Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2022 to 31 January 2022 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2022-02-28
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_2022096EN.01000601.xml










28.2.2022   


EN


Official Journal of the European Union


C 96/6






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2022 to 31 January 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 96/02)
—   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




6.1.2022


Lumykras


sotorasib







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/21/1603


Film-coated tablet


L01XX73


7.1.2022




6.1.2022


Riltrava Aerosphere


formoterol / glycopyrronium bromide / budesonide







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1604


Pressurised inhalation, suspension


R03AL11


7.1.2022




6.1.2022


Tecovirimat SIGA


tecovirimat







SIGA Technologies Netherlands B.V.




Prinsenhil 29, Breda 4825 AX, Nederland






EU/1/21/1600


Capsule, hard


J05AX24


7.1.2022




6.1.2022


Wegovy


semaglutide







Novo Nordisk A/S




Novo Allé, 2880 Bagsværd, Danmark






EU/1/21/1608


Solution for injection


A10BJ06


7.1.2022




11.1.2022


Lonapegsomatropin Ascendis Pharma


Lonapegsomatropin







Ascendis Pharma Endocrinology Division A/S




Tuborg Boulevard 12, 2900 Hellerup, Danmark






EU/1/21/1607


Powder and solvent for solution for injection


Pending


17.1.2022




11.1.2022


Tavneos


avacopan







Vifor Fresenius Medical Care Renal Pharma France




100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France






EU/1/21/1605


Capsule, hard


Pending


19.1.2022




11.1.2022


Voraxaze


glucarpidase







SERB SAS




40 Avenue George V, 75008 Paris, France






EU/1/21/1586


Powder for solution for injection


V03AF09


13.1.2022




24.1.2022


Vyepti


eptinezumab







H. Lundbeck A/S




Ottiliavej 9, 2500 Valby, Danmark






EU/1/21/1599


Concentrate for solution for infusion


N02CD05


25.1.2022




—   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




6.1.2022


Nouryant







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






—


11.1.2022




—   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




3.1.2022


COVID-19 Vaccine Janssen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


4.1.2022




6.1.2022


ADYNOVI







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/17/1247


7.1.2022




6.1.2022


Arsenic trioxide Mylan







Mylan Ireland Limited




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






EU/1/20/1427


7.1.2022




6.1.2022


Bavencio







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/17/1214


10.1.2022




6.1.2022


Braftovi







Pierre Fabre Médicament




Les Cauquillous, 81500 Lavaur, France






EU/1/18/1314


10.1.2022




6.1.2022


CRYSVITA







Kyowa Kirin Holdings B.V.




Bloemlaan 2, 2132 NP Hoofddorp, Nederland






EU/1/17/1262


12.1.2022




6.1.2022


Darzalex







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/16/1101


7.1.2022




6.1.2022


Dupixent







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/17/1229


7.1.2022




6.1.2022


Elocta







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/15/1046


10.1.2022




6.1.2022


Emtricitabine /Tenofovir disoproxil Krka d.d.







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/17/1182


12.1.2022




6.1.2022


Ferriprox







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/99/108


3.2.2022




6.1.2022


Inhixa







Techdow Pharma Netherlands B.V.




Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland






EU/1/16/1132


18.1.2022




6.1.2022


Metalyse







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/00/169


11.1.2022




6.1.2022


Noxafil







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/05/320


10.1.2022




6.1.2022


Nuwiq







Octapharma AB




Lars Forssells gata 23, 112 75 Stockholm, Sverige






EU/1/14/936


10.1.2022




6.1.2022


Qarziba







EUSA Pharma (Netherlands) B.V.




Beechavenue 54, 1119PW Schiphol-Rijk, Nederland






EU/1/17/1191


12.1.2022




6.1.2022


Sirturo







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/13/901


7.1.2022




6.1.2022


Tecfidera







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/13/837


7.1.2022




6.1.2022


Trydonis







Chiesi Farmaceutici S.p.A.




Via Palermo 26/A, 43122 Parma, Italia






EU/1/18/1274


7.1.2022




6.1.2022


Vfend







Pfizer Europe MA EEIG




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






EU/1/02/212


7.1.2022




6.1.2022


Zytiga







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/11/714


7.1.2022




7.1.2022


Epclusa







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/16/1116


10.1.2022




7.1.2022


Kaftrio







Vertex Pharmaceuticals (Ireland) Limited




28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland






EU/1/20/1468


10.1.2022




7.1.2022


Kalydeco







Vertex Pharmaceuticals (Ireland) Limited




28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland






EU/1/12/782


10.1.2022




7.1.2022


Ledaga







Helsinn Birex Pharmaceuticals Ltd.




