Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2022 to 31 July 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: 2022-08-31
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_2022331EN.01000101.xml










31.8.2022   


EN


Official Journal of the European Union


C 331/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2022 to 31 July 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 331/01)
—   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




1.7.2022


LIBTAYO


cemiplimab







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27 Ireland






EU/1/19/1376


Concentrate for solution for infusion


L01XC33


5.7.2022




15.7.2022


Cevenfacta


eptacog beta (activated)







Laboratoire français du Fractionnement et des Biotechnologies




Tour W, 102 Terrasse Boieldieu, 19ème Étage, 92800 Puteaux France






EU/1/22/1664


Powder and solvent for solution for injection


B02BD08


22.7.2022




15.7.2022


Ertapenem SUN


ertapenem







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87, 2132JH Hoofddorp, Nederland






EU/1/22/1656


Powder for concentrate for solution for infusion


J01DH03


22.7.2022




15.7.2022


Ganirelix Gedeon Richter


ganirelix







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/22/1658


Solution for injection


H01CC01


19.7.2022




15.7.2022


Kinpeygo


budesonide







Calliditas Therapeutics AB




Kungsbron 1, 11122 Stockholm, Sverige






EU/1/22/1657


Modified-release capsule, hard


A07EA06


18.7.2022




15.7.2022


Sugammadex Fresenius Kabi


sugammadex







Fresenius Kabi Deutschland GmbH




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






EU/1/22/1663


Solution for injection


V03AB35


18.7.2022




18.7.2022


NEXPOVIO


selinexor







Karyopharm Europe GmbH




Franziska-Bilek-Weg 9, 80339 München, Deutschland






EU/1/21/1537


Film-coated tablet


L01XX66


19.7.2022




18.7.2022


Upstaza


eladocagene exuparvovec







PTC Therapeutics International Limited




70 Sir John Rogerson's Quay, Dublin 2, Ireland






EU/1/22/1653


Solution for infusion


Pending


22.7.2022




18.7.2022


Zokinvy


lonafarnib







EigerBio Europe Limited




1 Castlewood Avenue, Rathmines, Dublin 6, D06 H685, Ireland






EU/1/22/1660


Capsule, hard


A16AX20


19.7.2022




22.7.2022


Sitagliptin/Metformin hydrochloride Accord


sitagliptin/metformin hydrochloride







Accord Healthcare S.L.U.




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






EU/1/22/1661


Film-coated tablet


A10BD07


28.7.2022




—   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




1.7.2022


Armisarte







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/15/1063


6.7.2022




1.7.2022


Entecavir Accord







Accord Healthcare S.L.U.




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






EU/1/17/1211


4.7.2022




1.7.2022


Hetlioz







Vanda Pharmaceuticals Netherlands B.V.




Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland






EU/1/15/1008


8.8.2022




1.7.2022


Irbesartan / Hydrochlorothiazide Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/583


4.7.2022




1.7.2022


Kinzalkomb







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/02/214


5.7.2022




1.7.2022


Levodopa/Carbidopa/Entacapone Orion







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/11/706


11.7.2022




1.7.2022


Neparvis







Novartis Europharm Limited




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






EU/1/16/1103


7.7.2022




1.7.2022


Nuvaxovid







Novavax CZ, a.s.




