Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2018 to 31 January 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2018-02-23
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2018070EN.01000101.xml










23.2.2018   


EN


Official Journal of the European Union


C 70/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2018 to 31 January 2018
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2018/C 070/01)






—



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




8.1.2018


ADYNOVI


rurioctocog alfa pegol


Baxalta Innovations GmbH
Industriestraße 67, 1221 Wien, Österreich


EU/1/17/1247


Powder and solvent for solution for injection


B02BD02


10.1.2018




8.1.2018


Fasenra


benralizumab


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/17/1252


Solution for injection


R03DX10


10.1.2018




8.1.2018


Fulvestrant Mylan


fulvestrant


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


EU/1/17/1253


Solution for injection


L02BA03


10.1.2018




8.1.2018


Intrarosa


prasterone


Endoceutics Ltd.
Salisbury house, London Wall, London, EC2M 5PS, United Kingdom


EU/1/17/1255


Pessary


QM01AX92


6.2.2018




8.1.2018


Jorveza


budesonide


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


EU/1/17/1254


Orodispersible tablet


A07EA06


10.1.2018




8.1.2018


Ocrevus


ocrelizumab


Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/17/1231


Concentrate for solution for infusion


L04AA36


10.1.2018




8.1.2018


PREVYMIS


letermovir


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/17/1245


Concentrate for solution for infusion
Film-coated tablet


J05AX18


10.1.2018




15.1.2018


Mvasi


bevacizumab


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


EU/1/17/1246


Concentrate for solution for infusion


L01XC07


17.1.2018




18.1.2018


Darunavir Krka d.d.


darunavir


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


EU/1/17/1248


Film-coated tablet


J05AE10


22.1.2018




26.1.2018


Darunavir Krka


darunavir


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


EU/1/17/1249


Film-coated tablet


J05AE10


30.1.2018










—



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




8.1.2018


Onzeald


Nektar Therapeutics UK Limited
Elizabeth House, 13-19 Queen Street, Leeds LS1 2TW, United Kingdom


—


10.1.2018




15.1.2018


Fanaptum


Vanda Pharmaceuticals Limited
222 Regent Street, London W1B 5TR, United Kingdom


—


19.1.2018










—



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




8.1.2018


Bronchitol


Pharmaxis Pharmaceuticals Limited
25 Moorgate, London, EC2R 6AY, United Kingdom


EU/1/12/760


10.1.2018




8.1.2018


Cimzia


UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België


EU/1/09/544


10.1.2018




8.1.2018


Cometriq


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


EU/1/13/890


10.1.2018




8.1.2018


Comtess


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/1/98/082


10.1.2018




8.1.2018


Hexacima


Sanofi Pasteur SA
2 avenue Pont Pasteur, 69007 Lyon, France


EU/1/13/828


10.1.2018




8.1.2018


Hexyon


Sanofi Pasteur Europe
2 avenue Pont Pasteur, 69007 Lyon, France


EU/1/13/829


10.1.2018




8.1.2018


HyQvia


Baxalta Innovations GmbH
Industriestraße 67, 1221 Wien, Österreich


EU/1/13/840


10.1.2018




8.1.2018


Imatinib Actavis


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


EU/1/13/825


10.1.2018




8.1.2018


Ixiaro


Valneva Austria GmbH
Campus Vienna Biocenter 3, 1030 Wien, Österreich


EU/1/08/501


10.1.2018




8.1.2018


Jardiance


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


EU/1/14/930


10.1.2018




8.1.2018


Memantine LEK


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


EU/1/13/826


10.1.2018




8.1.2018


Memantine Mylan


Generics [UK] Limited
Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom


EU/1/13/827


15.1.2018




8.1.2018


Nemdatine


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


EU/1/13/824


10.1.2018




8.1.2018


Orkambi


Vertex Pharmaceuticals (Europe) Limited
2 Kingdom Street, London W2 6BD, United Kingdom


