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/17/1229


17.3.2023




15.3.2023


Galafold







Amicus Therapeutics Europe Limited




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






EU/1/15/1082


24.3.2023




15.3.2023


Hexacima







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/13/828


23.3.2023




15.3.2023


Hexyon







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/13/829


16.3.2023




15.3.2023


Jentadueto







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/12/780


16.3.2023




15.3.2023


Plenadren







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/11/715


16.3.2023




15.3.2023


Ponvory







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/21/1550


16.3.2023




15.3.2023


Tenkasi







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/15/989


16.3.2023




17.3.2023


Aptivus







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/05/315


20.3.2023




17.3.2023


Deferasirox Mylan







Mylan Pharmaceuticals Limited




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






EU/1/19/1386


20.3.2023




17.3.2023


Entyvio







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/14/923


20.3.2023




17.3.2023


Ngenla







Pfizer Europe MA EEIG




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






EU/1/21/1617


20.3.2023




17.3.2023


VEYVONDI







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/18/1298


21.3.2023




20.3.2023


Dasatinib Accord







Accord Healthcare S.L.U.




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






EU/1/21/1540


23.3.2023




20.3.2023


Enbrel







Pfizer Europe MA EEIG




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






EU/1/99/126


22.3.2023




20.3.2023


NUCEIVA







Evolus Pharma B.V.




Apollolaan 151, 1077 AR Amsterdam, Nederland






EU/1/19/1364


22.3.2023




20.3.2023


Pandemic influenza vaccine H5N1 BAXTER







Resilience Biomanufacturing Ireland Limited




2 Shelbourne Buildings, Crampton Avenue, Dublin 4, D04 W3V6, Ireland






EU/1/09/571


23.3.2023




20.3.2023


Prasugrel Mylan







Mylan Pharmaceuticals Limited




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






EU/1/18/1273


22.3.2023




20.3.2023


Pregabalin Sandoz GmbH







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1012


27.3.2023




20.3.2023


Trazimera







Pfizer Europe MA EEIG




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






EU/1/18/1295


22.3.2023




20.3.2023


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


3.4.2023




23.3.2023


Dasatinib Accordpharma







Accord Healthcare S.L.U.




