Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2022 to 30 June 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: 2022-07-29
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_2022289EN.01000101.xml










29.7.2022   


EN


Official Journal of the European Union


C 289/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2022 to 30 June 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 289/01)
—   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




3.6.2022


Lunsumio


mosunetuzumab







Roche Registration GmbH




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






EU/1/22/1649


Concentrate for solution for infusion


L01XC


7.6.2022




14.6.2022


Yselty


linzagolix choline







ObsEva Ireland Ltd.




Penthouse Floor, 5 Lapps Quay, Cork, T12 RW7D, Ireland






EU/1/21/1606


Film-coated tablet


Pending


17.6.2022




20.6.2022


Pirfenidone AET


pirfenidone







Alfred E. Tiefenbacher (GmbH & Co. KG)




Van der Smissen Strasse 1, 22767 Hamburg, Deutschland






EU/1/22/1655


Film-coated tablet


L04AX05


27.6.2022




20.6.2022


Tabrecta


capmatinib







Novartis Europharm Limited




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






EU/1/22/1650


Film-coated tablet


L01EX17


21.6.2022




21.6.2022


Filsuvez


birch bark extract







Amryt Pharmaceuticals DAC




45 Mespil Road, Dublin 4, Ireland






EU/1/22/1652


Gel


D03AX13


23.6.2022




24.6.2022


Nexviadyme


avalglucosidase alfa







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1579


Powder for concentrate for solution for infusion


Pending


27.6.2022




24.6.2022


Xenpozyme


olipudase alfa







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/22/1659


Powder for concentrate for solution for infusion


A16AB25


27.6.2022




—   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




2.6.2022


Abraxane







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/428


8.6.2022




2.6.2022


Anoro Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/898


5.6.2022




2.6.2022


Comtan







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/98/081


3.6.2022




2.6.2022


Cufence







Univar Solutions B.V.




Schouwburgplein 30, Rotterdam, 3012 CL, Nederland






EU/1/19/1365


7.6.2022




2.6.2022


Exviera







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/14/983


3.6.2022




2.6.2022


HALAVEN







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/11/678


3.6.2022




2.6.2022


Imcivree







Rhythm Pharmaceuticals Netherlands B.V.




Radarweg 29, 1043 NX Amsterdam, Nederland






EU/1/21/1564


7.6.2022




2.6.2022


Instanyl







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/09/531


14.6.2022




2.6.2022


Ketoconazole HRA







HRA Pharma Rare Diseases




200 avenue de Paris, 92320 Chatillon, France






EU/1/14/965


14.6.2022




2.6.2022


Kigabeq







ORPHELIA Pharma SAS




85 boulevard Saint-Michel, 75005 Paris, France






EU/1/18/1302


10.6.2022




2.6.2022


Posaconazole Accord







Accord Healthcare S.L.U.




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






EU/1/19/1379


7.6.2022




2.6.2022


Slenyto







RAD Neurim Pharmaceuticals EEC SARL




4 rue de Marivaux, 75002 Paris, France






EU/1/18/1318


7.6.2022




2.6.2022


Sugammadex Mylan







Mylan Ireland Limited




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






EU/1/21/1583


21.6.2022




2.6.2022


Trulicity







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/14/956


7.6.2022




2.6.2022


TUKYSA







Seagen B.V.




Evert van de Beekstraat 1-104, 1118CL Schiphol, Nederland






EU/1/20/1526


7.6.2022




2.6.2022


Viekirax







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/14/982


3.6.2022




2.6.2022


Vyxeos liposomal







Jazz Pharmaceuticals Ireland Ltd




5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland






EU/1/18/1308


7.6.2022




2.6.2022


Zepatier







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/16/1119


14.6.2022




7.6.2022


Benlysta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/11/700


13.6.2022




7.6.2022


Constella







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/12/801


13.6.2022




7.6.2022


CONTROLOC Control







Takeda GmbH




Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland






EU/1/09/515


9.6.2022




7.6.2022


Ifirmacombi







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/11/673


9.6.2022




7.6.2022


Ilaris







Novartis Europharm Limited




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






EU/1/09/564


8.6.2022




7.6.2022


Irbesartan HCT Zentiva







Zentiva k.s.




U kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/06/377


9.6.2022




7.6.2022


Mozobil







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/09/537


8.6.2022




7.6.2022


Ondexxya







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1345


20.6.2022




7.6.2022


PANTOZOL Control







Takeda GmbH




Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland






EU/1/09/517


9.6.2022




7.6.2022


Perjeta







Roche Registration GmbH




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






EU/1/13/813


8.6.2022




7.6.2022


Rebetol







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/99/107


14.6.2022




7.6.2022


Rivastigmine Actavis







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/11/693


8.6.2022




7.6.2022


SOMAC Control







Takeda GmbH




Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland






EU/1/09/516


9.6.2022




7.6.2022


Stayveer







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/832


8.6.2022




7.6.2022


Tecentriq







Roche Registration GmbH




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






EU/1/17/1220


8.6.2022




7.6.2022


Truvada







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/04/305


8.6.2022




7.6.2022


VELCADE







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/04/274


8.6.2022




7.6.2022


Xeplion







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/11/672


8.6.2022




13.6.2022


Afinitor







Novartis Europharm Limited




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






EU/1/09/538


15.6.2022




13.6.2022


Aimovig







Novartis Europharm Limited




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






EU/1/18/1293


14.6.2022




13.6.2022


Descovy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1099


14.6.2022




13.6.2022


Enurev Breezhaler







Novartis Europharm Limited




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






EU/1/12/789


14.6.2022




13.6.2022


Feraccru







Norgine B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/15/1075


21.6.2022




13.6.2022


Fintepla







Zogenix ROI Limited




Trinity House, Charleston Road, Ranelagh, Dublin 6, D06 C8X4, Ireland






EU/1/20/1491


14.6.2022




13.6.2022


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


15.6.2022




13.6.2022


Leqvio







Novartis Europharm Limited




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






EU/1/20/1494


15.6.2022




13.6.2022


Nyvepria







Pfizer Europe MA EEIG




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






EU/1/20/1486


14.6.2022




13.6.2022


Ozurdex







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/10/638


14.6.2022




13.6.2022


Pelgraz







Accord Healthcare S.L.U.




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






EU/1/18/1313


15.6.2022




13.6.2022


Pregabalin Accord







Accord Healthcare S.L.U.




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






EU/1/15/1027


15.6.2022




13.6.2022


Xydalba







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/14/986


14.6.2022




14.6.2022


Lacosamide UCB







UCB Pharma S.A.




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






EU/1/19/1383


20.6.2022




14.6.2022


Odefsey







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1112


15.6.2022




14.6.2022


Xermelo







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/17/1224


29.6.2022




20.6.2022


Cosentyx







Novartis Europharm Limited




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






EU/1/14/980


21.6.2022




20.6.2022


Ilumetri







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/18/1323


21.6.2022




20.6.2022


OBIZUR







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/15/1035


21.6.2022




20.6.2022


Olumiant







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/16/1170


21.6.2022




20.6.2022


Translarna







PTC Therapeutics International Limited




5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland






EU/1/13/902


21.6.2022




21.6.2022


Cresemba







Basilea Pharmaceutica Deutschland GmbH




Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland






EU/1/15/1036


22.6.2022




21.6.2022


Cuprymina







A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.




Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia






EU/1/12/784


22.6.2022




21.6.2022


Elonva







N.V. Organon




P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland






EU/1/09/609


23.6.2022




21.6.2022


Entecavir Mylan







Mylan Pharmaceuticals Limited




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






EU/1/17/1227


22.6.2022




21.6.2022


Hepcludex







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1446


27.6.2022




21.6.2022


Hycamtin







Novartis Europharm Limited




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






EU/1/96/027


22.6.2022




21.6.2022


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


29.6.2022




21.6.2022


Lemtrada







Sanofi Belgium




Leonardo Da Vincilaan 19, B-1831 Diegem, België






EU/1/13/869


22.6.2022




21.6.2022


Mektovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1315


22.6.2022




21.6.2022


Mysimba







Orexigen Therapeutics Ireland Limited




2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland






EU/1/14/988


23.6.2022




21.6.2022


NexoBrid







MediWound Germany GmbH




Hans-Sachs-Strasse 100, 65428 Rüsselsheim, Deutschland






EU/1/12/803


27.6.2022




21.6.2022


Pemetrexed Fresenius Kabi







Fresenius Kabi Deutschland GmbH




Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland






EU/1/16/1115


27.6.2022




21.6.2022


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


22.6.2022




21.6.2022


TOOKAD







Steba Biotech S.A




7 Place du Théâtre, 2613 Luxembourg, Luxembourg






EU/1/17/1228


23.6.2022




21.6.2022


Vocabria







ViiV Healthcare BV




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






EU/1/20/1481


22.6.2022




21.6.2022


Votubia







Novartis Europharm Limited




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






EU/1/11/710


23.6.2022




21.6.2022


XALKORI







Pfizer Europe MA EEIG




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






EU/1/12/793


22.6.2022




21.6.2022


Xaluprine







Nova Laboratories Ireland Limited




3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland






EU/1/11/727


27.6.2022




21.6.2022


Yescarta







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/18/1299


23.6.2022




22.6.2022


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


27.6.2022




24.6.2022


Abecma







Bristol-Myers Squibb Pharma EEIG




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






EU/1/21/1539


27.6.2022




24.6.2022


Azopt







Novartis Europharm Limited




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






EU/1/00/129


27.6.2022




24.6.2022


Bretaris Genuair







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/12/781


27.6.2022




24.6.2022


Brimica Genuair







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/14/963


27.6.2022




24.6.2022


Deferasirox Accord







Accord Healthcare S.L.U.




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






EU/1/19/1412


27.6.2022




24.6.2022


Defitelio







Gentium S.r.I.




Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia






EU/1/13/878


28.6.2022




24.6.2022


Defitelio







Gentium S.r.I.




Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia






EU/1/13/878


28.6.2022




24.6.2022


Dificlir







Tillotts Pharma GmbH




Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland






EU/1/11/733


30.6.2022




24.6.2022


Duaklir Genuair







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/14/964


27.6.2022




24.6.2022


Eklira Genuair







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/12/778


27.6.2022




24.6.2022


Norvir







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/96/016


27.6.2022




24.6.2022


Ocaliva







Intercept Pharma International Limited




Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland






EU/1/16/1139


28.6.2022




24.6.2022


Onbevzi







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/20/1499


29.6.2022




24.6.2022


Oncaspar







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/15/1070


27.6.2022




24.6.2022


Spravato







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/19/1410


27.6.2022




24.6.2022


Temodal







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/98/096


28.6.2022




24.6.2022


TRIXEO AEROSPHERE







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/20/1498


27.6.2022




24.6.2022


Xeljanz







Pfizer Europe MA EEIG




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






EU/1/17/1178


28.6.2022




24.6.2022


Zometa







Phoenix Labs Unlimited Company




Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland






EU/1/01/176


30.6.2022




29.6.2022


Alymsys







Mabxience Research SL




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






EU/1/20/1509


4.7.2022




29.6.2022


Apixaban Accord







Accord Healthcare S.L.U.




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






EU/1/20/1458


30.6.2022




29.6.2022


BLENREP







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/20/1474


30.6.2022




29.6.2022


Cerezyme







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/97/053


30.6.2022




29.6.2022


Dacogen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/12/792


30.6.2022




29.6.2022


Epidyolex







GW Pharma (International) B.V.




