Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2019 to 30 September 2019 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2019-10-30
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2019369EN.01000101.xml










30.10.2019   


EN


Official Journal of the European Union


C 369/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2019 to 30 September 2019

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
 (1)

)

(2019/C 369/01)






—



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




19.9.2019


Epidyolex


cannabidiol


GW Pharma (International) B.V.
Amersfoort A1, Databankweg 26, 3821AL Amersfoort, Nederland


EU/1/19/1389


Oral solution


N03AX24


23.9.2019




19.9.2019


Inbrija


levodopa


Acorda Therapeutics Ireland Limited
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland


EU/1/19/1390


Inhalation powder, hard capsule


N04BA01


23.9.2019




19.9.2019


VITRAKVI


larotrectinib


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/19/1385


Capsule, hard
Oral solution


L01XE53


23.9.2019




26.9.2019


Deferasirox Mylan


deferasirox


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


EU/1/19/1386


Film-coated tablet


V03AC03


30.9.2019




26.9.2019


Trogarzo


ibalizumab


Theratechnologies International Limited
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland


EU/1/19/1359


Concentrate for solution for infusion


J05AX23


30.9.2019




27.9.2019


NUCEIVA


botulinum toxin type A


Evolus Pharma Limited
70 Sir John Rogerson's Quay, Dublin 2, Ireland


EU/1/19/1364


Powder for solution for injection


M03AX01


1.10.2019










—



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




3.9.2019


AMGLIDIA


AMMTeK
55 rue de Turbigo, 75003 Paris, France


EU/1/18/1279


5.9.2019




3.9.2019


Clopidogrel Zentiva


Zentiva, k.s.
U Kabelovny 130, 10 237 Praha 10, Česká republika


EU/1/08/465


5.9.2019




3.9.2019


Cosentyx


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


EU/1/14/980


5.9.2019




3.9.2019


DuoPlavin


Sanofi Clir SNC
54 rue La Boétie, 75008 Paris, France


EU/1/10/619


5.9.2019




3.9.2019


Emtricitabine/Tenofovir disoproxil Zentiva


Zentiva, k.s.
U Kabelovny 130, 10 237 Praha 10, Česká republika


EU/1/16/1148


5.9.2019




3.9.2019


GILENYA


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


EU/1/11/677


5.9.2019




3.9.2019


Lonsurf


Les Laboratoires Servier
50 rue Carnot, 92284 Suresnes CEDEX, France


EU/1/16/1096


5.9.2019




3.9.2019


Lucentis


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


EU/1/06/374


5.9.2019




3.9.2019


Pramipexole Teva


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


EU/1/08/490


5.9.2019




3.9.2019


Stelara


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/08/494


5.9.2019




3.9.2019


Suliqua


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


EU/1/16/1157


5.9.2019




3.9.2019


Sylvant


EUSA Pharma (Netherlands) B.V.
Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland


EU/1/14/928


5.9.2019




3.9.2019


Tecentriq


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/17/1220


5.9.2019




6.9.2019


IMBRUVICA


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/14/945


10.9.2019




6.9.2019


Pylobactell


Torbet Laboratories Ireland Limited
20 Holles Street, Dublin 2, Ireland


EU/1/98/064


10.9.2019




6.9.2019


Rasagiline ratiopharm


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


EU/1/14/977


10.9.2019




9.9.2019


Fexeric


Akebia Europe Limited c/o Matheson, 70 Sir John Rogerson’s Quay, Dublin 2, Ireland


EU/1/15/1039


11.9.2019




9.9.2019


Kovaltry


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/15/1076


11.9.2019




13.9.2019


Atripla


Bristol-Myers Squibb and Gilead Sciences Limited
IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland


EU/1/07/430


17.9.2019




13.9.2019


Kyntheum


Leo Pharma A/S
Industriparken 55, 2750 Ballerup, Danmark


EU/1/16/1155


17.9.2019




13.9.2019


Levetiracetam Actavis Group


Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland


EU/1/11/738


17.9.2019




13.9.2019


Opatanol


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


EU/1/02/217


17.9.2019




13.9.2019


Prepandrix


GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique


EU/1/08/453


17.9.2019




13.9.2019


Rapamune


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


EU/1/01/171


17.9.2019




13.9.2019


Sivextro


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


EU/1/15/991


17.9.2019




13.9.2019


Twinrix Adult


GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique


EU/1/96/020


17.9.2019




13.9.2019


Twinrix Paediatric


GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique


EU/1/97/029


17.9.2019




16.9.2019


Champix


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


EU/1/06/360


18.9.2019




16.9.2019


Cosentyx


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


EU/1/14/980


18.9.2019




16.9.2019


Elonva


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


EU/1/09/609


18.9.2019




16.9.2019


Fertavid


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


EU/1/09/510


18.9.2019




16.9.2019


Inflectra


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


EU/1/13/854


18.9.2019




16.9.2019


Laventair Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/899


18.9.2019




16.9.2019


Lymphoseek


Norgine B.V.
Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland


EU/1/14/955


18.9.2019




16.9.2019


Mepsevii


Ultragenyx Germany GmbH
Friedrichstraße 191, 10117 Berlin, Deutschland


EU/1/18/1301


18.9.2019




16.9.2019


Ninlaro


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


EU/1/16/1094


18.9.2019




16.9.2019


Nivestim


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


EU/1/10/631


18.9.2019




16.9.2019


Olumiant


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


EU/1/16/1170


18.9.2019




16.9.2019


Pregabalin Zentiva


Zentiva, k.s.
U Kabelovny 130, 10 237 Praha 10, Česká republika


EU/1/15/1021


18.9.2019




16.9.2019


Remsima


Celltrion Healthcare Hungary Kft.
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország


