Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2017 to 30 November 2017 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2017-12-29
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2017447EN.01000101.xml










29.12.2017   


EN


Official Journal of the European Union


C 447/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2017 to 30 November 2017
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2017/C 447/01)
—   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




10.11.2017


Cyltezo


adalimumab


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


EU/1/17/1240


Solution for injection


L04AB04


14.11.2017




10.11.2017


Miglustat Gen.Orph


Miglustat


Gen.Orph
100 rue Louis Blanc, TSA/Bâtiment Copenhague, 60160 Montataire, France


EU/1/17/1232


Capsule, hard


A16AX06


14.11.2017




10.11.2017


Nyxoid


naloxone


Mundipharma Corporation Limited
Cambridge Science Park, Milton Road, Cambridge CB4 0AB, United Kingdom


EU/1/17/1238


Nasal spray, solution


V03AB15


14.11.2017




10.11.2017


Ritonavir Mylan


ritonavir


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


EU/1/17/1242


Film-coated tablet


J05AE03


14.11.2017




10.11.2017


TOOKAD


padeliporfin


Steba Biotech S.A
7 Place du Théâtre, 2613 Luxembourg, Luxembourg


EU/1/17/1228


Powder for solution for injection


L01XD07


14.11.2017




10.11.2017


Tremfya


Guselkumab


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


EU/1/17/1234


Solution for injection


L04AC


14.11.2017




10.11.2017


VeraSeal


human fibrinogen / human thrombin


Instituto Grifols, S.A.
Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa


EU/1/17/1239


Solutions for sealant


B02BC


14.11.2017




10.11.2017


Zubsolv


buprenorphine / naloxone


Mundipharma Corporation Limited
Cambridge Science Park, Milton Road, Cambridge CB4 0AB, United Kingdom


EU/1/17/1233


Sublingual tablet


N07BC51


14.11.2017




15.11.2017


Elebrato Ellipta


fluticasone furoate/umeclidinium/vilanterol


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


EU/1/17/1237


Inhalation powder, pre-dispensed


Pending


17.11.2017




15.11.2017


Imatinib Teva B.V.


imatinib


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


EU/1/17/1243


Capsule, hard
Film-coated tablet


L01XE01


17.11.2017




15.11.2017


Ontruzant


trastuzumab


Samsung Bioepis UK Limited
5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom


EU/1/17/1241


Powder for concentrate for solution for infusion


L01XC03


17.11.2017




15.11.2017


Trelegy Ellipta


fluticasone furoate/umeclidinium/vilanterol


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


EU/1/17/1236


Inhalation powder, pre-dispensed


Pending


17.11.2017




16.11.2017


Zejula


niraparib


TESARO UK LIMITED
55 Baker Street, London W1U 7EU, United Kingdom


EU/1/17/1235


Capsule, hard


L01XX54


20.11.2017




—   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




16.11.2017


Adlumiz


Helsinn Birex Pharmaceuticals Ltd
Damastown, Mulhuddart, Dublin 15, Ireland


—


20.11.2017




—   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




10.11.2017


ADCETRIS


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


EU/1/12/794


14.11.2017




10.11.2017


APTIVUS


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


EU/1/05/315


14.11.2017




10.11.2017


Benlysta


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


EU/1/11/700


16.11.2017




10.11.2017


BYDUREON


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/11/696


14.11.2017




10.11.2017


ellaOne


Laboratoire HRA Pharma
15 rue Béranger, 75003 Paris, France


EU/1/09/522


14.11.2017




10.11.2017


Emtricitabine /Tenofovir disoproxil Krka d.d.


