Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2022 to 30 September 2022 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 136, 30.4.2004, p. 1.) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L 4, 7.1.2019, p. 43.)) 2022/C 419/01
Date: 2022-10-31
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_2022419EN.01000101.xml










31.10.2022   


EN


Official Journal of the European Union


C 419/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2022 to 30 September 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 419/01)






—



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




15.9.2022


Amvuttra


vutrisiran







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/22/1681


Solution for injection


N07XX18


16.9.2022




15.9.2022


Celdoxome pegylated liposomal


doxorubicin hydrochloride







YES Pharmaceutical Development Services GmbH




Bahnstrasse 42-46, 61381 Friedrichsdorf, Deutschland






EU/1/22/1666


Concentrate for dispersion for infusion


L01DB01


22.9.2022




15.9.2022


ilLuzyce


lutetium (177Lu) chloride







Billev Pharma ApS




Slotsmarken 10, 2970 Hørsholm, Danmark






EU/1/22/1680


Radiopharmaceutical precursor, solution


V10X


16.9.2022




15.9.2022


Lupkynis


voclosporin







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/22/1678


Capsule, soft


L04AD03


19.9.2022




15.9.2022


Mounjaro


tirzepatide







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/22/1685


Solution for injection


Pending


19.9.2022




15.9.2022


NULIBRY


fosdenopterin







Comharsa Life Sciences Limited




10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland






EU/1/22/1684


Powder for solution for injection


A16AX


16.9.2022




15.9.2022


Opdualag


nivolumab/relatlimab







Bristol Myers Squibb Pharma EEIG




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






EU/1/22/1679


Concentrate for solution for infusion


L01XY03


16.9.2022




15.9.2022


Vabysmo


Faricimab







Roche Registration GmbH




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






EU/1/22/1683


Solution for injection


S01LA09


16.9.2022




19.9.2022


Tezspire


tezepelumab







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1677


Solution for injection


R03DX11


20.9.2022




19.9.2022


Thalidomide Lipomed


Thalidomide







Lipomed GmbH




Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland






EU/1/22/1676


Coated tablet


L04AX02


26.9.2022




21.9.2022


CRYSVITA


Burosumab







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/17/1262


Solution for injection


M05BX


29.9.2022














—



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




1.9.2022


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


1.9.2022




1.9.2022


Spikevax







MODERNA BIOTECH SPAIN, S.L.




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






EU/1/20/1507


1.9.2022




2.9.2022


Aprovel







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/97/046


5.9.2022




2.9.2022


CoAprovel







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/98/086


5.9.2022




2.9.2022


Copalia HCT







Novartis Europharm Limited




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






EU/1/09/575


5.9.2022




2.9.2022


Dafiro HCT







Novartis Europharm Limited




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






EU/1/09/574


5.9.2022




2.9.2022


Dupixent







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/17/1229


5.9.2022




2.9.2022


Imcivree







Rhythm Pharmaceuticals Netherlands B.V.




Radarweg 29, 1043 NX Amsterdam, Nederland






EU/1/21/1564


5.9.2022




2.9.2022


Januvia







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/07/383


7.9.2022




2.9.2022


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


5.9.2022




2.9.2022


Tecartus







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/20/1492


5.9.2022




2.9.2022


Zolgensma







Novartis Europharm Limited




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






EU/1/20/1443


12.9.2022




6.9.2022


Nuvaxovid







Novavax CZ, a.s.




Bohumil 138, 281 63 Jevany, Česká republika






EU/1/21/1618


7.9.2022




9.9.2022


Ceplene







Laboratoires Delbert




49 rue Rouelle, 75015 Paris, FRANCE






EU/1/08/477


12.9.2022




12.9.2022


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


12.9.2022




13.9.2022


Buvidal







Camurus AB




Ideon Science Park, 223 70 Lund, Sverige






EU/1/18/1336


14.9.2022




13.9.2022


Exforge HCT







Novartis Europharm Limited




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






EU/1/09/569


14.9.2022




13.9.2022


GAVRETO







Roche Registration GmbH




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






EU/1/21/1555


15.9.2022




13.9.2022


Izba







Novartis Europharm Limited




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






EU/1/13/905


14.9.2022




13.9.2022


JEMPERLI







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1538


14.9.2022




13.9.2022


Karvea







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/97/049


14.9.2022




13.9.2022


Karvezide







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/98/085


14.9.2022




13.9.2022


Ninlaro







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/16/1094


19.9.2022




13.9.2022


Oncaspar







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes Cedex, France






EU/1/15/1070


14.9.2022




13.9.2022


Temozolomide HEXAL







Hexal AG




Industriestraße 25, 83607 Holzkirchen, Deutschland






EU/1/10/616


19.9.2022




13.9.2022


Temozolomide Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/10/617


16.9.2022




13.9.2022


Tigecycline Accord







Accord Healthcare S.L.U.