Damastown, Mulhuddart, Dublin 15, Ireland






EU/1/16/1171


10.1.2022




7.1.2022


LIBTAYO







Regeneron Ireland Designated Activity Company (DAC)




One Warrington Place, Dublin 2, D02 HH27 Ireland






EU/1/19/1376


11.1.2022




7.1.2022


Rolufta Ellipta







GlaxoSmithKline Trading Services Limited




Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland






EU/1/17/1174


11.1.2022




7.1.2022


YERVOY







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/698


13.1.2022




11.1.2022


Caprelsa







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/11/749


13.1.2022




11.1.2022


elmiron







bene-Arzneimittel GmbH




Herterichstraße 1-3, 81479 München, Deutschland






EU/1/17/1189


12.1.2022




11.1.2022


Ozempic







Novo Nordisk A/S




Novo Allé, 2880 Bagsværd, Danmark






EU/1/17/1251


12.1.2022




11.1.2022


Yargesa







Piramal Critical Care B.V.




Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland






EU/1/17/1176


13.1.2022




12.1.2022


Multaq







Sanofi-Aventis groupe




54 rue La Boétie, 75008 Paris, France






EU/1/09/591


13.1.2022




12.1.2022


Ocaliva







Intercept Pharma International Limited




Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland






EU/1/16/1139


13.1.2022




14.1.2022


COVID-19 Vaccine Janssen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


14.1.2022




14.1.2022


Lonquex







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/13/856


18.1.2022




14.1.2022


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


14.1.2022




20.1.2022


Abecma







Bristol-Myers Squibb Pharma EEIG




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






EU/1/21/1539


21.1.2022




20.1.2022


Cosentyx







Novartis Europharm Limited




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






EU/1/14/980


24.1.2022




20.1.2022


Inhixa







Techdow Pharma Netherlands B.V.




Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland






EU/1/16/1132


21.1.2022




20.1.2022


Lumigan







Allergan Pharmaceuticals Ireland




Castlebar Road, Westport, County Mayo, Ireland






EU/1/02/205


25.1.2022




20.1.2022


Plenadren







Takeda Pharmaceuticals International AG Ireland Branch




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






EU/1/11/715


24.1.2022




20.1.2022


Pradaxa







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/08/442


24.1.2022




20.1.2022


Yescarta







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/18/1299


21.1.2022




24.1.2022


Bridion







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/08/466


25.1.2022




24.1.2022


Cinryze







Shire Services BVBA




rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België






EU/1/11/688


25.1.2022




24.1.2022


Circadin







RAD Neurim Pharmaceuticals EEC SARL




4 rue de Marivaux, 75002 Paris, France






EU/1/07/392


26.1.2022




24.1.2022


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


24.1.2022




24.1.2022


Exjade







Novartis Europharm Limited




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






EU/1/06/356


25.1.2022




24.1.2022


Fotivda







EUSA Pharma (Netherlands) B.V.




Beechavenue 54, 1119PW Schiphol-Rijk, Nederland






EU/1/17/1215


28.1.2022




24.1.2022


Javlor







PIERRE FABRE MEDICAMENT




Les Cauquillous, 81500 Lavaur, France






EU/1/09/550


25.1.2022




24.1.2022


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


25.1.2022




24.1.2022


Kymriah







Novartis Europharm Limited




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






EU/1/18/1297


25.1.2022




24.1.2022


Lokelma







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/17/1173


25.1.2022




24.1.2022


NUCEIVA







Evolus Pharma B.V.




Apollolaan 151, 1077 AR Amsterdam, Nederland






EU/1/19/1364


7.2.2022




24.1.2022


Oslif Breezhaler







Novartis Europharm Limited




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






EU/1/09/586


25.1.2022




24.1.2022


Pregabalin Sandoz GmbH







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1012


25.1.2022




24.1.2022


Tecartus







Kite Pharma EU B.V.




Tufsteen 1, 2132 NT Hoofddorp, Nederland






EU/1/20/1492


25.1.2022




24.1.2022


Teysuno







Nordic Group B.V.




