Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2021 to 30 November 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2021-12-29
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_2021527EN.01000101.xml










29.12.2021   


EN


Official Journal of the European Union


C 527/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2021 to 30 November 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 527/01)
—   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




12.11.2021


Libmyris


adalimumab







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/21/1590


Solution for injection


L04AB04


16.11.2021




12.11.2021


Rivaroxaban Mylan


rivaroxaban







Mylan Ireland Limited




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






EU/1/21/1588


Tablet


B01AF01


3.12.2021




15.11.2021


Hukyndra


adalimumab







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/21/1589


Solution for injection


L04AB04


16.11.2021




15.11.2021


Sugammadex Mylan


sugammadex







Mylan Ireland Limited




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






EU/1/21/1583


Solution for injection


V03AB35


3.12.2021




15.11.2021


Vumerity


diroximel fumarate







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/21/1585


Gastro-resistant capsule, hard


L04AX09


16.11.2021




18.11.2021


GAVRETO


pralsetinib







Roche Registration GmbH




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






EU/1/21/1555


Capsule, hard


L01EX23


22.11.2021




18.11.2021


QINLOCK


ripretinib







Deciphera Pharmaceuticals (Netherlands) B.V.




Atrium Building Floor 4th, Strawinskylaan 3051, Amsterdam, Noord-Holland, 1077 ZX, Nederland






EU/1/21/1569


Tablet


L01EX19


24.11.2021




22.11.2021


Artesunate Amivas


artesunate







Amivas Ireland Limited




Durands Court 7, Parnell Street, Waterford, Ireland






EU/1/21/1582


Powder and solvent for solution for injection


P01BE03


24.11.2021




22.11.2021


Brukinsa


zanubrutinib







BeiGene Ireland Limited




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






EU/1/21/1576


Capsule, hard


L01EL03


23.11.2021




22.11.2021


Trodelvy


sacituzumab govitecan







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/21/1592


Powder for concentrate for solution for infusion


L01FX17


23.11.2021




—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected










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




15.11.2021


Raylumis







Pfizer Europe MA EEIG




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






—


17.11.2021




—   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




3.11.2021


Besponsa







Pfizer Europe MA EEIG




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






EU/1/17/1200


4.11.2021




3.11.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


3.11.2021




3.11.2021


Extavia







Novartis Europharm Limited




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






EU/1/08/454


8.11.2021




3.11.2021


Fulvestrant Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/17/1253


4.11.2021




3.11.2021


Lamzede







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/17/1258


5.11.2021




3.11.2021


Pregabalin Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/15/997


4.11.2021




3.11.2021


Pregabalin Mylan Pharma







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/15/998


5.11.2021




3.11.2021


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle Monte Esquinza 30, 28010 Madrid, España






EU/1/20/1507


4.11.2021




9.11.2021


Clopidogrel Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/09/568


30.11.2021




9.11.2021


Enyglid







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/580


1.12.2021




9.11.2021


Luxturna







Novartis Europharm Limited




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






EU/1/18/1331


10.11.2021




9.11.2021


Sutent







Pfizer Europe MA EEIG




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






EU/1/06/347


10.11.2021




9.11.2021


Talmanco







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/16/1153


1.12.2021




9.11.2021


Tegsedi







Akcea Therapeutics Ireland Ltd




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






EU/1/18/1296


30.11.2021




9.11.2021


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


10.11.2021




11.11.2021


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle Monte Esquinza 30, 28010 Madrid, España






EU/1/20/1507


12.11.2021




12.11.2021


Akynzeo







Helsinn Birex Pharmaceuticals Ltd




Damastown, Mulhuddart, Dublin 15, Ireland






EU/1/15/1001


19.11.2021




12.11.2021


Atriance







Novartis Europharm Limited




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






EU/1/07/403


15.11.2021




12.11.2021


Atripla







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/07/430


15.11.2021




12.11.2021


Daptomycin Hospira







Pfizer Europe MA EEIG




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






EU/1/17/1175


16.11.2021




12.11.2021


Dzuveo







Laboratoire Aguettant




1 Rue Alexander Fleming, 69007 Lyon, France






EU/1/18/1284


16.11.2021




12.11.2021


Edistride







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/15/1052


15.11.2021




12.11.2021


Enhertu







Daiichi Sankyo Europe GmbH




Zielstattstraße 48, 81379 München, Deutschland






EU/1/20/1508


2.12.2021




12.11.2021


Evoltra







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/06/334


16.11.2021




12.11.2021


Iasibon







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/10/659


16.11.2021




12.11.2021


Jyseleca







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1480


15.11.2021




12.11.2021


Lacosamide Accord







Accord Healthcare S.L.U.