Databankweg 26, 3821AL Amersfoort, Nederland






EU/1/19/1389


30.6.2022




29.6.2022


Isentress







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/07/436


30.6.2022




29.6.2022


LIBTAYO







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27 Ireland






EU/1/19/1376


30.6.2022




29.6.2022


Optruma







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/98/074


1.7.2022




29.6.2022


PritorPlus







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/02/215


1.7.2022




29.6.2022


Respreeza







CSL Behring GmbH




Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland






EU/1/15/1006


1.7.2022




29.6.2022


Vizamyl







GE Healthcare AS




Nycoveien 1, 0485, Oslo, Norge






EU/1/14/941


30.6.2022




29.6.2022


Vizimpro







Pfizer Europe MA EEIG




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






EU/1/19/1354


30.6.2022




29.6.2022


Xerava







PAION Deutschland GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/18/1312


30.6.2022




30.6.2022


Enspryng







Roche Registration GmbH




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






EU/1/21/1559


4.7.2022




—   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




7.6.2022


Episalvan







Amryt GMBH




Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland






EU/1/15/1069


8.6.2022




24.6.2022


Senstend







Plethora Pharma Solutions Ltd.




32 Merrion Street Upper, Dublin 2, Ireland






EU/1/19/1387


28.6.2022




—   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




3.6.2022


Reconcile







FORTE Healthcare Ltd




Cougar Lane, Naul, Co. Dublin, Ireland






EU/2/08/080


8.6.2022




3.6.2022


Syvazul BTV







LABORATORIOS SYVA, S.A.U.




Av. Párroco Pablo Diez 49-57, 24010 León, España






EU/2/18/231


30.6.2022




13.6.2022


Increxxa







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/20/258


14.6.2022




13.6.2022


Purevax RCP







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/052


20.6.2022




14.6.2022


Purevax RC







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/051


20.6.2022




14.6.2022


Purevax RCPCh FeLV







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/047


20.6.2022




14.6.2022


Suprelorin







VIRBAC S.A.




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






EU/2/07/072


16.6.2022




20.6.2022


Prevomax







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/17/211


29.6.2022




20.6.2022


REXXOLIDE







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/20/263


27.6.2022




24.6.2022


Apoquel







Zoetis Belgium S.A.




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






EU/2/13/154


28.6.2022




24.6.2022


Emdocam







Emdoka bvba




J. Lijsenstraat 16, 2321 Hoogstraten, België






EU/2/11/128


30.6.2022




24.6.2022


Enteroporc Coli AC







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/20/262


27.6.2022




24.6.2022


Innovax-ND-IBD







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/213


28.6.2022




24.6.2022


Lydaxx







VETOQUINOL S.A.




Magny-Vernois, 70200 Lure, France






EU/2/20/253


30.6.2022




24.6.2022


Neptra







Bayer Animal Health GmbH




D-51368 Leverkusen, Deutschland






EU/2/19/246


30.6.2022




24.6.2022


Purevax RC







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/051


27.6.2022




24.6.2022


Purevax RCP







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/052


28.6.2022




24.6.2022


Purevax RCPCh







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/050


28.6.2022




24.6.2022


Purevax RCPCh







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/050


27.6.2022




24.6.2022


Purevax RCPCh FeLV







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/047


27.6.2022




24.6.2022


Purevax RCP FeLV







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/048


27.6.2022




24.6.2022


Purevax RCP FeLV







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/04/048


27.6.2022




24.6.2022


Sileo







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/15/181


28.6.2022




24.6.2022


Vectormune ND







CEVA-Phylaxia Co. Ltd




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/15/188


3.7.2022




24.6.2022


Zenalpha







Vetcare Oy




P.O. Box 99, 24101 Salo, Suomi






EU/2/21/279


27.6.2022




28.6.2022


CLYNAV







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/16/197


29.6.2022




29.6.2022


Porcilis PCV







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/08/091


1.7.2022




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.