Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2020 to 31 May 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2020-06-26
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_2020213EN.01000301.xml










26.6.2020   


EN


Official Journal of the European Union


C 213/3






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2020 to 31 May 2020
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2020/C 213/02)
—   Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




18.5.2020


Zolgensma


onasemnogene abeparvovec


AveXis EU Limited
Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland


EU/1/20/1443


Solution for infusion


M09AX09


18.5.2020




20.5.2020


Fluad Tetra


influenza vaccine (surface antigen, inactivated, adjuvanted)


Seqirus Netherlands B.V.
Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands


EU/1/20/1433


Suspension for injection in pre-filled syringe (injection).


J07BB02


26.5.2020




20.5.2020


Nepexto


etanercept


Mylan IRE Healthcare Limited
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Ireland


EU/1/20/1436


Solution for injection


L04AB01


29.5.2020




30.5.2020


Atectura Breezhaler


indacaterol/mometasone furoate


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/20/1439


Inhalation powder, hard capsule


R03AK14


2.6.2020




30.5.2020


Bemrist Breezhaler


indacaterol/mometasone furoate


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/20/1441


Inhalation powder, hard capsule


R03AK


2.6.2020




30.5.2020


Sarclisa


isatuximab


Sanofi-Aventis groupe
54 rue La Boétie, 75008 Paris, France


EU/1/20/1435


Concentrate for solution for infusion


L01XC38


3.6.2020




—   Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




4.5.2020


Axura


Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland


EU/1/02/218


8.5.2020




4.5.2020


Bortezomib Accord


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/15/1019


12.5.2020




4.5.2020


Bronchitol


Pharmaxis Europe Limited
108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland


EU/1/12/760


5.5.2020




4.5.2020


Clopidogrel Apotex


Apotex Europe B.V.
Archimedesweg 2, 2333 CN Leiden, Nederland


EU/1/09/568


6.5.2020




4.5.2020


Clopidogrel Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/09/559


5.5.2020




4.5.2020


Clopidogrel Teva


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/09/540


7.5.2020




4.5.2020


Cystadrops


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


EU/1/15/1049


6.5.2020




4.5.2020


Ferriprox


Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/99/108


7.5.2020




4.5.2020


Grepid


Pharmathen S.A.
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα


EU/1/09/535


5.5.2020




4.5.2020


Ilumetri


Almirall, S.A.
Ronda General Mitre, 151, 08022 Barcelona, España


EU/1/18/1323


5.5.2020




4.5.2020


Pemetrexed Krka


KRKA, d.d.
Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/18/1283


12.5.2020




4.5.2020


Pemetrexed medac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6, 22880 Wedel, Deutschland


EU/1/15/1038


12.5.2020




4.5.2020


Raxone


Santhera Pharmaceuticals (Deutschland) GmbH
Marie-Curie Straße 8, 79539 Lörrach, Deutschland


EU/1/15/1020


14.5.2020




4.5.2020


Tafinlar


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/13/865


8.5.2020




4.5.2020


Wilzin


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


EU/1/04/286


5.5.2020




4.5.2020


Xultophy


Novo Nordisk A/S
Novo Allé, 2880 Bagsvaerd, Danmark


EU/1/14/947


6.5.2020




5.5.2020


Naglazyme


BioMarin International Limited
Shanbally, Ringaskiddy, County Cork P43 R298, Ireland


EU/1/05/324


6.5.2020




12.5.2020


ADCETRIS


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/12/794


19.5.2020




12.5.2020


Clopidogrel Krka


KRKA d d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/09/556


13.5.2020




12.5.2020


Movymia


STADA Arzneimittel AG
Stadastraße 2-18, 61118 Bad Vilbel, Deutschland


EU/1/16/1161


13.5.2020




12.5.2020


Pemetrexed Hospira


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/15/1057


14.5.2020




12.5.2020


Segluromet


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/18/1265


14.5.2020




12.5.2020


Steglatro


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/18/1267


14.5.2020




12.5.2020


Steglujan


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/18/1266


14.5.2020




12.5.2020


Vedrop


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


EU/1/09/533


13.5.2020




14.5.2020


Clopidogrel Krka d.d.


KRKA d d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/09/562


18.5.2020




14.5.2020


Firdapse


SERB S.A.
Avenue Louise 480, 1050 Bruxelles, Belgique/Louizalaan 480, 1050 Brussel, België


EU/1/09/601


15.5.2020




14.5.2020


Yellox


Bausch Health Ireland Limited
3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland


EU/1/11/692


15.5.2020




18.5.2020


Signifor


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


EU/1/12/753


19.5.2020




20.5.2020


Daxas


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/10/636


28.5.2020




20.5.2020


Ivabradine Anpharm


ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
ul. Annopol 6B, 03–236 Warszawa, Polska


EU/1/15/1041


25.5.2020




20.5.2020


Jorveza


Dr Falk Pharma GmbH
Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland


EU/1/17/1254


26.5.2020




20.5.2020


Lenvima


Eisai GmbH
Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland


EU/1/15/1002


26.5.2020




20.5.2020


LIBTAYO


Regeneron Ireland Designated Activity Company (DAC)
Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland


EU/1/19/1376


26.5.2020




20.5.2020


Nplate


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/08/497


25.5.2020




20.5.2020


Odomzo


Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, 2132 JH Hoofddorp, Nederland


EU/1/15/1030


28.5.2020




20.5.2020


Onpattro


Alnylam Netherlands B.V.
Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland


EU/1/18/1320


25.5.2020




20.5.2020


Pregabalin Zentiva


Zentiva, k.s.
U Kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/15/1021


25.5.2020




20.5.2020


Revestive


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


EU/1/12/787


11.6.2020




20.5.2020


Tybost


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/13/872


25.5.2020




—   Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




20.5.2020


Emgality


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/18/1330


27.5.2020










—



Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




18.5.2020


Lydaxx


tulathromycin


VETOQUINOL S.A.
Magny-Vernois, 70200 Lure, France


EU/2/20/253


Solution for injection


QJ01FA94


19.5.2020




—   Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




4.5.2020


Apoquel


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/13/154


7.5.2020




4.5.2020


Loxicom


Norbrook Laboratories (Ireland) Limited
Rossmore Industrial Estate, Monaghan, Ireland


EU/2/08/090


7.5.2020




12.5.2020


Equilis Prequenza Te


Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland


EU/2/05/057


15.5.2020




18.5.2020


Equilis Prequenza


Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland


EU/2/05/056


20.5.2020




18.5.2020


Equilis Te


Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland


EU/2/05/055


20.5.2020




27.5.2020


CYTOPOINT


Zoetis Belgium S.A.
rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/17/205


27.5.2020




27.5.2020


Porcilis PCV ID


Intervet International B.V.
Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland


EU/2/15/187


2.6.2020




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.