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






EU/1/17/1230


15.11.2021




12.11.2021


Lyrica







Upjohn EESV




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






EU/1/04/279


3.12.2021




12.11.2021


Ninlaro







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbæk Strand, Danmark






EU/1/16/1094


1.12.2021




12.11.2021


Nucala







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/15/1043


15.11.2021




12.11.2021


Olanzapine Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/08/475


15.11.2021




12.11.2021


Olumiant







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/16/1170


16.11.2021




12.11.2021


Sevelamer carbonate Winthrop







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/14/952


7.12.2021




12.11.2021


SomaKit TOC







Advanced Accelerator Applications




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






EU/1/16/1141


16.11.2021




12.11.2021


Steglujan







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1266


15.11.2021




12.11.2021


Stelara







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/08/494


15.11.2021




12.11.2021


Suliqua







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/16/1157


15.11.2021




12.11.2021


Tadalafil Lilly







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/17/1177


15.11.2021




12.11.2021


Tivicay







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/13/892


17.11.2021




12.11.2021


Viagra







Upjohn EESV




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






EU/1/98/077


3.12.2021




12.11.2021


Xermelo







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/17/1224


8.12.2021




15.11.2021


Aldurazyme







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/03/253


7.12.2021




15.11.2021


Brilique







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/10/655


17.11.2021




15.11.2021


Clopidogrel Taw Pharma







Taw Pharma (Ireland) Limited




104 Lower Baggot Street, Dublin 2, Ireland






EU/1/09/559


25.11.2021




15.11.2021


Dovato







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/19/1370


17.11.2021




15.11.2021


Emtricitabine/Tenofovir disoproxil Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/16/1133


16.11.2021




15.11.2021


Fasturtec







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/00/170


16.11.2021




15.11.2021


Forxiga







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/12/795


17.11.2021




15.11.2021


Gardasil







MSD VACCINS




162 avenue Jean Jaurès, 69007 Lyon, France






EU/1/06/357


17.11.2021




15.11.2021


Hizentra







CSL Behring GmbH




Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland






EU/1/11/687


18.11.2021




15.11.2021


Hulio







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/18/1319


17.11.2021




15.11.2021


Invokana







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/884


16.11.2021




15.11.2021


Jorveza







Dr Falk Pharma GmbH




Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland






EU/1/17/1254


16.11.2021




15.11.2021


Kevzara







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/17/1196


16.11.2021




15.11.2021


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


20.11.2021




15.11.2021


Myalepta







Amryt Pharmaceuticals DAC




45 Mespil Road, Dublin 4, Ireland






EU/1/18/1276


18.11.2021




15.11.2021


Praluent







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/15/1031


16.11.2021




15.11.2021


Remicade







Janssen Biologics B.V.




Einsteinweg 101, 2333 CB Leiden, Nederland






EU/1/99/116


19.11.2021




15.11.2021


Rilutek







Sanofi Mature IP




54 rue La Boétie, 75008, Paris, France






EU/1/96/010


18.11.2021




15.11.2021


Sirturo







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/901


16.11.2021




15.11.2021


Skyrizi







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1361


16.11.2021




15.11.2021


Thyrogen







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/99/122


17.11.2021




15.11.2021


Triumeq







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/14/940


17.11.2021




15.11.2021


Truxima







Celltrion Healthcare Hungary Kft.




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






EU/1/16/1167


16.11.2021




15.11.2021


Xeljanz







Pfizer Europe MA EEIG




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






EU/1/17/1178


17.11.2021




15.11.2021


Yellox







Bausch Health Ireland Limited




3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland






EU/1/11/692


2.12.2021




15.11.2021


Zercepac







Accord Healthcare S.L.U.




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






EU/1/20/1456


16.11.2021




15.11.2021


Zercepac







Accord Healthcare S.L.U.




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






EU/1/20/1456


16.11.2021




15.11.2021


Zoledronic acid Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/12/786


16.11.2021




15.11.2021


Zonisamide Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/16/1093


16.11.2021




18.11.2021


Abecma







Bristol-Myers Squibb Pharma EEIG




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






EU/1/21/1539


21.11.2021




18.11.2021


Aripiprazole Mylan Pharma







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/15/1005


19.11.2021




18.11.2021


Axumin







Blue Earth Diagnostics Ireland Ltd




6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland






EU/1/17/1186


23.11.2021




18.11.2021


Aybintio







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/20/1454


22.11.2021




18.11.2021


Beovu







Novartis Europharm Limited




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






EU/1/19/1417


26.11.2021




18.11.2021


Champix







Pfizer Europe MA EEIG




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






EU/1/06/360


19.11.2021




18.11.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


18.11.2021




18.11.2021


Marixino







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/13/820


22.11.2021




18.11.2021


Ogivri







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/18/1341


22.11.2021




18.11.2021


Opatanol







Novartis Europharm Limited




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






EU/1/02/217


19.11.2021




18.11.2021


Pemetrexed Krka







KRKA, d.d.




Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/18/1283


22.11.2021




18.11.2021


Prometax







Novartis Europharm Limited




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






EU/1/98/092


19.11.2021




18.11.2021


Ritonavir Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/17/1242


19.11.2021




18.11.2021


Steglujan







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1266


20.11.2021




18.11.2021


Tecartus







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/20/1492


19.11.2021




18.11.2021


Xagrid







Shire Pharmaceuticals Ireland Limited




Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland






EU/1/04/295


19.11.2021




18.11.2021


Xoterna Breezhaler







Novartis Europharm Limited




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






EU/1/13/863


19.11.2021




18.11.2021


Zeffix







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/99/114


19.11.2021




18.11.2021


Zeposia







Bristol-Myers Squibb Pharma EEIG




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






EU/1/20/1442


21.11.2021




19.11.2021


Aripiprazole Mylan Pharma







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/15/1005


22.11.2021




22.11.2021


Briviact







UCB Pharma S.A.




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






EU/1/15/1073


1.12.2021




22.11.2021


BYANNLI







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1453


23.11.2021




22.11.2021


Foclivia







Seqirus S.r.l.,




Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia






EU/1/09/577


23.11.2021




22.11.2021


Lacosamide Accord







Accord Healthcare S.L.U.




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






EU/1/17/1230


23.11.2021




22.11.2021


Pregabalin Zentiva k.s







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1166


23.11.2021




22.11.2021


Saxenda







Novo Nordisk A/S




Novo Allé, 2880 Bagsværd, Danmark






EU/1/15/992


23.11.2021




22.11.2021


Suliqua







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/16/1157


23.11.2021




22.11.2021


Talmanco







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/16/1153


23.11.2021




22.11.2021


TOBI Podhaler







Mylan IRE Healthcare Ltd




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






EU/1/10/652


23.11.2021




22.11.2021


Zypadhera







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/08/479


23.11.2021




23.11.2021


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


23.11.2021




26.11.2021


Clopidogrel Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/540


30.11.2021




26.11.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


26.11.2021




26.11.2021


Corbilta







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/13/859


30.11.2021




26.11.2021


Kisplyx







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/16/1128


29.11.2021




26.11.2021


Lenvima







Eisai GmbH




Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland






EU/1/15/1002


29.11.2021




26.11.2021


Lyxumia







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/12/811


29.11.2021




26.11.2021


NeoRecormon







Roche Registration GmbH




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






EU/1/97/031


1.12.2021




26.11.2021


Pritor







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/98/089


30.11.2021




26.11.2021


Relvar Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/13/886


29.11.2021




26.11.2021


Repatha







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/15/1016


29.11.2021




26.11.2021


Replagal







Shire Human Genetic Therapies AB




Lindhagensgatan 120, 112 51, Stockholm, Sverige






EU/1/01/189


6.12.2021




26.11.2021


Rivaroxaban Accord







Accord Healthcare S.L.U.




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






EU/1/20/1488


24.10.2021




26.11.2021


Rivaroxaban Accord







Accord Healthcare S.L.U.




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






EU/1/20/1488


30.11.2021




26.11.2021


Uptravi







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/15/1083


29.12.2021




29.11.2021


Carmustine Obvius







Obvius Investment B.V.




De Cuserstraat 93, 1081 CN Amsterdam, Nederland






EU/1/18/1278


1.12.2021




29.11.2021


Hirobriz Breezhaler







Novartis Europharm Limited




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






EU/1/09/594


30.11.2021




29.11.2021


IntronA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/99/127


1.12.2021




29.11.2021


Simulect







Novartis Europharm Limited




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






EU/1/98/084


30.11.2021




—   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




3.11.2021


Pregabalin Mylan Pharma







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/15/998


5.11.2021




15.11.2021


Atripla







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/07/430


16.11.2021




18.11.2021


Skysona







bluebird bio (Netherlands) B.V.




Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland






EU/1/21/1563


19.11.2021




30.11.2021


IntronA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/99/127


1.12.2021




—   Issuing 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


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




11.11.2021


Felpreva


tigolaner/emodepside/praziquantel







Vetoquinol S.A.




Magny-Vernois, 70200 Lure, France






EU/2/21/277


Spot-on solution


QP52AA51


12.11.2021




—   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




3.11.2021


Chanhold







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/19/236


5.11.2021




3.11.2021


Equilis Prequenza







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/05/056


5.11.2021




3.11.2021


Equilis Prequenza Te







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/05/057


5.11.2021




3.11.2021


Kexxtone







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/12/145


4.11.2021




11.11.2021


Cepedex







CP Pharma Handelsgesellschaft mbH




Ostlandring 13, 31303 Burgdorf, Deutschland






EU/2/16/200


25.11.2021




11.11.2021


Coliprotec F4/F18







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/16/202


15.11.2021




12.11.2021


Aivlosin







ECO Animal Health Europe Limited




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






EU/2/04/044


16.11.2021




12.11.2021


Simparica Trio







Zoetis Belgium S.A.




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






EU/2/19/243


16.11.2021




26.11.2021


PREVEXXION RN







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/254


3.12.2021




29.11.2021


NexGard Combo







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/20/267


30.11.2021




—   Withdrawal of a marketing authorisation (Article 38 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




15.11.2021


Coliprotec F4







Prevtec Microbia GmbH




Geyerspergerstr 27, 80689 München, Deutschland






EU/2/14/180


7.12.2021




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, 30.4.2004, p. 1.