EU/1/13/853


18.9.2019




16.9.2019


Riximyo


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/17/1184


18.9.2019




16.9.2019


Somavert


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


EU/1/02/240


18.9.2019




16.9.2019


Stelara


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/08/494


18.9.2019




16.9.2019


Tenofovir disoproxil Zentiva


Zentiva, k.s.
U Kabelovny 130, 10 237 Praha 10, Česká republika


EU/1/16/1127


18.9.2019




19.9.2019


ADCETRIS


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


EU/1/12/794


23.9.2019




19.9.2019


Anoro Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/898


23.9.2019




19.9.2019


Ganfort


Allergan Pharmaceuticals Ireland
Castlebar Road, Westport, County Mayo, Ireland


EU/1/06/340


23.9.2019




19.9.2019


Lumark


IDB Holland B.V.
Weverstraat 17, 5111 PV Baarle-Nassau, Nederland


EU/1/15/1013


23.9.2019




19.9.2019


Lysodren


HRA Pharma Rare Diseases
200 avenue de Paris, 92 320 Chatillon, France


EU/1/04/273


23.9.2019




19.9.2019


Multaq


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


EU/1/09/591


23.9.2019




19.9.2019


Tegsedi


Akcea Therapeutics Ireland Ltd
Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland


EU/1/18/1296


23.9.2019




19.9.2019


Tyverb


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


EU/1/07/440


23.9.2019




19.9.2019


Viekirax


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/14/982


23.9.2019




19.9.2019


Xadago


Zambon S.p.A.
Via Lillo del Duca 10, 20 091 Bresso (MI), Italia


EU/1/14/984


23.9.2019




23.9.2019


APTIVUS


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/05/315


25.9.2019




23.9.2019


BYDUREON


AstraZeneca AB
15 185 Södertälje, Sverige


EU/1/11/696


25.9.2019




23.9.2019


Caelyx


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/96/011


25.10.2019




23.9.2019


Ciambra


Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg


EU/1/15/1055


25.9.2019




23.9.2019


EndolucinBeta


ITG Isotope Technologies Garching GmbH
Lichtenbergstraße 1, 85748 Garching, Deutschland


EU/1/16/1105


25.9.2019




23.9.2019


Epclusa


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


EU/1/16/1116


25.9.2019




23.9.2019


Hyrimoz


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/18/1286


25.9.2019




23.9.2019


Incruse Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/922


25.9.2019




23.9.2019


Moventig


Kyowa Kirin Holdings B.V.
Bloemlaan 2, 2132 NP Hoofddorp, Nederland


EU/1/14/962


25.9.2019




23.9.2019


Myalepta


Aegerion Pharmaceuticals B.V.
Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland


EU/1/18/1276


25.9.2019




23.9.2019


Ofev


Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/14/979


25.9.2019




23.9.2019


Parsabiv


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


EU/1/16/1142


25.9.2019




23.9.2019


Rixathon


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/17/1185


25.9.2019




23.9.2019


Saxenda


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


EU/1/15/992


25.9.2019




23.9.2019


Thyrogen


Genzyme Europe B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland


EU/1/99/122


25.9.2019




23.9.2019


Tolura


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


EU/1/10/632


25.9.2019




23.9.2019


Vectibix


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


EU/1/07/423


25.9.2019




26.9.2019


Cyramza


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


EU/1/14/957


30.9.2019




26.9.2019


Exviera


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/14/983


30.9.2019




26.9.2019


OPDIVO


Bristol-Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland


EU/1/15/1014


30.9.2019




26.9.2019


Rolufta Ellipta


GlaxoSmithKline Trading Services Limited
Currabinny, Carrigaline, County Cork, Ireland


EU/1/17/1174


30.9.2019




26.9.2019


Vosevi


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


EU/1/17/1223


30.9.2019










—



Withdrawal of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




3.9.2019


Iblias


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/15/1077


5.9.2019










—



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




17.9.2019


Simparica Trio


sarolaner / moxidectin / pyrantel embonate


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


EU/2/19/243


Chewable tablet


QP54AB52


19.9.2019










—



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




6.9.2019


RESPIPORC FLUpan H1N1


IDT Biologika GmbH
Am Pharmapark, 06861 Dessau-Rosslau, Deutschland


EU/2/17/209


10.9.2019




13.9.2019


Porcilis PCV M Hyo


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


EU/2/14/175


17.9.2019




20.9.2019


Cepedex


CP-Pharma Handelsgesellschaft mbH
Ostlandring 13, 31303 Burgdorf, Deutschland


EU/2/16/200


24.9.2019




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




The Netherlands






(1)  OJ L 136, 30.4.2004, p. 1.