Bohumil 138, 281 63 Jevany, Česká republika






EU/1/21/1618


1.7.2022




1.7.2022


Orladeyo







Biocryst Ireland Limited




Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland






EU/1/21/1544


5.7.2022




1.7.2022


Paxlovid







Pfizer Europe MA EEIG




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






EU/1/22/1625


1.7.2022




1.7.2022


Strensiq







Alexion Europe SAS




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






EU/1/15/1015


4.7.2022




1.7.2022


Viramune







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/97/055


19.7.2022




1.7.2022


Zirabev







Pfizer Europe MA EEIG




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






EU/1/18/1344


4.7.2022




4.7.2022


Prialt







Esteve Pharmaceuticals GmbH




Hohenzollerndamm 150-151, 14199 Berlin, Deutschland






EU/1/04/302


7.7.2022




8.7.2022


Amsparity







Pfizer Europe MA EEIG




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






EU/1/19/1415


12.7.2022




8.7.2022


AUBAGIO







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/13/838


11.7.2022




8.7.2022


Azacitidine Betapharm







betapharm Arzneimittel GmbH




Kobelweg 95, 86156 Augsburg, Deutschland






EU/1/19/1416


12.7.2022




8.7.2022


Azacitidine Mylan







Mylan Ireland Limited




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






EU/1/20/1426


12.7.2022




8.7.2022


Calquence







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/20/1479


11.7.2022




8.7.2022


Dexdor







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/11/718


11.7.2022




8.7.2022


EDURANT







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/11/736


12.7.2022




8.7.2022


Efmody







Diurnal Europe B.V.




Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland






EU/1/21/1549


13.7.2022




8.7.2022


Eurartesim







Alfasigma S.p.A.




Via Ragazzi del '99, n.5, 40133 Bologna, Italia






EU/1/11/716


12.7.2022




8.7.2022


Farydak







Secura Bio Limited




32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland






EU/1/15/1023


14.7.2022




8.7.2022


Fingolimod Accord







Accord Healthcare S.L.U.




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






EU/1/20/1450


11.7.2022




8.7.2022


Fortacin







Recordati Ireland Ltd




Raheens East, Ringaskiddy Co. Cork, Ireland






EU/1/13/881


12.7.2022




8.7.2022


Giapreza







PAION Deutschland GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/19/1384


13.7.2022




8.7.2022


Grasustek







Juta Pharma GmbH




Gutenbergstr. 13, 24941, Flensburg, Deutschland






EU/1/19/1375


12.7.2022




8.7.2022


Herceptin







Roche Registration GmbH




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






EU/1/00/145


11.7.2022




8.7.2022


Iclusig







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/13/839


15.7.2022




8.7.2022


INCRELEX







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/07/402


12.7.2022




8.7.2022


Kadcyla







Roche Registration GmbH




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






EU/1/13/885


11.7.2022




8.7.2022


Keppra







UCB Pharma S.A.




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






EU/1/00/146


12.7.2022




8.7.2022


Lenalidomide Mylan







Mylan Ireland Limited




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






EU/1/20/1490


11.7.2022




8.7.2022


Lutathera







Advanced Accelerator Applications




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






EU/1/17/1226


11.7.2022




8.7.2022


Mabthera







Roche Registration GmbH




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






EU/1/98/067


11.7.2022




8.7.2022


MicardisPlus







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/02/213


13.7.2022




8.7.2022


Minjuvi







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1570


11.7.2022




8.7.2022


Mvasi







Amgen Technology (Ireland) UC




Pottery Road, Dun Laoghaire, Co. Dublin, Ireland






EU/1/17/1246


12.7.2022




8.7.2022


Orgovyx







Accord Healthcare S.L.U.




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






EU/1/22/1642


11.7.2022




8.7.2022


Palforzia







Aimmune Therapeutics Ireland Limited




Block B, The Crescent Building, Northwood Crescent Northwood, Dublin 9, D09 C6X8 Ireland






EU/1/20/1495


12.7.2022




8.7.2022


Pemetrexed Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1037


12.7.2022




8.7.2022


Quinsair







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/14/973


13.7.2022




8.7.2022


Striascan







CIS bio international




RN 306 — Saclay, B.P. 32, F-91192 Gif-sur-Yvette Cedex, France






EU/1/19/1372


11.7.2022




8.7.2022


Tepadina







ADIENNE S.r.l.S.U.




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






EU/1/10/622


12.7.2022




8.7.2022


Thiotepa Riemser







Esteve Pharmaceuticals GmbH




Hohenzollerndamm 150-151, 14199 Berlin, Deutschland






EU/1/21/1536


11.7.2022




8.7.2022


Tracleer







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/02/220


11.7.2022




8.7.2022


Vimpat







UCB Pharma S.A.




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






EU/1/08/470


11.7.2022




8.7.2022


Votrient







Novartis Europharm Limited




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






EU/1/10/628


11.7.2022




8.7.2022


Xeloda







CHEPLAPHARM Arzneimittel GmbH




Ziegelhof 24, 17489 Greifswald, Deutschland






EU/1/00/163


11.7.2022




8.7.2022


Xenleta







Nabriva Therapeutics Ireland DAC




Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland






EU/1/20/1457


13.7.2022




8.7.2022


Yondelis







Pharma Mar S.A.




Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España






EU/1/07/417


12.7.2022




11.7.2022


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


13.7.2022




15.7.2022


Alecensa







Roche Registration GmbH




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






EU/1/16/1169


19.7.2022




15.7.2022


AYVAKYT







Blueprint Medicines (Netherlands) B.V.




Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland






EU/1/20/1473


18.7.2022




15.7.2022


Edistride







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/15/1052


19.7.2022




15.7.2022


Elebrato Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1237


19.7.2022




15.7.2022


Emgality







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/18/1330


19.7.2022




15.7.2022


Forxiga







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/12/795


19.7.2022




15.7.2022


Fotivda







EUSA Pharma (Netherlands) B.V.




Beechavenue 54, 1119PW Schiphol-Rijk, Nederland






EU/1/17/1215


10.8.2022




15.7.2022


Galvus







Novartis Europharm Limited




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






EU/1/07/414


18.7.2022




15.7.2022


Idefirix







Hansa Biopharma AB




P.O. Box 785, 220 07 Lund, Sverige






EU/1/20/1471


19.7.2022




15.7.2022


Jalra







Novartis Europharm Limited




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






EU/1/08/485


18.7.2022




15.7.2022


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


19.7.2022




15.7.2022


PecFent







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/10/644


20.7.2022




15.7.2022


Posaconazole AHCL







Accord Healthcare S.L.U.




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






EU/1/19/1380


3.8.2022




15.7.2022


Raxone







Santhera Pharmaceuticals (Deutschland) GmbH




Marie-Curie Straße 8, 79539 Lörrach, Deutschland






EU/1/15/1020


2.8.2022




15.7.2022


Remsima







Celltrion Healthcare Hungary Kft.




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






EU/1/13/853


18.7.2022




15.7.2022


Trelegy Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1236


19.7.2022




15.7.2022


Tremfya







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/17/1234


19.7.2022




15.7.2022


Xiliarx







Novartis Europharm Limited




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






EU/1/08/486


18.7.2022




18.7.2022


Accofil







Accord Healthcare S.L.U.




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






EU/1/14/946


8.8.2022




18.7.2022


Bortezomib Fresenius Kabi







Fresenius Kabi Deutschland GmbH




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






EU/1/19/1397


20.7.2022




18.7.2022


Cyramza







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/14/957


22.7.2022




18.7.2022


Darunavir Krka d.d.







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/17/1248


20.7.2022




18.7.2022


Irbesartan Zentiva







Zentiva k.s.




U kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/06/376


19.7.2022




18.7.2022


Lenalidomide Krka







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/20/1519


22.7.2022




18.7.2022


Mayzent







Novartis Europharm Limited




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






EU/1/19/1414


19.7.2022




18.7.2022


Suboxone







Indivior Europe Limited




27 Windsor Place, Dublin 2, D02 DK44, Ireland






EU/1/06/359


22.7.2022




18.7.2022


Zejula







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1235


20.7.2022




19.7.2022


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


19.7.2022




22.7.2022


Fluad Tetra







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/20/1433


28.7.2022




22.7.2022


Imvanex







Bavarian Nordic A/S




Philip Heymans Allé 3, DK-2900 Hellerup, Danmark






EU/1/13/855


25.7.2022




22.7.2022


Kirsty







Mylan IRE Healthcare Limited




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






EU/1/20/1506


26.7.2022




22.7.2022


Lonquex







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/13/856


2.8.2022




22.7.2022


Miglustat Dipharma







Dipharma B.V.




Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland






EU/1/18/1346


26.7.2022




22.7.2022


Onureg







Bristol-Myers Squibb Pharma EEIG




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






EU/1/21/1556


27.7.2022




22.7.2022


Rinvoq







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


25.7.2022




22.7.2022


Ryeqo







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/21/1565


27.7.2022




22.7.2022


Xevudy







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1562


22.7.2022




22.7.2022


Zavesca







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/02/238


26.7.2022




25.7.2022


Braftovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1314


26.7.2022




25.7.2022


CRYSVITA







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/17/1262


28.7.2022




25.7.2022


Cyramza







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/14/957


27.7.2022




25.7.2022


Zerbaxa







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1032


26.7.2022




27.7.2022


BroPair Spiromax







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/21/1534


2.8.2022




27.7.2022


Flucelvax Tetra







Seqirus Netherlands B.V.




Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland






EU/1/18/1326


29.7.2022




27.7.2022


Fluenz Tetra







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/13/887


28.7.2022




27.7.2022


Phesgo







Roche Registration GmbH




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






EU/1/20/1497


29.7.2022




27.7.2022


Rinvoq







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


28.7.2022




27.7.2022


Seffalair Spiromax







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/21/1533


2.8.2022




27.7.2022


Zubsolv







Accord Healthcare S.L.U.




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






EU/1/17/1233


8.8.2022




28.7.2022


COVID-19 Vaccine (inactivated, adjuvanted) Valneva







Valneva Austria GmbH




Campus Vienna Biocenter 3, 1030 Wien, Österreich






EU/1/21/1624


29.7.2022




—   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




1.7.2022


Thymanax







Servier (Ireland) Industries Limited




Gorey Road, Arklow, Co. Wicklow, Ireland






EU/1/08/498


5.7.2022




—   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




27.7.2022


Cortaderm


Hydrocortisone aceponate







Alfasan Nederland B.V.




Kuipersweg 9, 3449 JA Woerden, Nederland






EU/2/22/287


Cutaneous spray, solution


QD07AC16


29.7.2022




27.7.2022


Evanovo


Coccidiosis vaccine live for chickens







Laboratorios Hipra, S.A.




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






EU/2/22/284


Suspension and solvent for suspension for injection


Pending


28.7.2022




—   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




4.7.2022


BTVPUR







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/10/113


5.7.2022




4.7.2022


Tulinovet







V.M.D.n.v.




Hoge Mauw 900, 2370 Arendonk, Belgïe






EU/2/20/257


5.7.2022




11.7.2022


Coliprotec F4/F18







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/16/202


12.7.2022




11.7.2022


HorStem







EquiCord S.L




103-D Loeches, Polígono. Industrial Ventorro del Cano, Alcorcón, 28925 Madrid, España.






EU/2/18/226


12.7.2022




11.7.2022


Loxicom







Norbrook Laboratories (Ireland) Limited




Rossmore Industrial Estate, Monaghan, Ireland






EU/2/08/090


14.7.2022




11.7.2022


Prevomax







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/17/211


13.7.2022




11.7.2022


VEPURED







Laboratorios Hipra, S.A.




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






EU/2/17/214


14.7.2022




15.7.2022


Bravecto







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/13/158


19.7.2022




15.7.2022


Cerenia







Zoetis Belgium S.A.




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






EU/2/06/062


19.7.2022




15.7.2022


GUMBOHATCH







Laboratorios Hipra, S.A.




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






EU/2/19/245


19.7.2022




15.7.2022


Nobivac L4







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/12/143


19.7.2022




15.7.2022


Suprelorin







VIRBAC S.A.




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






EU/2/07/072


19.7.2022




15.7.2022


Suvaxyn PRRS MLV







Zoetis Belgium S.A.




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






EU/2/17/215


22.7.2022




22.7.2022


Comfortis







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/10/115


27.7.2022




22.7.2022


FRONTPRO







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/19/240


25.7.2022




22.7.2022


GALLIPRANT







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/17/221


27.7.2022




22.7.2022


Onsior







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/08/089


27.7.2022




22.7.2022


Vectra Felis







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/14/165


26.7.2022




22.7.2022


VEPURED







Laboratorios Hipra, S.A.




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






EU/2/17/214


27.7.2022




27.7.2022


Circovac







CEVA-Phylaxia Co. Ltd




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/07/075


29.7.2022




27.7.2022


Loxicom







Norbrook Laboratories (Ireland) Limited




Rossmore Industrial Estate, Monaghan, Ireland






EU/2/08/090


29.7.2022




27.7.2022


Nobilis IB 4-91







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/98/006


29.7.2022




—   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




22.7.2022


Bovilis BTV8







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/10/106


9.8.2022




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.