Siriusdreef 41, 2132 WT Hoofddorp, Nederland






EU/1/11/669


26.1.2022




24.1.2022


Ultibro Breezhaler







Novartis Europharm Limited




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






EU/1/13/862


25.1.2022




24.1.2022


Vizarsin







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/551


26.1.2022




24.1.2022


Zynquista







Guidehouse Germany GmbH




Albrechtstrasse 10c, 10117 Berlin, Deutschland






EU/1/19/1363


29.1.2022




25.1.2022


Actraphane







Novo Nordisk A/S




Novo Allé, 2880 Bagsværd, Danmark






EU/1/02/229


31.1.2022




25.1.2022


Actrapid







Novo Nordisk A/S




Novo Allé, 2880 Bagsværd, Danmark






EU/1/02/230


26.1.2022




25.1.2022


Fasenra







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/17/1252


27.1.2022




25.1.2022


Lantus







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/00/134


26.1.2022




25.1.2022


Prolia







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/10/618


27.1.2022




25.1.2022


Sixmo







L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A




Strada Statale 67, 50018 Scandicci (Firenze), Italia






EU/1/19/1369


27.1.2022




27.1.2022


Arsenic trioxide medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstraße 6, 22880 Wedel, Deutschland






EU/1/20/1475


31.1.2022




27.1.2022


Desloratadine ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/11/746


30.1.2022




27.1.2022


Gilenya







Novartis Europharm Limited




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






EU/1/11/677


28.1.2022




27.1.2022


Libmeldy







Orchard Therapeutics (Netherlands) B.V.




Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland






EU/1/20/1493


31.1.2022




27.1.2022


Lorviqua







Pfizer Europe MA EEIG




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






EU/1/19/1355


28.1.2022




27.1.2022


Pemetrexed Accord







Accord Healthcare S.L.U.




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






EU/1/15/1071


28.1.2022




27.1.2022


Staquis







Pfizer Europe MA EEIG




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






EU/1/19/1421


28.1.2022




27.1.2022


Telmisartan Teva Pharma







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/11/719


28.1.2022




27.1.2022


Zinforo







Pfizer Ireland Pharmaceuticals




Operations Support Group, Ringaskiddy, County Cork, Ireland






EU/1/12/785


28.1.2022




27.1.2022


Zonegran







Amdipharm Limited




3 Burlington Road, Dublin 4, D04 RD68, IRELAND






EU/1/04/307


28.1.2022




31.1.2022


Avastin







Roche Registration GmbH




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






EU/1/04/300


1.2.2022




31.1.2022


Benepali







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/15/1074


4.2.2022




31.1.2022


Besremi







AOP Orphan Pharmaceuticals GmbH,




Leopold-Ungar-Platz 2, 1190 Wien, Österreich






EU/1/18/1352


2.2.2022




31.1.2022


Entyvio







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbæk Strand, Danmark






EU/1/14/923


2.2.2022




31.1.2022


Ervebo







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/19/1392


2.2.2022




31.1.2022


Fareston







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/1/96/004


1.2.2022




31.1.2022


Juluca







ViiV Healthcare B.V.




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






EU/1/18/1282


1.2.2022




31.1.2022


Luveris







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/00/155


2.2.2022




31.1.2022


Mulpleo







Shionogi B.V.




Kingsfordweg 151, 1043 GR Amsterdam, Nederland






EU/1/18/1348


1.2.2022




31.1.2022


Pemetrexed Hospira







Pfizer Europe MA EEIG




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






EU/1/15/1057


1.2.2022




31.1.2022


Rhokiinsa







Santen Oy




Niittyhaankatu 20, 33720 Tampere, Suomi






EU/1/19/1400


2.2.2022




31.1.2022


Spinraza







Biogen Netherlands B.V.




Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland






EU/1/17/1188


1.2.2022




31.1.2022


Tivicay







ViiV Healthcare BV




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






EU/1/13/892


1.2.2022




—   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




31.1.2022


Staquis







Pfizer Europe MA EEIG




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






EU/1/19/1421


1.2.2022




—   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




11.1.2022


CircoMax


Porcine circovirus vaccine (inactivated, recombinant)







Zoetis Belgium S.A.




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






EU/2/21/281


Emulsion for injection


QI09AA07


12.1.2022




—   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




4.1.2022


Meloxidolor







Le Vet Beheer B.V.




Wilgenweg 7, 3421 TV Oudewater, Nederland






EU/2/13/148


11.1.2022




4.1.2022


Sileo







Orion Corporation




Orionintie 1, 02200 Espoo, Suomi






EU/2/15/181


5.1.2022




4.1.2022


VarroMed







BeeVital GmbH




Wiesenbergstrasse 19,A- 5164, Seeham, Österreich






EU/2/16/203


17.1.2022




11.1.2022


Innovax-ILT







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/15/182


13.1.2022




11.1.2022


Vectormune FP ILT + AE







Ceva-Phylaxia Co. Ltd.




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/20/250


17.1.2022




20.1.2022


Improvac







Zoetis Belgium S.A.




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






EU/2/09/095


21.1.2022




24.1.2022


Suvaxyn Aujeszky 783 + O/W







Zoetis Belgium S.A.




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






EU/2/98/009


25.1.2022




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.