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


EU/1/17/1182


14.11.2017




10.11.2017


Exjade


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


EU/1/06/356


14.11.2017




10.11.2017


Exviera


AbbVie Ltd
Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom


EU/1/14/983


14.11.2017




10.11.2017


Faslodex


AstraZeneca UK Limited
Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom


EU/1/03/269


14.11.2017




10.11.2017


Glubrava


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


EU/1/07/421


14.11.2017




10.11.2017


Humira


AbbVie Ltd
Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom


EU/1/03/256


14.11.2017




10.11.2017


Iblias


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/15/1077


14.11.2017




10.11.2017


Kolbam


Retrophin Europe Limited
Palmerstown House, Fenian Street, Dublin 2, Ireland


EU/1/13/895


14.11.2017




10.11.2017


Kovaltry


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/15/1076


14.11.2017




10.11.2017


Mepact


Takeda France SAS
Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France


EU/1/08/502


14.11.2017




10.11.2017


NexoBrid


MediWound Germany GmbH
Eisenstraße 5, 65428 Ruesselsheim, Deutschland


EU/1/12/803


14.11.2017




10.11.2017


Ovitrelle


Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/00/165


15.11.2017




10.11.2017


Pegasys


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


EU/1/02/221


14.11.2017




10.11.2017


Plegridy


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


EU/1/14/934


14.11.2017




10.11.2017


Revatio


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


EU/1/05/318


14.11.2017




10.11.2017


Selincro


H. Lundbeck A/S
Ottiliavej 9, 2500 Valby, Danmark


EU/1/12/815


14.11.2017




10.11.2017


Tandemact


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


EU/1/06/366


14.11.2017




10.11.2017


Teysuno


Nordic Group B.V.
Siriusdreef 22, 2132 WT Hoofddorp, Nederland


EU/1/11/669


14.11.2017




10.11.2017


Valdoxan


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


EU/1/08/499


14.11.2017




15.11.2017


Aripiprazole Accord


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


EU/1/15/1045


17.11.2017




15.11.2017


Bortezomib SUN


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


EU/1/16/1102


17.11.2017




15.11.2017


Emtricitabine/Tenofovir disoproxil Krka


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


EU/1/16/1151


17.11.2017




15.11.2017


Imvanex


Bavarian Nordic A/S
Hejreskovvej 10a, 3490 Kvistgaard, Danmark


EU/1/13/855


17.11.2017




15.11.2017


Kyprolis


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


EU/1/15/1060


17.11.2017




15.11.2017


Lemtrada


Genzyme Therapeutics Ltd
4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom


EU/1/13/869


17.11.2017




15.11.2017


NovoEight


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


EU/1/13/888


17.11.2017




15.11.2017


Ozurdex


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


EU/1/10/638


20.11.2017




15.11.2017


ReFacto AF


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


EU/1/99/103


17.11.2017




15.11.2017


Savene


Clinigen Healthcare Limited
Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom


EU/1/06/350


17.11.2017




15.11.2017


Saxenda


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


EU/1/15/992


17.11.2017




15.11.2017


Tasigna


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


EU/1/07/422


17.11.2017




15.11.2017


Viekirax


AbbVie Ltd
Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom


EU/1/14/982


17.11.2017




15.11.2017


Voncento


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


EU/1/13/857


17.11.2017




15.11.2017


Zytiga


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


EU/1/11/714


17.11.2017




16.11.2017


ATryn


Laboratoire français du Fractionnement et des Biotechnologies
3 Avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France


EU/1/06/355


20.11.2017




16.11.2017


Cubicin


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


EU/1/05/328


20.11.2017




16.11.2017


Docetaxel Winthrop


Aventis Pharma S.A.
20 avenue Raymond Aron, 92165 Antony CEDEX, France


EU/1/07/384


20.11.2017




16.11.2017


Elocta


Swedish Orphan Biovitrum AB (publ)
112 76 Stockholm, Sverige


EU/1/15/1046


20.11.2017




16.11.2017


Helixate NexGen


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/00/144


20.11.2017




16.11.2017


KOGENATE Bayer


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/00/143


20.11.2017




16.11.2017


Levemir


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


EU/1/04/278


20.11.2017




16.11.2017


Levetiracetam Accord


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


EU/1/11/712


20.11.2017




16.11.2017


Taxotere


Aventis Pharma S.A.
20 avenue Raymond Aron, 92165 Antony CEDEX, France


EU/1/95/002


20.11.2017




16.11.2017


Zydelig


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/938


20.11.2017




24.11.2017


Advate


Baxter AG
Industriestraße 67, 1221 Wien, Österreich


EU/1/03/271


28.11.2017




24.11.2017


Nuwiq


Octapharma AB
Lars Forssells gata 23, 112 75 Stockholm, Sverige


EU/1/14/936


28.11.2017




28.11.2017


Entacapone Orion


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/1/11/708


30.11.2017




28.11.2017


Prepandrix


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


EU/1/08/453


30.11.2017




28.11.2017


Privigen


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


EU/1/08/446


30.11.2017




30.11.2017


Zepatier


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


EU/1/16/1119


4.12.2017




—   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




10.11.2017


Prevenar


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


EU/1/00/167


14.11.2017




15.11.2017


EVARREST


Omrix Biopharmaceuticals N.V.
Leonardo Da Vincilaan 15, 1831 Diegem, België


EU/1/13/868


17.11.2017




—   Suspension of a marketing authorisation (Article 20 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




23.11.2017


Optimark


Guerbet
15 rue des Vanesses, 93420, Villepinte, France


EU/1/07/398


27.12.2017




—   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




6.11.2017


Nobivac LeuFel


Feline leukaemia vaccine (inactivated)


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


EU/2/17/217


Suspension for injection


QI06AA01


8.11.2017




21.11.2017


Bovilis Blue-8


Bluetongue virus vaccine (inactivated) serotype 8


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


EU/2/17/218


Suspension for injection


QI02AA08
QI04AA02


23.11.2017




—   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




14.11.2017


SevoFlo


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


EU/2/02/035


16.11.2017




15.11.2017


Contacera


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


EU/2/12/144


16.11.2017




21.11.2017


Circovac


Ceva-Phylaxia Zrt.
Szállás u. 5, 1107 Budapest, Magyarország


EU/2/07/075


23.11.2017




21.11.2017


Pexion


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


EU/2/12/147


23.11.2017




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.