Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2021 to 30 June 2021

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2021/C 307/01)

— 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 17.6.2021 Adtralza tralokinumab Leo Pharma A/S Industriparken 55, 2750 Ballerup, Danmark EU/1/21/1554 Solution for injection in a pre-filled syringe D11AH07 18.6.2021 17.6.2021 Celsunax ioflupane (123I) Pinax Pharma GmbH Lausitz, Mühlenweg 5, 04924 Bad Liebenwerda, Deutschland EU/1/21/1560 Solution for injection V09AB03 21.6.2021 17.6.2021 Evkeeza evinacumab Regeneron Ireland Designated Activity Company (DAC) One Warrington Place, Dublin 2, D02 HH27 Ireland EU/1/21/1551 Concentrate for solution for infusion C10AX 18.6.2021 17.6.2021 Koselugo selumetinib AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1552 Capsule, hard L01EE04 19.6.2021 17.6.2021 Onureg azacitidine Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/21/1556 Film-coated tablet L01BC07 21.6.2021 21.6.2021 Jayempi azathioprine Nova Laboratories Ireland Limited 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland EU/1/21/1557 Oral suspension L04AX01 23.6.2021 24.6.2021 Abiraterone Krka abiraterone acetate KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/21/1553 Film-coated tablet L02BX03 28.6.2021 24.6.2021 Enspryng satralizumab Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/21/1559 Solution for injection L04AC19 29.6.2021