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






EU/1/21/1541


27.3.2023




24.3.2023


Abiraterone Mylan







Mylan Ireland Limited




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






EU/1/21/1571


27.3.2023




24.3.2023


Apealea







Inceptua AB




Gustavslundsv. 143, 16751 Bromma, Sverige






EU/1/18/1292


28.3.2023




24.3.2023


CARVYKTI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/22/1648


28.3.2023




24.3.2023


COVID-19 Vaccine (inactivated, adjuvanted) Valneva







Valneva Austria GmbH




Campus Vienna Biocenter 3, 1030 Wien, Österreich






EU/1/21/1624


29.3.2023




24.3.2023


Deltyba







Otsuka Novel Products GmbH




Erika-Mann-Straße 21, 80636 München, Deutschland






EU/1/13/875


30.3.2023




24.3.2023


Dzuveo







Laboratoire Aguettant




1 Rue Alexander Fleming, 69007 Lyon, France






EU/1/18/1284


29.3.2023




24.3.2023


Emadine







Immedica Pharma AB




SE-113 63, Stockholm, Sverige






EU/1/98/095


12.4.2023




24.3.2023


Esbriet







Roche Registration GmbH




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






EU/1/11/667


27.3.2023




24.3.2023


Esperoct







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/19/1374


27.3.2023




24.3.2023


Ivabradine Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1144


27.3.2023




24.3.2023


Kineret







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/02/203


27.3.2023




24.3.2023


LIBTAYO







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27 Ireland






EU/1/19/1376


27.3.2023




24.3.2023


Palynziq







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland






EU/1/19/1362


27.3.2023




24.3.2023


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


27.3.2023




24.3.2023


Roclanda







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/20/1502


28.3.2023




24.3.2023


Sibnayal







ADVICENNE




262, rue du Faubourg Saint Honoré 75008 Paris, France






EU/1/20/1517


27.3.2023




24.3.2023


TachoSil







Corza Medical GmbH




Speditionstraße 21, 40221 Düsseldorf, Deutschland






EU/1/04/277


28.3.2023




24.3.2023


Tegsedi







Akcea Therapeutics Ireland Ltd




St. James House, 72 Adelaide Road, Dublin 2, D02 Y017, Ireland






EU/1/18/1296


4.4.2023




24.3.2023


Zeposia







Bristol-Myers Squibb Pharma EEIG




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






EU/1/20/1442


27.3.2023




24.3.2023


ZINPLAVA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/16/1156


28.3.2023




31.3.2023


Bavencio







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/17/1214


4.4.2023




31.3.2023


Byfavo







PAION Deutschland GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/20/1505


3.4.2023




31.3.2023


Edarbi







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/11/734


13.4.2023




31.3.2023


Eliquis







Bristol-Myers Squibb/Pfizer EEIG




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






EU/1/11/691


3.4.2023




31.3.2023


Febuxostat Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/18/1347


5.4.2023




31.3.2023


Gardasil 9







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1007


4.4.2023




31.3.2023


Hefiya







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1287


3.4.2023




31.3.2023


Hyrimoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1286


3.4.2023




31.3.2023


Imraldi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/17/1216


4.4.2023




31.3.2023


MenQuadfi







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/20/1483


3.4.2023




31.3.2023


Myalepta







Amryt Pharmaceuticals DAC




45 Mespil Road, Dublin 4, Ireland






EU/1/18/1276


4.4.2023




31.3.2023


Ozempic







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/17/1251


11.4.2023




31.3.2023


Pioglitazone Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/12/757


4.4.2023




31.3.2023


Ryeqo







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/21/1565


3.4.2023




31.3.2023


Sialanar







Proveca Pharma Limited




2 Dublin Landings, North Wall Quay, Dublin 1, Ireland






EU/1/16/1135


5.4.2023




31.3.2023


TOBI Podhaler







Viatris Healthcare Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/10/652


3.4.2023




31.3.2023


Verkazia







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/17/1219


4.4.2023




31.3.2023


Wegovy







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/21/1608


11.4.2023




—   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




6.3.2023


Nevirapine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/598


7.3.2023




9.3.2023


Lamivudine / Zidovudine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/10/663


14.3.2023




25.3.2023


Dasatinib Accord







Accord Healthcare S.L.U.




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






EU/1/21/1540


27.3.2023




25.3.2023


Dasatinib Accordpharma







Accord Healthcare S.L.U.




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






EU/1/21/1541


27.3.2023




31.3.2023


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


4.4.2023




31.3.2023


Pioglitazone Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/12/757


4.4.2023




—   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




31.3.2023


Bovilis Nasalgen-C


Bovine coronavirus vaccine, live attenuated







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/23/294


Lyophilisate and solvent for suspension for nasal administration


QI02AD10


3.4.2023




31.3.2023


Eurican L4


Canine leptospirosis vaccine (inactivated)







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/23/293


Suspension for injection


QI07AB01


4.4.2023




—   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




1.3.2023


Nobivac Myxo-RHD PLUS







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/19/244


5.3.2023




1.3.2023


Simparica Trio







Zoetis Belgium




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






EU/2/19/243


2.3.2023




9.3.2023


Clevor







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/17/222


22.3.2023




9.3.2023


EVANT







Laboratorios Hipra, S.A.




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






EU/2/18/233


13.3.2023




9.3.2023


Nobivac L4







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/12/143


15.3.2023




9.3.2023


Purevax RC







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/051


13.3.2023




9.3.2023


Recocam







Bimeda Animal Health Limited




2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland






EU/2/11/133


10.3.2023




17.3.2023


Halocur







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/99/013


22.3.2023




17.3.2023


Versican Plus DHPPi/L4







Zoetis Belgium SA




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






EU/2/14/164


20.3.2023




17.3.2023


Versican Plus DHPPi/L4R







Zoetis Belgium




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






EU/2/14/163


20.3.2023




17.3.2023


Versican Plus L4







Zoetis Belgium




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






EU/2/14/171


20.3.2023




24.3.2023


Equip WNV







Zoetis Belgium




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






EU/2/08/086


3.4.2023




24.3.2023


Naxcel







Zoetis Belgium SA




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






EU/2/05/053


28.3.2023




24.3.2023


Porcilis PCV M Hyo







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/14/175


29.3.2023




24.3.2023


Versican Plus Pi/L4R







Zoetis Belgium




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






EU/2/14/173


27.3.2023




31.3.2023


Aservo EquiHaler







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/19/249


4.4.2023




31.3.2023


Bravecto Plus







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/18/224


3.4.2023




31.3.2023


BTVPUR







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/10/113


5.4.2023




31.3.2023


Coxevac







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/10/110


4.4.2023




31.3.2023


GALLIPRANT







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/17/221


3.4.2023




31.3.2023


GUMBOHATCH







Laboratorios Hipra, S.A.




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






EU/2/19/245


6.4.2023




31.3.2023


Innovax-ND-IBD







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/213


3.4.2023




31.3.2023


Librela







Zoetis Belgium




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






EU/2/20/261


11.4.2023




31.3.2023


Lotilaner Elanco







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/22/288


3.4.2023




31.3.2023


Purevax RCP FeLV







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/048


4.4.2023




31.3.2023


Suprelorin







VIRBAC S.A.




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






EU/2/07/072


5.4.2023




31.3.2023


Suvaxyn PRRS MLV







Zoetis Belgium




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






EU/2/17/215


5.4.2023




31.3.2023


Suvaxyn PRRS MLV







Zoetis Belgium




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






EU/2/17/215


5.4.2023




31.3.2023


Zeleris







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/17/210


4.4.2023




31.3.2023


Zolvix







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/09/101


3.4.2023




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.