Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2022 to 28 February 2022 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2022-03-31
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_2022144EN.01000101.xml










31.3.2022   


EN


Official Journal of the European Union


C 144/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2022 to 28 February 2022
(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 144/01)
—   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




14.2.2022


Apexxnar


pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)







Pfizer Europe MA EEIG




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






EU/1/21/1612


Suspension for injection


J07AL02


15.2.2022




14.2.2022


Ngenla


somatrogon







Pfizer Europe MA EEIG




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






EU/1/21/1617


Solution for injection


Pending


15.2.2022




14.2.2022


OKEDI


risperidone







Laboratorios Farmacéuticos Rovi, S.A.




Julián Camarillo 35, 28037 Madrid, España






EU/1/21/1621


Powder and solvent for prolonged-release suspension for injection


N05AX08


15.2.2022




14.2.2022


Oxbryta


voxelotor







Global Blood Therapeutics Netherlands B.V.




Strawinskylaan 3051, 1077 ZX Amsterdam, Noord-Holland, Nederland






EU/1/21/1622


Film-coated tablet


B06AX


15.2.2022




14.2.2022


Saphnelo


anifrolumab







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1623


Concentrate for solution for infusion


L04AA51


15.2.2022




16.2.2022


Kerendia


finerenone







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/21/1616


Film-coated tablet


C03DA05


17.2.2022




16.2.2022


Sapropterin Dipharma


sapropterin







Dipharma B.V.




Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland






EU/1/21/1620


Powder for oral solution
Soluble tablet


A16AX07


17.2.2022




16.2.2022


Sitagliptin/Metformin hydrochloride Mylan


sitagliptin/metformin hydrochloride







Mylan Ireland Limited




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






EU/1/21/1619


Film-coated tablet


A10BD07


21.2.2022




16.2.2022


Tepmetko


tepotinib







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/21/1596


Film-coated tablet


L01EX21


17.2.2022




21.2.2022


Ontilyv


opicapone







Bial — Portela & Ca, SA




À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal






EU/1/21/1578


Capsule, hard


N04BX04


22.2.2022




—   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




2.2.2022


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


2.2.2022




3.2.2022


Clopidogrel Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/09/568


7.2.2022




3.2.2022


DaTSCAN







GE Healthcare B.V.




De Rondom 8, 5612 AP, Eindhoven, Nederland






EU/1/00/135


9.2.2022




3.2.2022


Edarbi







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbæk Strand, Danmark






EU/1/11/734


8.2.2022




3.2.2022


Efavirenz/Emtricitabine/Tenofovir disoproxil Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/17/1263


9.2.2022




3.2.2022


Nyxoid







Mundipharma Corporation (Ireland) Limited




Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland






EU/1/17/1238


7.2.2022




3.2.2022


Pregabalin Zentiva







Zentiva, k.s.




U Kabelovny 130, 102 37 Praha 10, Česká republika






EU/1/15/1021


8.2.2022




3.2.2022


Vivanza







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/03/249


7.2.2022




3.2.2022


Voriconazole Accord







Accord Healthcare S.L.U.




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






EU/1/13/835


4.2.2022




3.2.2022


Xigduo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/13/900


4.2.2022




4.2.2022


Cialis







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/02/237


8.2.2022




4.2.2022


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


4.2.2022




4.2.2022


Ebixa







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/02/219


8.2.2022




4.2.2022


Ebymect







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/15/1051


7.2.2022




4.2.2022


Entacapone Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/10/665


8.2.2022




4.2.2022


HyQvia







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/13/840


7.2.2022




4.2.2022


Iressa







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/09/526


7.2.2022




4.2.2022


Neupro







UCB Pharma S.A.




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






EU/1/05/331


9.2.2022




4.2.2022


Noxafil







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/05/320


8.2.2022




4.2.2022


Plegridy







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/14/934


9.2.2022




4.2.2022


Revolade







Novartis Europharm Limited




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






EU/1/10/612


7.2.2022




4.2.2022


Roclanda







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/20/1502


10.2.2022




4.2.2022


Sivextro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/991


8.2.2022




4.2.2022


Temozolomide Accord







Accord Healthcare S.L.U.




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






EU/1/10/615


9.2.2022




4.2.2022


Vantobra







PARI Pharma GmbH




Moosstraße 3, 82319 Starnberg, Deutschland






EU/1/18/1350


10.2.2022




4.2.2022


Yellox







BAUSCH + LOMB IRELAND LIMITED




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






EU/1/11/692


14.2.2022




4.2.2022


Zoledronic acid Hospira







Pfizer Europe MA EEIG




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






EU/1/12/800


7.2.2022




10.2.2022


Ameluz







Biofrontera Bioscience GmbH




Hemmelrather Weg 201, 51377 Leverkusen, Deutschland






EU/1/11/740


15.2.2022




10.2.2022


Axumin







Blue Earth Diagnostics Ireland Ltd




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






EU/1/17/1186


15.2.2022




10.2.2022


Cotellic







Roche Registration GmbH




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






EU/1/15/1048


14.2.2022




10.2.2022


Nityr







Cycle Pharmaceuticals (Europe) Ltd




70 Sir John Rogerson’s Quay, Dublin 2, Ireland






EU/1/18/1290


15.2.2022




10.2.2022


Wakix







Bioprojet Pharma




9 rue Rameau, 75002 Paris, France






EU/1/15/1068


3.3.2022




14.2.2022


Cubicin







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/05/328


18.2.2022




14.2.2022


Incruse Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/922


4.3.2022




14.2.2022


Ivabradine Accord







Accord Healthcare S.L.U.




