Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2021 to 31 December 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2022-01-31
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_2022050EN.01000101.xml










31.1.2022   


EN


Official Journal of the European Union


C 50/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2021 to 31 December 2021
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2022/C 50/01)
—   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




9.12.2021


Cibinqo


abrocitinib







Pfizer Europe MA EEIG




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






EU/1/21/1593


Film-coated tablet


D11AH


10.12.2021




9.12.2021


Rybrevant


amivantamab







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/21/1594


Concentrate for solution for infusion


L01FX18


10.12.2021




9.12.2021


Sitagliptin SUN


sitagliptin fumarate







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87, 2132 JH Hoofddorp, Nederland






EU/1/21/1598


Film-coated tablet


A10BH01


15.12.2021




13.12.2021


ASPAVELI


pegcetacoplan







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/21/1595


Solution for infusion


L04AA54


14.12.2021




13.12.2021


Vaxneuvance


Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/21/1591


Suspension for injection


J07AL


14.12.2021




17.12.2021


Xevudy


sotrovimab







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1562


Concentrate for solution for infusion


Pending


17.12.2021




20.12.2021


Nuvaxovid


COVID-19 Vaccine (recombinant, adjuvanted)







Novavax CZ, a.s.




Bohumil 138, 281 63 Jevany, Česká republika






EU/1/21/1618


dispersion for injection


J07BX03


20.12.2021




—   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




2.12.2021


Cimzia







UCB Pharma S.A.




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






EU/1/09/544


3.12.2021




2.12.2021


Ebilfumin







Actavis Group PTC ehf.




Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland






EU/1/14/915


7.12.2021




2.12.2021


Ivozall







ORPHELIA Pharma SAS




85 boulevard Saint-Michel, 75005 Paris, France






EU/1/19/1396


7.12.2021




2.12.2021


Kaletra







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/01/172


3.12.2021




2.12.2021


Revinty Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/929


3.12.2021




3.12.2021


Kiovig







Baxter AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/05/329


6.12.2021




3.12.2021


Lojuxta







Amryt Pharmaceuticals DAC




45 Mespil Road, Dublin 4, Ireland






EU/1/13/851


15.12.2021




3.12.2021


Naglazyme







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork P43 R298, Ireland






EU/1/05/324


11.1.2022




3.12.2021


Ocrevus







Roche Registration GmbH




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






EU/1/17/1231


6.12.2021




3.12.2021


Polivy







Roche Registration GmbH




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






EU/1/19/1388


7.12.2021




3.12.2021


Xagrid







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/04/295


6.12.2021




6.12.2021


RoActemra







Roche Registration GmbH




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






EU/1/08/492


7.12.2021




7.12.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


7.12.2021




8.12.2021


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle Monte Esquinza 30, 28010 Madrid, España






EU/1/20/1507


8.12.2021




9.12.2021


ADCETRIS







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbæk Strand, Danmark






EU/1/12/794


14.12.2021




9.12.2021


AMGEVITA







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/16/1164


13.12.2021




9.12.2021


Amyvid







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/12/805


13.12.2021




9.12.2021


Apealea







Inceptua AB




Gustavslundsv. 143, 16751 Bromma, Sverige






EU/1/18/1292


10.12.2021




9.12.2021


Chenodeoxycholic acid Leadiant







Leadiant GmbH




Liebherrstr. 22, 80538 Munich, Deutschland






EU/1/16/1110


10.12.2021




9.12.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


10.12.2021




9.12.2021


Dengvaxia







Sanofi Pasteur




14 Espace Henry Vallée, 69007 Lyon, France






EU/1/18/1338


13.12.2021




9.12.2021


Erleada







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/18/1342


10.12.2021




9.12.2021


Esbriet







Roche Registration GmbH




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






EU/1/11/667


10.12.2021




9.12.2021


Exelon







Novartis Europharm Limited




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






EU/1/98/066


10.12.2021




9.12.2021


Holoclar







Holostem Terapie Avanzate S.r.l.




Via Glauco Gottardi 100, Modena, MO 41125, Italia






EU/1/14/987


13.12.2021




9.12.2021


JETREA







Inceptua AB




Gustavslundsv. 143, 16751 Bromma, Sverige






EU/1/13/819


10.12.2021




9.12.2021


Leganto







UCB Pharma S.A.




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






EU/1/11/695


10.12.2021




9.12.2021


Livogiva







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/20/1462


13.12.2021




9.12.2021


Ogluo







Tetris Pharma B.V




Element Offices, Bargelaan 180-200, 2333 CW, Leiden, Nederland






EU/1/20/1523


13.12.2021




9.12.2021


Pioglitazone Accord







Accord Healthcare S.L.U.




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






EU/1/11/722


10.12.2021




9.12.2021


Pradaxa







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/08/442


14.12.2021




9.12.2021


Roteas







Berlin-Chemie AG




Glienicker Weg 125, 12489 Berlin, Deutschland






EU/1/16/1152


15.12.2021




9.12.2021


Stalevo







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/03/260


10.12.2021




9.12.2021


Thalidomide BMS







Bristol-Myers Squibb Pharma EEIG




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






EU/1/08/443


10.12.2021




9.12.2021


Xospata







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/19/1399


10.12.2021




9.12.2021


ZALTRAP







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/12/814


10.12.2021




9.12.2021


Zyprexa







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/96/022


13.12.2021




9.12.2021


Zyprexa Velotab







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/99/125


13.12.2021




13.12.2021


ADCETRIS







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/12/794


14.12.2021




13.12.2021


Conbriza







Pfizer Europe MA EEIG




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






EU/1/09/511


14.12.2021




13.12.2021


Giotrif







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/13/879


14.12.2021




13.12.2021


Invanz







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/02/216


14.12.2021




13.12.2021


Kanuma







Alexion Europe SAS




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






EU/1/15/1033


14.12.2021




13.12.2021


Kinzalmono







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/98/091


14.12.2021




13.12.2021


Mycophenolate mofetil Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/439


14.12.2021




13.12.2021


Neulasta







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/02/227


15.12.2021




13.12.2021


Neuraceq







Life Radiopharma Berlin GmbH




Max-Planck-Straße 4, 12489 Berlin, Deutschland






EU/1/13/906


15.12.2021




13.12.2021


NULOJIX







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/694


14.12.2021




13.12.2021


Pramipexole Accord







Accord Healthcare S.L.U.