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






EU/1/19/1394


14.9.2022




13.9.2022


Xeljanz







Pfizer Europe MA EEIG




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






EU/1/17/1178


14.9.2022




15.9.2022


Corlentor







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes CEDEX, France






EU/1/05/317


19.9.2022




15.9.2022


Fasenra







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/17/1252


16.9.2022




15.9.2022


Hemlibra







Roche Registration GmbH




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






EU/1/18/1271


16.9.2022




15.9.2022


Intrarosa







Endoceutics S.A.




Rue Belliard 40, 1040 Bruxelles, Belgique/ Belliardstraat 40, 1040 Brussel, België






EU/1/17/1255


18.9.2022




15.9.2022


Kinpeygo







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/22/1657


19.9.2022




15.9.2022


Nyxoid







Mundipharma Corporation (Ireland) Limited




Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland






EU/1/17/1238


16.9.2022




15.9.2022


Oxlumo







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/20/1496


16.9.2022




15.9.2022


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/06/380


16.9.2022




15.9.2022


Procoralan







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes CEDEX, France






EU/1/05/316


19.9.2022




15.9.2022


Stribild







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/13/830


19.9.2022




16.9.2022


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


19.9.2022




16.9.2022


EVUSHELD







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/22/1651


16.9.2022




16.9.2022


Spikevax







MODERNA BIOTECH SPAIN, S.L.




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






EU/1/20/1507


19.9.2022




16.9.2022


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


19.9.2022




19.9.2022


Miglustat Gen.Orph







Gen.Orph




185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France






EU/1/17/1232


21.9.2022




19.9.2022


Reblozyl







Bristol-Myers Squibb Pharma EEIG




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






EU/1/20/1452


23.9.2022




19.9.2022


SomaKit TOC







Advanced Accelerator Applications




20 rue Diesel, 01630 Saint-Genis-Pouilly, France






EU/1/16/1141


21.9.2022




19.9.2022


TAGRISSO







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/16/1086


20.9.2022




19.9.2022


Tarceva







Roche Registration GmbH




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






EU/1/05/311


21.9.2022




21.9.2022


Betmiga







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/12/809


26.9.2022




21.9.2022


Cervarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/07/419


26.9.2022




21.9.2022


Dafiro







Novartis Europharm Limited




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






EU/1/06/371


23.9.2022




21.9.2022


Daxas







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/10/636


23.9.2022




21.9.2022


Efficib







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/08/457


26.9.2022




21.9.2022


Evrysdi







Roche Registration GmbH




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






EU/1/21/1531


23.9.2022




21.9.2022


InductOs







Medtronic BioPharma B.V.




Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland






EU/1/02/226


23.9.2022




21.9.2022


Inlyta







Pfizer Europe MA EEIG




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






EU/1/12/777


26.9.2022




21.9.2022


Lyrica







Upjohn EESV




Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland






EU/1/04/279


27.9.2022




21.9.2022


Mvasi







Amgen Technology (Ireland) UC




Pottery Road, Dun Laoghaire, Co. Dublin, Ireland






EU/1/17/1246


26.9.2022




21.9.2022


Ocrevus







Roche Registration GmbH




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






EU/1/17/1231


23.9.2022




21.9.2022


Ozempic







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/17/1251


23.9.2022




21.9.2022


Rubraca







Clovis Oncology Ireland Limited




Regus Dublin Airport, Skybridge House - Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland






EU/1/17/1250


23.9.2022




21.9.2022


Tegsedi







Akcea Therapeutics Ireland Ltd




Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland






EU/1/18/1296


23.9.2022




21.9.2022


Tesavel







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/07/435


26.9.2022




21.9.2022


Travatan







Novartis Europharm Limited




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






EU/1/01/199


26.9.2022




21.9.2022


Tybost







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/13/872


28.9.2022




21.9.2022


Ultomiris







Alexion Europe SAS




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






EU/1/19/1371


23.9.2022




21.9.2022


Verkazia







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/17/1219


26.9.2022




21.9.2022


Zabdeno







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1444


27.9.2022




26.9.2022


Cometriq







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/13/890


27.9.2022




26.9.2022


Gencebok







Gennisium Pharma




Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles, France






EU/1/20/1465


28.9.2022




26.9.2022


Lamivudine / Zidovudine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/10/663


27.9.2022




26.9.2022


Lutathera







Advanced Accelerator Applications




20 rue Diesel, 01630 Saint-Genis-Pouilly, France






EU/1/17/1226


28.9.2022




26.9.2022


Pirfenidone axunio







axunio Pharma GmbH




Van-der-Smissen-Straße 1, 22767 Hamburg, Deutschland






EU/1/22/1655


27.9.2022




26.9.2022


Pregabalin Pfizer







Upjohn EESV




Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland






EU/1/14/916


27.10.2022




26.9.2022


Rybrevant







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/21/1594


27.9.2022




26.9.2022


TOOKAD







Steba Biotech S.A




7 Place du Théâtre, 2613 Luxembourg, Luxembourg






EU/1/17/1228


6.10.2022




27.9.2022


COVID-19 Vaccine (inactivated, adjuvanted) Valneva







Valneva Austria GmbH




Campus Vienna Biocenter 3, 1030 Wien, Österreich






EU/1/21/1624


29.9.2022




27.9.2022


Jorveza







Dr Falk Pharma GmbH




Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland






EU/1/17/1254


28.9.2022




29.9.2022


ABILIFY MAINTENA







Otsuka Pharmaceutical Netherlands B.V.