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






EU/1/17/1190


15.2.2022




14.2.2022


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle Monte Esquinza 30, 28010 Madrid, España






EU/1/20/1507


16.2.2022




14.2.2022


Waylivra







Akcea Therapeutics Ireland Limited




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






EU/1/19/1360


21.2.2022




14.2.2022


Xromi







Nova Laboratories Ireland Limited




3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland






EU/1/19/1366


17.2.2022




16.2.2022


AMGLIDIA







AMMTeK




55 rue de Turbigo, 75003 Paris, France






EU/1/18/1279


16.2.2022




16.2.2022


Besponsa







Pfizer Europe MA EEIG




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






EU/1/17/1200


17.2.2022




16.2.2022


CellCept







Roche Registration GmbH




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






EU/1/96/005


17.2.2022




16.2.2022


Deltyba







Otsuka Novel Products GmbH




Erika-Mann-Straße 21, 80636 München, Deutschland






EU/1/13/875


17.2.2022




16.2.2022


Eliquis







Bristol-Myers Squibb/Pfizer EEIG




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






EU/1/11/691


17.2.2022




16.2.2022


ellaOne







Laboratoire HRA Pharma




200 avenue de Paris, 92320 Chatillon, France






EU/1/09/522


23.2.2022




16.2.2022


Envarsus







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/14/935


21.2.2022




16.2.2022


Febuxostat Mylan







Mylan Pharmaceuticals Limited




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






EU/1/17/1194


17.2.2022




16.2.2022


JEMPERLI







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/21/1538


17.2.2022




16.2.2022


Laventair Ellipta







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/14/899


4.3.2022




16.2.2022


Mayzent







Novartis Europharm Limited




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






EU/1/19/1414


17.2.2022




16.2.2022


Modigraf







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/09/523


17.2.2022




16.2.2022


Myclausen







Passauer Pharma GmbH




Eiderstedter Weg 3, 14129 Berlin, Deutschland






EU/1/10/647


17.2.2022




16.2.2022


Pemazyre







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1535


21.2.2022




16.2.2022


Pregabalin Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1011


21.2.2022




16.2.2022


Riximyo







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1184


17.2.2022




16.2.2022


Temybric Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/19/1378


4.3.2022




16.2.2022


Yuflyma







Celltrion Healthcare Hungary Kft.




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






EU/1/20/1513


2.3.2022




16.2.2022


Zykadia







Novartis Europharm Limited




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






EU/1/15/999


17.2.2022




17.2.2022


Advagraf







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/07/387


21.2.2022




17.2.2022


Avonex







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/97/033


23.2.2022




17.2.2022


Mycophenolate mofetil Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/439


18.2.2022




17.2.2022


Myfenax







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/07/438


21.2.2022




17.2.2022


Nexium Control







GlaxoSmithKline Dungarvan Limited




Dungarvan, Co. Waterford, Ireland






EU/1/13/860


24.2.2022




18.2.2022


Tarceva







Roche Registration GmbH




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






EU/1/05/311


21.2.2022




18.2.2022


Zelboraf







Roche Registration GmbH




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






EU/1/12/751


21.2.2022




21.2.2022


Clopidogrel Taw Pharma







Taw Pharma (Ireland) Limited




104 Lower Baggot Street, Dublin 2, Ireland






EU/1/09/559


22.2.2022




21.2.2022


Jardiance







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/930


25.2.2022




21.2.2022


Ogivri







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/18/1341


23.2.2022




21.2.2022


Refixia







Novo Nordisk A/S




Novo Allé, 2880 Bagsværd, Danmark






EU/1/17/1193


24.2.2022




21.2.2022


Skilarence







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/17/1201


23.2.2022




23.2.2022


Tecentriq







Roche Registration GmbH




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






EU/1/17/1220


25.2.2022




24.2.2022


ADVATE







Takeda Manufacturing Austria AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/03/271


28.2.2022




24.2.2022


Bortezomib Hospira







Pfizer Europe MA EEIG




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






EU/1/16/1114


25.2.2022




24.2.2022


Briviact







UCB Pharma S.A.




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






EU/1/15/1073


25.2.2022




24.2.2022


Irbesartan Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/576


28.2.2022




24.2.2022


JEVTANA







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/11/676


28.2.2022




24.2.2022


Lacosamide UCB







UCB Pharma S.A.




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






EU/1/19/1383


25.2.2022




24.2.2022


Rixathon







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1185


25.2.2022




24.2.2022


Senshio







Shionogi B.V.




Kingsfordweg 151, 1043 GR Amsterdam, Nederland






EU/1/14/978


25.2.2022




28.2.2022


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


28.2.2022




28.2.2022


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


2.3.2022




28.2.2022


Nimenrix







Pfizer Europe MA EEIG




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






EU/1/12/767


1.3.2022




28.2.2022


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


2.3.2022




28.2.2022


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


1.3.2022




—   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




3.2.2022


Vivanza







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/03/249


7.2.2022




—   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




1.2.2022


Bravecto







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/13/158


3.2.2022




1.2.2022


Mirataz







Dechra Regulatory B.V.




Handelsweg 25, 5531 AE Bladel, Nederland






EU/2/19/247


2.2.2022




8.2.2022


Exzolt







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/212


9.2.2022




8.2.2022


Zulvac 8 Ovis







Zoetis Belgium S.A.




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






EU/2/09/104


9.2.2022




10.2.2022


Draxxin







Zoetis Belgium S.A.




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






EU/2/03/041


16.2.2022




10.2.2022


Nobilis IB 4-91







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/98/006


14.2.2022




10.2.2022


Onsior







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/08/089


11.2.2022




28.2.2022


Innovax-ND-IBD







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/17/213


2.3.2022




28.2.2022


Innovax-ND-ILT







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/20/256


2.3.2022




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.