— 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 1.6.2021 Cinqaero Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/16/1125 3.6.2021 1.6.2021 Clopidogrel Taw Pharma Taw Pharma (Ireland) Limited 104 Lower Baggot Street, Dublin 2, Ireland EU/1/09/568 2.6.2021 1.6.2021 NULOJIX Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/11/694 2.6.2021 1.6.2021 OPDIVO Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 2.6.2021 1.6.2021 Rebetol Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/99/107 3.6.2021 1.6.2021 YERVOY Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/11/698 2.6.2021 1.6.2021 Zejula GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/17/1235 24.6.2021 4.6.2021 Aripiprazole Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1009 7.6.2021 4.6.2021 Clopidogrel ratiopharm Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/14/975 7.6.2021 4.6.2021 Hulio Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1319 9.6.2021 4.6.2021 Irbesartan HCT Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/06/377 7.6.2021 4.6.2021 Isturisa Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/19/1407 9.6.2021 4.6.2021 Lamivudine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/566 7.6.2021 4.6.2021 Levetiracetam SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/11/741 8.6.2021 4.6.2021 Puregon N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/96/008 8.6.2021 4.6.2021 Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/15/1003 7.6.2021 14.6.2021 Elonva N.V. Organon P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland EU/1/09/609 16.6.2021 14.6.2021 Levetiracetam Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/11/713 16.6.2021 14.6.2021 Levetiracetam ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/11/702 16.6.2021 17.6.2021 Atripla Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/07/430 19.6.2021 17.6.2021 AUBAGIO Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/13/838 21.6.2021 17.6.2021 Bonviva Atnahs Pharma Netherlands B.V. Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark EU/1/03/265 18.6.2021 17.6.2021 Cinacalcet Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/1054 23.6.2021 17.6.2021 Copalia HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/575 18.6.2021 17.6.2021 Dafiro HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/574 18.6.2021 17.6.2021 Delstrigo Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1333 18.6.2021 17.6.2021 Dexmedetomidine Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/19/1418 21.6.2021 17.6.2021 Dovprela Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1437 18.6.2021 17.6.2021 Duloxetine Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/972 21.6.2021 17.6.2021 Emtriva Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/03/261 19.6.2021 17.6.2021 Enbrel Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/99/126 18.6.2021 17.6.2021 Eviplera Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/11/737 28.6.2021 17.6.2021 Exforge HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/569 21.6.2021 17.6.2021 Fabrazyme Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/01/188 18.6.2021 17.6.2021 Inovelon Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/06/378 20.6.2021 17.6.2021 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/930 21.6.2021 17.6.2021 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 18.6.2021 17.6.2021 Kisplyx Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/16/1128 20.6.2021 17.6.2021 Levetiracetam Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/701 18.6.2021 17.6.2021 Matever Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/11/711 18.6.2021 17.6.2021 Mysimba Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/14/988 21.6.2021 17.6.2021 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 25.6.2021 17.6.2021 Nustendi Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/20/1424 2.7.2021 17.6.2021 Pioglitazone Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/758 2.7.2021 17.6.2021 Resolor Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland EU/1/09/581 20.6.2021 17.6.2021 Ritemvia Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1207 28.6.2021 17.6.2021 Sarclisa Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/20/1435 18.6.2021 17.6.2021 Sialanar Proveca Pharma Limited Marine House, Clanwilliam Place, Dublin 2, Ireland EU/1/16/1135 18.6.2021 17.6.2021 TAVLESSE Instituto Grifols, S.A. Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espaňa EU/1/19/1405 21.6.2021 17.6.2021 Translarna PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland EU/1/13/902 18.6.2021 17.6.2021 Trulicity Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/956 21.6.2021 17.6.2021 Xgeva Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/11/703 18.6.2021 17.6.2021 Xtandi Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/13/846 20.6.2021 17.6.2021 Yentreve Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/280 18.6.2021 17.6.2021 Zerbaxa Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1032 29.6.2021 21.6.2021 APTIVUS Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/05/315 22.6.2021 21.6.2021 Arsenic Trioxide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/19/1398 22.6.2021 21.6.2021 BLENREP GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/20/1474 22.6.2021 21.6.2021 Bortezomib SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/16/1102 23.6.2021 21.6.2021 Competact CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24, 17489 Greifswald, Deutschland EU/1/06/354 8.7.2021 21.6.2021 Cymbalta Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/296 22.6.2021 21.6.2021 Darzalex Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/16/1101 23.6.2021 21.6.2021 Eucreas Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/425 24.6.2021 21.6.2021 EVOTAZ Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1025 22.6.2021 21.6.2021 Eylea Bayer AG D-51368 Leverkusen, Deutschland EU/1/12/797 9.7.2021 21.6.2021 Fetcroja Shionogi B.V. Kingsfordweg 151, 1043 GR Amsterdam, Nederland EU/1/20/1434 22.6.2021 21.6.2021 Firmagon Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark EU/1/08/504 23.6.2021 21.6.2021 Galvus Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/414 24.6.2021 21.6.2021 Humalog Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/96/007 22.6.2021 21.6.2021 Jalra Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/485 24.6.2021 21.6.2021 Lemtrada Sanofi Belgium Leonardo Da Vincilaan 19, B-1831 Diegem, België EU/1/13/869 23.6.2021 21.6.2021 Levetiracetam Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/11/712 22.6.2021 21.6.2021 Levetiracetam Actavis Group Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/11/738 22.6.2021 21.6.2021 LIBTAYO Regeneron Ireland Designated Activity Company (DAC) One Warrington Place, Dublin 2, D02 HH27 Ireland EU/1/19/1376 22.6.2021 21.6.2021 LIBTAYO Regeneron Ireland Designated Activity Company (DAC) One Warrington Place, Dublin 2, D02 HH27 Ireland EU/1/19/1376 22.6.2021 21.6.2021 Maviret AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/17/1213 22.6.2021 21.6.2021 Nepexto Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1436 24.6.2021 21.6.2021 Nordimet Nordic Group B.V. Siriusdreef 41, 2132 WT Hoofddorp, Nederland EU/1/16/1124 23.6.2021 21.6.2021 Ogivri Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1341 23.6.2021 21.6.2021 Otezla Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/14/981 22.6.2021 21.6.2021 Pioglitazone Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/757 22.6.2021 21.6.2021 Riarify Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/18/1275 22.6.2021 21.6.2021 Ribavirin Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/509 24.6.2021 21.6.2021 Ribavirin Teva Pharma BV Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/527 24.6.2021 21.6.2021 Rozlytrek Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/20/1460 23.6.2021 21.6.2021 Somavert Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/02/240 23.6.2021 21.6.2021 Targretin Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/01/178 22.6.2021 21.6.2021 Venclyxto AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/16/1138 22.6.2021 21.6.2021 Xarelto Bayer AG D-51368 Leverkusen, Deutschland EU/1/08/472 2.7.2021 21.6.2021 Xiliarx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/486 24.6.2021 24.6.2021 Abasaglar Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/944 28.6.2021 24.6.2021 BLINCYTO Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1047 25.6.2021 24.6.2021 Glidipion Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/12/756 25.6.2021 24.6.2021 Hexacima Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/13/828 8.7.2021 24.6.2021 Ibandronic acid Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/12/798 28.6.2021 24.6.2021 Imnovid Bristol Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland EU/1/13/850 26.6.2021 24.6.2021 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 1.7.2021 24.6.2021 Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/10/637 28.6.2021 24.6.2021 Olanzapine Apotex Apotex Europe B.V. Archimedesweg 2, 2333 CN, Leiden, Nederland EU/1/10/635 13.7.2021 24.6.2021 OPDIVO Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 29.6.2021 24.6.2021 Pioglitazone Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/12/755 25.6.2021 24.6.2021 Protopic Leo Pharma A/S Industriparken 55, 2750 Ballerup, Danmark EU/1/02/201 2.7.2021 24.6.2021 Roteas Berlin-Chemie AG Glienicker Weg 125, 12489 Berlin, Deutschland EU/1/16/1152 29.6.2021 24.6.2021 Segluromet Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1265 29.6.2021 24.6.2021 Tandemact CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24, 17489 Greifswald, Deutschland EU/1/06/366 8.7.2021 24.6.2021 Veklury Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1459 28.6.2021 24.6.2021 YERVOY Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/11/698 25.6.2021 25.6.2021 Triumeq ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/14/940 2.7.2021 28.6.2021 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 1.7.2021 28.6.2021 Hexyon Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/13/829 29.6.2021 28.6.2021 Isentress Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/436 29.6.2021 28.6.2021 Spherox CO.DON AG Warthestraße 21, 14513 Teltow, Deutschland EU/1/17/1181 1.7.2021 28.6.2021 Vidaza Bristol Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland EU/1/08/488 29.6.2021

— 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 14.6.2021 Ulipristal Acetate Gedeon Richter Gedeon Richter Plc. Gyömrői út 19-21, 1103 Budapest, Magyarország EU/1/18/1309 13.7.2021 21.6.2021 Lextemy Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1516 23.6.2021 21.6.2021 Pioglitazone Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/758 22.6.2021 21.6.2021 Ritemvia Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1207 2.7.2021 22.6.2021 Ribavirin Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/509 24.6.2021 22.6.2021 Ribavirin Teva Pharma BV Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/527 24.6.2021

— Modification of a marketing authorisation (Article 38 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 1.6.2021 Reconcile FORTE Healthcare Ltd Cougar Lane, Naul, Co. Dublin, Ireland EU/2/08/080 2.6.2021 4.6.2021 Comfortis Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/10/115 14.6.2021 14.6.2021 Bovilis Blue-8 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/17/218 18.6.2021 22.6.2021 Porcilis ColiClos Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/12/141 23.6.2021 22.6.2021 RESPIPORC FLUpan H1N1 Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/17/209 23.6.2021 22.6.2021 Stronghold Plus Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/16/204 13.7.2021

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, 30.4.04, p. 1.