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






EU/1/11/728


16.12.2021




13.12.2021


Pramipexole Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/08/490


17.12.2021




13.12.2021


Rapiscan







GE Healthcare AS




Nycoveien 1, 0485, Oslo, Norge






EU/1/10/643


15.12.2021




13.12.2021


Rebif







Merck Europe B.V.




Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland






EU/1/98/063


17.12.2021




13.12.2021


Rivastigmine Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/09/599


15.12.2021




13.12.2021


Thalidomide BMS







Bristol-Myers Squibb Pharma EEIG




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






EU/1/08/443


14.12.2021




13.12.2021


Xofigo







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/13/873


15.12.2021




16.12.2021


Ceprotin







Baxter AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/01/190


17.12.2021




16.12.2021


Cinacalcet Accordpharma







Accord Healthcare S.L.U.




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






EU/1/20/1429


17.12.2021




16.12.2021


Clopidogrel Krka d.d.







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/562


20.12.2021




16.12.2021


Clopidogrel Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/08/465


23.12.2021




16.12.2021


COVID-19 Vaccine Janssen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


16.12.2021




16.12.2021


Dexdor







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/11/718


19.12.2021




16.12.2021


Grepid







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/09/535


17.12.2021




16.12.2021


Herzuma







Celltrion Healthcare Hungary Kft.




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






EU/1/17/1257


20.12.2021




16.12.2021


Humira







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/03/256


17.12.2021




16.12.2021


Jyseleca







Galapagos NV




Generaal De Wittelaan L11 A3, 2800 Mechelen Antwerp, België






EU/1/20/1480


17.12.2021




16.12.2021


KANJINTI







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/18/1281


20.12.2021




16.12.2021


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


20.12.2021




16.12.2021


Revestive







Shire Pharmaceuticals Ireland Limited




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






EU/1/12/787


23.12.2021




16.12.2021


Rinvoq







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/19/1404


17.12.2021




16.12.2021


Sarclisa







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/20/1435


17.12.2021




16.12.2021


Siklos







Addmedica




37 rue de Caumartin, 75009 Paris, France






EU/1/07/397


17.12.2021




16.12.2021


Vemlidy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1154


17.12.2021




16.12.2021


Vocabria







ViiV Healthcare BV




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






EU/1/20/1481


17.12.2021




16.12.2021


Zoely







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/11/690


21.12.2021




16.12.2021


Zoely







Theramex Ireland Limited




3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland






EU/1/11/690


21.12.2021




17.12.2021


Kineret







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/02/203


17.12.2021




20.12.2021


Intuniv







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/15/1040


21.12.2021




20.12.2021


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


21.12.2021




20.12.2021


PANTOLOC Control







Takeda GmbH




Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland






EU/1/09/519


21.12.2021




20.12.2021


Raloxifene Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/10/627


23.12.2021




20.12.2021


Selincro







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/12/815


21.12.2021




20.12.2021


Veklury







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/20/1459


20.12.2021




20.12.2021


Voriconazole Hikma







Hikma Farmacêutica (Portugal), S.A.




Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal






EU/1/15/1004


4.1.2022




—   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




13.12.2021


Leganto







UCB Pharma S.A.




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






EU/1/11/695


4.1.2022




20.12.2021


PANTOLOC Control







Takeda GmbH




Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland






EU/1/09/519


21.12.2021




20.12.2021


Rasilez HCT







Noden Pharma DAC




D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland






EU/1/08/491


22.12.2021




20.12.2021


Ytracis







CIS bio international




Boite Postale 32, 91192 Gif-sur-Yvette, France






EU/1/03/250


22.12.2021




—   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




7.12.2021


Imoxat


imidacloprid/moxidectin







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, Ireland






EU/2/21/280


Spot-on solution


QP54AB52


9.12.2021




7.12.2021


Suiseng Diff/A


Clostridioides difficile and Clostridium perfringens vaccine, inactivated







Laboratorios Hipra, S.A.




Avda. La Selva, 135, 17170 Amer (Girona), España






EU/2/21/278


Suspension for injection


QI09AB12


9.12.2021




15.12.2021


Zenalpha


medetomidine hydrochloride/vatinoxan hydrochloride







Vetcare Oy




P.O. Box 99, 24101 Salo, Suomi






EU/2/21/279


Solution for injection


QN05CM99


16.12.2021




—   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




7.12.2021


Circovac







CEVA-Phylaxia Co. Ltd




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/07/075


9.12.2021




7.12.2021


Stronghold Plus







Zoetis Belgium S.A.




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






EU/2/16/204


13.12.2021




13.12.2021


Apoquel







Zoetis Belgium S.A.




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






EU/2/13/154


15.12.2021




15.12.2021


Bravecto Plus







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/18/224


16.12.2021




15.12.2021


Cardalis







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/12/142


16.12.2021




15.12.2021


Osurnia







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/14/170


16.12.2021




15.12.2021


Rabitec







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/17/219


16.12.2021




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.