Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2021 to 30 September 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2021-10-29
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








C_2021441EN.01000101.xml










29.10.2021   


EN


Official Journal of the European Union


C 441/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2021 to 30 September 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 441/01)
—   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




16.9.2021


Cometriq


cabozantinib







Ipsen Pharma




65 quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/13/890


Capsule, hard


L01EX07


22.9.2021




22.9.2021


Imatinib Koanaa


imatinib







Koanaa Healthcare GmbH




Fehrgasse 7, 2401 Fischamend, Österreich






EU/1/21/1568


Oral solution


L01EA01


24.9.2021




—   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




1.9.2021


Deferasirox Mylan







Mylan Pharmaceuticals Limited




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






EU/1/19/1386


2.9.2021




1.9.2021


Herceptin







Roche Registration GmbH




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






EU/1/00/145


29.9.2021




1.9.2021


Repaglinide Accord







Accord Healthcare S.L.U.




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






EU/1/11/743


2.9.2021




1.9.2021


Ultomiris







Alexion Europe SAS




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






EU/1/19/1371


2.9.2021




1.9.2021


ZINPLAVA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/16/1156


3.9.2021




3.9.2021


COVID-19 Vaccine Janssen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


6.9.2021




6.9.2021


Riluzole Zentiva







Zentiva k.s.




U kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/12/768


7.9.2021




6.9.2021


Ristfor







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/10/620


7.9.2021




14.9.2021


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


14.9.2021




15.9.2021


Amlodipine/Valsartan Mylan







Mylan Pharmaceuticals Limited




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






EU/1/16/1092


17.9.2021




15.9.2021


Cystadrops







Recordati Rare Diseases




Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France






EU/1/15/1049


28.9.2021




15.9.2021


Emtricitabine/Tenofovir disoproxil Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/16/1151


16.9.2021




15.9.2021


Exjade







Novartis Europharm Limited




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






EU/1/06/356


16.9.2021




15.9.2021


Fulphila







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/18/1329


23.9.2021




15.9.2021


Janumet







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/08/455


17.9.2021




15.9.2021


Resolor







Takeda Pharmaceuticals International AG Ireland Branch




Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland






EU/1/09/581


16.9.2021




15.9.2021


TachoSil







Corza Medical GmbH




Speditionsstraße 21, 40221 Düsseldorf, Deutschland






EU/1/04/277


16.9.2021




15.9.2021


Tadalafil Mylan







Mylan Pharmaceuticals Limited




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






EU/1/14/961


23.9.2021




16.9.2021


ADCETRIS







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/12/794


20.9.2021




16.9.2021


Darunavir Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1140


17.9.2021




16.9.2021


Deltyba







Otsuka Novel Products GmbH




Erika-Mann-Straße 21, 80636 München, Deutschland






EU/1/13/875


17.9.2021




16.9.2021


Elebrato Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1237


17.9.2021




16.9.2021


Epivir







ViiV Healthcare B.V.




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






EU/1/96/015


20.9.2021




16.9.2021


Exviera







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/14/983


20.9.2021




16.9.2021


Infanrix hexa







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/00/152


21.9.2021




16.9.2021


Lenalidomide Accord







Accord Healthcare S.L.U.




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






EU/1/18/1316


17.9.2021




16.9.2021


Lenalidomide Mylan







Mylan Ireland Limited




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






EU/1/20/1490


23.9.2021




16.9.2021


Movymia







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/16/1161


17.9.2021




16.9.2021


Parsabiv







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/16/1142


20.9.2021




16.9.2021


Revlimid







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/391


21.9.2021




16.9.2021


Rubraca







Clovis Oncology Ireland Limited




Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland






EU/1/17/1250


20.9.2021




16.9.2021


SomaKit TOC







Advanced Accelerator Applications




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






EU/1/16/1141


20.9.2021




16.9.2021


Terrosa







Gedeon Richter Plc.




Gyömrői út 19-21, 1103 Budapest, Magyarország






EU/1/16/1159


29.9.2021




16.9.2021


Trelegy Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1236


17.9.2021




16.9.2021


Vosevi







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/17/1223


20.9.2021




16.9.2021


Zynteglo







bluebird bio (Netherlands) B.V.




Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland






EU/1/19/1367


17.9.2021




22.9.2021


AJOVY







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/19/1358


23.9.2021




22.9.2021


Anagrelide Mylan







Mylan Pharmaceuticals Limited




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






EU/1/17/1256


29.9.2021




22.9.2021


Azilect







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/04/304


23.9.2021




22.9.2021


BeneFIX







Pfizer Europe MA EEIG




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






EU/1/97/047


23.9.2021




22.9.2021


Constella







Allergan Pharmaceuticals International Limited




Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland






EU/1/12/801


4.10.2021




22.9.2021


Defitelio







Gentium S.r.I.




Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia






EU/1/13/878


5.10.2021




22.9.2021


Docetaxel Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/611


24.9.2021




22.9.2021


Emtricitabine/Tenofovir disoproxil Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/16/1133


27.9.2021




22.9.2021


Febuxostat Mylan







Mylan Pharmaceuticals Limited




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






EU/1/17/1194


27.9.2021




22.9.2021


Hepcludex







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1446


23.9.2021




22.9.2021


Insulatard







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/02/233


23.9.2021




22.9.2021


Intuniv







Takeda Pharmaceuticals International AG Ireland Branch




Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland






EU/1/15/1040


23.9.2021




22.9.2021


Mepsevii







Ultragenyx Germany GmbH




Rahel-Hirsch-Str. 10, 10557 Berlin, Deutschland






EU/1/18/1301


23.9.2021




22.9.2021


Mixtard







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/02/231


26.9.2021




22.9.2021


NovoRapid







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/99/119


23.9.2021




22.9.2021


Protaphane







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/02/234


23.9.2021




22.9.2021


Telmisartan Actavis







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/10/639


23.9.2021




22.9.2021


Triumeq







ViiV Healthcare BV




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






EU/1/14/940


23.9.2021




22.9.2021


Viekirax







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/14/982


23.9.2021




22.9.2021


Vihuma







Octapharma AB




Lars Forssells gata 23, 112 75 Stockholm, Sverige






EU/1/16/1168


28.9.2021




22.9.2021


Volibris







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/08/451


23.9.2021




22.9.2021


Xultophy







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/14/947


23.9.2021




22.9.2021


Zoledronic acid Actavis







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/12/759


23.9.2021




22.9.2021


Zoledronic acid Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/12/786


5.10.2021




23.9.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


23.9.2021




23.9.2021


Grastofil







Accord Healthcare S.L.U.




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






EU/1/13/877


27.9.2021




23.9.2021


Levemir







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/04/278


26.9.2021




23.9.2021


Liprolog







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/01/195


27.9.2021




23.9.2021


Rasagiline ratiopharm







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/14/977


24.9.2021




23.9.2021


Rezolsta







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/14/967


24.9.2021




23.9.2021


Rivastigmine 1 A Pharma







1 A Pharma GmbH




Keltenring 1 + 3, 82041 Oberhaching, Deutschland






EU/1/09/585


27.9.2021




23.9.2021


Zoledronic acid Accord







Accord Healthcare S.L.U.




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






EU/1/13/834


27.9.2021




29.9.2021


Adakveo







Novartis Europharm Limited




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






EU/1/20/1476


30.9.2021




29.9.2021


Ambrisentan Mylan







Mylan Pharmaceuticals Limited




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






EU/1/19/1368


1.10.2021




29.9.2021


Atazanavir Mylan







Mylan Pharmaceuticals Limited




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






EU/1/16/1091


30.9.2021




29.9.2021


Brilique







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/10/655


1.10.2021




29.9.2021


Cinacalcet Mylan







Mylan Pharmaceuticals Limited




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






EU/1/15/1054


1.10.2021




29.9.2021


COVID-19 Vaccine Janssen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


29.9.2021




29.9.2021


Duloxetine Mylan







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/15/1010


30.9.2021




29.9.2021


Duloxetine Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/15/1028


30.9.2021




29.9.2021


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan







Mylan Pharmaceuticals Limited




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






EU/1/17/1222


30.9.2021




29.9.2021


Entacapone Orion







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/11/708


1.10.2021




29.9.2021


Imatinib Accord







Accord Healthcare S.L.U.




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






EU/1/13/845


1.10.2021




29.9.2021


Ivabradine Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/16/1144


30.9.2021




29.9.2021


Lamivudine / Zidovudine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/10/663


1.10.2021




29.9.2021


Nevirapine Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/598


1.10.2021




29.9.2021


NovoSeven







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/96/006


1.10.2021




29.9.2021


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/06/380


4.10.2021




29.9.2021


Ryzodeg







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/12/806


1.10.2021




29.9.2021


Sildenafil ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/09/603


4.10.2021




29.9.2021


Sildenafil Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/584


1.10.2021




29.9.2021


Symtuza







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/17/1225


30.9.2021




29.9.2021


TAKHZYRO







Takeda Pharmaceuticals International AG Ireland Branch




Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland






EU/1/18/1340


30.9.2021




29.9.2021


Tresiba







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/12/807


1.10.2021




29.9.2021


Vemlidy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1154


30.9.2021




29.9.2021


Zalviso







FGK Representative Service GmbH




Heimeranstraße 35, 80339 München, Deutschland






EU/1/15/1042


4.10.2021




29.9.2021


Zydelig







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/14/938


30.9.2021




—   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




16.9.2021


Halagon







Emdoka bvba




J. Lijsenstraat 16, 2321 Hoogstraten, België






EU/2/16/201


17.9.2021




16.9.2021


Nobivac L4







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/12/143


18.9.2021




16.9.2021


Respiporc Flu3







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/09/103


17.9.2021




28.9.2021


Inflacam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/11/134


4.10.2021




28.9.2021


Rheumocam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/07/078


4.10.2021




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.