Herikerbergweg 292, 1101 CT, Amsterdam, Nederland






EU/1/13/882


3.10.2022




29.9.2022


Byooviz







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/21/1572


4.10.2022




29.9.2022


CABOMETYX







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/16/1136


30.9.2022




29.9.2022


Copalia







Novartis Europharm Limited




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






EU/1/06/372


30.9.2022




29.9.2022


Dupixent







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/17/1229


30.9.2022




29.9.2022


Efient







SUBSTIPHARM




24 rue Erlanger, 75016 Paris, France






EU/1/08/503


30.9.2022




29.9.2022


Entresto







Novartis Europharm Limited




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






EU/1/15/1058


3.10.2022




29.9.2022


Exforge







Novartis Europharm Limited




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






EU/1/06/370


30.9.2022




29.9.2022


IVEMEND







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/07/437


3.10.2022




29.9.2022


Janumet







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/08/455


29.9.2022




29.9.2022


Lydisilka







Estetra SRL




Rue Saint Georges 5-7, 4000 Liège, Belgique






EU/1/21/1548


3.10.2022




29.9.2022


Paxlovid







Pfizer Europe MA EEIG




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






EU/1/22/1625


30.9.2022




29.9.2022


PHELINUN







ADIENNE S.r.l.S.U.




Via Galileo Galilei 19, 20867 Caponago (MB), Italia






EU/1/20/1487


30.9.2022




29.9.2022


Ristaben







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/10/621


30.9.2022




29.9.2022


Ristfor







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/10/620


29.9.2022




29.9.2022


Simbrinza







Novartis Europharm Limited




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






EU/1/14/933


3.10.2022




29.9.2022


TAKHZYRO







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/18/1340


3.10.2022




29.9.2022


Vaniqa







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/01/173


3.10.2022




29.9.2022


Velmetia







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/08/456


30.9.2022




30.9.2022


Evrenzo







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/21/1574


3.10.2022




30.9.2022


Lamivudine Teva Pharma B.V.







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/596


3.10.2022














—



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




15.9.2022


Temozolomide HEXAL







Hexal AG




Industriestraße 25, 83607 Holzkirchen, Deutschland






EU/1/10/616


19.9.2022




15.9.2022


Temozolomide Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/10/617


21.9.2022














—



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




13.9.2022


Lotilaner Elanco


lotilaner







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/22/288


Chewable tablet


QP53BE04


14.9.2022














—



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




2.9.2022


Aivlosin







ECO Animal Health Europe Limited




6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland






EU/2/04/044


14.9.2022




2.9.2022


Zenalpha


Vetcare Oy
P.O. Box 99, 24101 Salo, Suomi


EU/2/21/279


5.9.2022




13.9.2022


Equisolon


Le Vet B.V.
Wilgenweg 7, 3421 TV Oudewater, Nederland


EU/2/14/161


30.9.2022




13.9.2022


Poulvac E. coli







Zoetis Belgium S.A.




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






EU/2/12/140


16.9.2022




13.9.2022


Suiseng Diff/A







Laboratorios Hipra, S.A.




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






EU/2/21/278


15.9.2022




15.9.2022


Bonqat







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/21/273


16.9.2022




15.9.2022


Nobivac LeuFel







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/17/217


28.9.2022




15.9.2022


Sileo







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/15/181


16.9.2022




19.9.2022


Suprelorin







VIRBAC S.A.




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






EU/2/07/072


22.9.2022




26.9.2022


Clomicalm







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/98/007


28.9.2022




26.9.2022


Leucofeligen FeLV/RCP







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/09/097


28.9.2022




26.9.2022


Meloxoral







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/10/111


27.9.2022




26.9.2022


Vaxxitek HVT + IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/02/032


28.9.2022




29.9.2022


Arti-Cell Forte







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/18/228


5.10.2022




29.9.2022


Bovilis Blue-8







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/218


30.9.2022




29.9.2022


Leucogen







Virbac




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






EU/2/09/096


4.10.2022




29.9.2022


PREVEXXION RN







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/254


4.10.2022




29.9.2022


PREVEXXION RN+HVT+IBD







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/255


4.10.2022




29.9.2022


Suvaxyn Circo + MH RTU







Zoetis Belgium S.A.




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






EU/2/15/190


4.10.2022














—



Withdrawal 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)









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




29.9.2022


Activyl Tick Plus







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/11/137


30.9.2022




29.9.2022


Nobilis OR inac







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/02/036


30.9.2022








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.