Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 2019(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2019-06-28
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2019218EN.01000101.xml










28.6.2019   


EN


Official Journal of the European Union


C 218/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 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 218/01)






—



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




3.5.2019


Palynziq


pegvaliase


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


EU/1/19/1362


Solution for injection


A16AB19


8.5.2019




3.5.2019


Waylivra


volanesorsen


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


EU/1/19/1360


Solution for injection


Pending


8.5.2019




6.5.2019


Lorviqua


lorlatinib


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


EU/1/19/1355


Film-coated tablet


L01XE44


8.5.2019




6.5.2019


Pazenir


paclitaxel


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


EU/1/18/1317


Powder for dispersion for infusion


L01CD01


8.5.2019




29.5.2019


Zynteglo


autologous CD34+ cells encoding βΑ-T87Q-globin gene


bluebird bio (Netherlands) B.V.
Stadsplateau 7, 3521 AZ Utrecht, Nederland


EU/1/19/1367


Dispersion for infusion


Pending


4.6.2019










—



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




3.5.2019


Clopidogrel Krka d.d.


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


EU/1/09/562


8.5.2019




3.5.2019


Episalvan


Amryt AG
Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland


EU/1/15/1069


8.5.2019




3.5.2019


PREZISTA


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


EU/1/06/380


8.5.2019




3.5.2019


Ryzodeg


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


EU/1/12/806


8.5.2019




3.5.2019


Symtuza


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


EU/1/17/1225


8.5.2019




3.5.2019


Yondelis


Pharma Mar S.A.
Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España


EU/1/07/417


8.5.2019




6.5.2019


Dupixent


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


EU/1/17/1229


9.5.2019




6.5.2019


Rezolsta


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


EU/1/14/967


8.5.2019




6.5.2019


Ritonavir Mylan


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


EU/1/17/1242


9.5.2019




6.5.2019


Twynsta


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


EU/1/10/648


8.5.2019




13.5.2019


Ferriprox


Apotex B.V.
Keizersgracht 311, 1016 EE, Amsterdam, Nederland


EU/1/99/108


15.5.2019




13.5.2019


Imnovid


Celgene Europe B.V.
Winthontlaan 6 N, 3526 KV Utrecht, Nederland


EU/1/13/850


15.5.2019




13.5.2019


Mozobil


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


EU/1/09/537


15.5.2019




13.5.2019


Ozempic


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


EU/1/17/1251


15.5.2019




13.5.2019


Pradaxa


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


EU/1/08/442


15.5.2019




13.5.2019


Ratiograstim


ratiopharm GmbH
Graf-Arco-Straße 3, 89079 Ulm, Deutschland


EU/1/08/444


15.5.2019




13.5.2019


Revlimid


Celgene Europe B.V.
Winthontlaan 6 N, 3526 KV Utrecht, Nederland


EU/1/07/391


15.5.2019




13.5.2019


Tevagrastim


Teva GmbH
Graf-Arco-Straße 3, 89079 Ulm, Deutschland


EU/1/08/445


15.5.2019




16.5.2019


Pemetrexed medac


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


EU/1/15/1038


20.5.2019




16.5.2019


Xeplion


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


EU/1/11/672


20.5.2019




20.5.2019


Bondronat


Atnahs Pharma Netherlands B.V.
Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland


EU/1/96/012


22.5.2019




20.5.2019


Epclusa


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


EU/1/16/1116


22.5.2019




20.5.2019


Kuvan


BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, Ireland


EU/1/08/481


22.5.2019




20.5.2019


TachoSil


Takeda Austria GmbH
St.-Peter-Strasse 25, 4020 Linz, Österreich


EU/1/04/277


22.5.2019




22.5.2019


Adenuric


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


EU/1/08/447


27.5.2019




22.5.2019


Blitzima


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


EU/1/17/1205


27.5.2019




22.5.2019


Bonviva


Atnahs Pharma Netherlands B.V.
Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland


EU/1/03/265


28.5.2019




22.5.2019


Competact


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


EU/1/06/354


27.5.2019




22.5.2019


Erbitux


Merck Europe B.V.
Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland


EU/1/04/281


27.5.2019




22.5.2019


KEYTRUDA


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


EU/1/15/1024


27.5.2019




22.5.2019


Tyverb


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


EU/1/07/440


27.5.2019




27.5.2019


Opdivo


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


EU/1/15/1014


29.5.2019




27.5.2019


Tafinlar


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


EU/1/13/865


29.5.2019




27.5.2019


Tandemact


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


EU/1/06/366


29.5.2019




27.5.2019


Trisenox


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


EU/1/02/204


29.5.2019




27.5.2019


Xeloda


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


EU/1/00/163


29.5.2019




27.5.2019


Xermelo


Ipsen Pharma
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France


EU/1/17/1224


29.5.2019










—



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




13.5.2019


Nonafact


Sanquin Plasma Products B.V.
Plesmanlaan 125, 1066 CX Amsterdam, Nederland


EU/1/01/186


15.5.2019










—



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




20.5.2019


Afoxolaner MERIAL


afoxolaner


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/19/240


Chewable tablet


QP53BE01


22.5.2019




20.5.2019


Baycox Iron


toltrazuril/gleptoferron


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/19/239


Suspension for injection


QP51AJ51


22.5.2019










—



Issuing of a marketing authorisation (Article 38 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




13.5.2019


Horse Allo 20


Centauri Biotech SL
Calle Asunción SN - 1oIzq (Meicende — Arteixo), 15142 A Coruña, España


—


15.5.2019










—



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




13.5.2019


Cortavance


VIRBAC S.A.
1ère Avenue - 2065 m — L.I.D., 06516 Carros Cedex, France


EU/2/06/069


15.5.2019




27.5.2019


Innovax-ND-IBD


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


EU/2/17/213


29.5.2019




27.5.2019


VEPURED


Laboratorios Hipra, S.A.
Avda. La Selva, 135, 17170 Amer (Girona), España


EU/2/17/214


29.5.2019




29.5.2019


Suvaxyn PCV


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


EU/2/09/099


4.6.2019




29.5.2019


Versican Plus Pi/L4R


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


EU/2/14/173


4.6.2019




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.