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)
Date: 2021-07-30
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_2021307EN.01000101.xml










30.7.2021   


EN


Official Journal of the European Union


C 307/1






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.