Official Journal of the European Union

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.