EU/1/15/1059


10.1.2018




8.1.2018


Pradaxa


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


EU/1/08/442


10.1.2018




8.1.2018


Stayveer


Marklas Nederland B.V.
Beneluxlaan 2b, 3446 GR Woerden, Nederland


EU/1/13/832


10.1.2018




8.1.2018


Synjardy


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


EU/1/15/1003


10.1.2018




8.1.2018


Tolucombi


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


EU/1/13/821


10.1.2018




8.1.2018


Votrient


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/10/628


10.1.2018




8.1.2018


Yervoy


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/11/698


10.1.2018




8.1.2018


Zinbryta


Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom


EU/1/16/1107


10.1.2018




8.1.2018


Zonegran


Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom


EU/1/04/307


10.1.2018




11.1.2018


Carbaglu


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France


EU/1/02/246


15.1.2018




11.1.2018


Cinacalcet Mylan


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


EU/1/15/1054


15.1.2018




11.1.2018


Cystadrops


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France


EU/1/15/1049


15.1.2018




11.1.2018


Cystagon


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France


EU/1/97/039


15.1.2018




11.1.2018


Lartruvo


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


EU/1/16/1143


15.1.2018




11.1.2018


Laventair


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/14/899


15.1.2018




11.1.2018


Levetiracetam Teva


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


EU/1/11/701


15.1.2018




11.1.2018


OLYSIO


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


EU/1/14/924


15.1.2018




15.1.2018


Adasuve


Ferrer Internacional S.A.
Gran Via Carlos III, 94 08028 Barcelona, España


EU/1/13/823


17.1.2018




15.1.2018


Ciambra


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


EU/1/15/1055


17.1.2018




15.1.2018


Prialt


Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom


EU/1/04/302


17.1.2018




15.1.2018


Zostavax


MSD VACCINS
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/06/341


17.1.2018




18.1.2018


Bortezomib Hospira


Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom


EU/1/16/1114


22.1.2018




18.1.2018


Leganto


UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België


EU/1/11/695


22.1.2018




18.1.2018


Marixino


Consilient Health Ltd
5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland


EU/1/13/820


22.1.2018




18.1.2018


Omidria


Omeros London Limited
Berkeley Square, London, W1J 6BD, United Kingdom


EU/1/15/1018


22.1.2018




18.1.2018


Taltz


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


EU/1/15/1085


22.1.2018




18.1.2018


Tenofovir disoproxil Zentiva


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


EU/1/16/1127


22.1.2018




18.1.2018


XALKORI


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/12/793


22.1.2018




18.1.2018


Yervoy


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/11/698


22.1.2018




24.1.2018


Cervarix


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


EU/1/07/419


26.1.2018




24.1.2018


DUAVIVE


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/14/960


26.1.2018




24.1.2018


IBRANCE


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/16/1147


26.1.2018




24.1.2018


LeukoScan


Immunomedics GmbH
Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland


EU/1/97/032


26.1.2018




25.1.2018


Matever


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


EU/1/11/711


29.1.2018




26.1.2018


Cerdelga


Genzyme Europe B.V.
Gooimeer 10, 1411 DD Naarden, Nederland


EU/1/14/974


30.1.2018




26.1.2018


Mysimba


Orexigen Therapeutics Ireland Limited
2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland


EU/1/14/988


30.1.2018




30.1.2018


Cialis


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


EU/1/02/237


31.1.2018




30.1.2018


Colobreathe


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


EU/1/11/747


1.2.2018




30.1.2018


Copalia


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/06/372


1.2.2018




30.1.2018


Copalia HCT


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/09/575


1.2.2018




30.1.2018


Cresemba


Basilea Medical Ltd
c/o Cox Costello & Horne Limited, Langwood House, 63-81 High Street, Rickmansworth, Hertfordshire WD3 1EQ, United Kingdom


EU/1/15/1036


1.2.2018




30.1.2018


Dafiro


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/06/371


1.2.2018




30.1.2018


Dafiro HCT


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/09/574


1.2.2018




30.1.2018


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan


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


EU/1/17/1222


1.2.2018




30.1.2018


Effentora


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


EU/1/08/441


1.2.2018




30.1.2018


Exforge HCT


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/09/569


1.2.2018




30.1.2018


Fycompa


Eisai Europe Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom


EU/1/12/776


1.2.2018




30.1.2018


Granpidam


Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom


EU/1/16/1137


1.2.2018




30.1.2018


Hizentra


CSL Behring GmbH
Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland


EU/1/11/687


1.2.2018




30.1.2018


Ivemend


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/07/437


1.2.2018




30.1.2018


Nplate


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


EU/1/08/497


1.2.2018




30.1.2018


Rotarix


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


EU/1/05/330


1.2.2018




30.1.2018


Stelara


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


EU/1/08/494


2.2.2018




30.1.2018


Vectibix


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


EU/1/07/423


1.2.2018










—



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




11.1.2018


Daliresp


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/11/668


15.1.2018




11.1.2018


Insulin Human Winthrop


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/06/368


15.1.2018




11.1.2018


Libertek


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/11/666


15.1.2018




18.1.2018


Zoledronic acid Teva Pharma


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


EU/1/12/772


22.1.2018




30.1.2018


LeukoScan


Immunomedics GmbH
Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland


EU/1/97/032


1.2.2018










—



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




9.1.2018


GALLIPRANT


grapiprant


Aratana Therapeutics NV
Ambachtenlaan 1, 3001 Heverlee, België


EU/2/17/221


Tablet


QM01AX92


11.1.2018




31.1.2018


MiPet Easecto


sarolaner


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


EU/2/17/220


Chewable tablet


QP53BE03


2.2.2018










—



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




9.1.2018


Cortavance


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


EU/2/06/069


11.1.2018




9.1.2018


Ypozane


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


EU/2/06/068


11.1.2018




12.1.2018


Aftovaxpur Doe


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/13/153


16.1.2018




12.1.2018


Leucofeligen FeLV/RCP


Virbac
1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France


EU/2/09/097


16.1.2018




12.1.2018


Virbagen Omega


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


EU/2/01/030


16.1.2018




12.1.2018


Zactran


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/08/082


16.1.2018




16.1.2018


Semintra


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/12/146


18.1.2018




31.1.2018


Meloxoral


Le Vet B.V.
Wilgenweg 7, 3421 TV Oudewater, Nederland


EU/2/10/111


2.2.2018




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




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.