Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2015 to 31 March 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2015-05-05
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015148EN.01000401.xml










5.5.2015   


EN


Official Journal of the European Union


C 148/4





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2015 to 31 March 2015
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2015/C 148/02)
—   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




18.3.2015


Vantobra


Tobramycin


PARI Pharma GmbH
Moosstrasse 3, D-82319 Starnberg, Deutschland


EU/1/14/932


Nebuliser solution


J01GB01


20.3.2015




19.3.2015


Ikervis


Ciclosporin


SANTEN S.A.S.
Bâtiment Genavenir IV, 1 rue Pierre Fontaine, F-91058 Evry Cedex, France


EU/1/15/990


Eye drops, emulsion


S01XA18


23.3.2015




19.3.2015


Orbactiv


oritavancin


The Medicines Company UK Ltd
115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom


EU/1/15/989


Powder for concentrate for solution for infusion


J01XA05


23.3.2015




19.3.2015


Raplixa


human fibrinogen/human thrombin


ProFibrix BV
Darwinweg 24, 2333 CR Leiden Nederland


EU/1/14/985


Sealant powder


B02BC30


23.3.2015




23.3.2015


Kengrexal


cangrelor


The Medicines Company UK Ltd
115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom


EU/1/15/994


Powder for concentrate for solution for infusion


B01AC25


25.3.2015




23.3.2015


Saxenda


liraglutide


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


EU/1/15/992


Solution for injection


A10BX07


25.3.2015




23.3.2015


Sivextro


tedizolid phosphate


Cubist (UK) Ltd
Unit 1 Horizon Business Village No 1, Brooklands Road, Weybridge, Surrey KT13 0RU United Kingdom


EU/1/15/991


Film-coated tablet
Powder for concentrate for solution for infusion


Pending


25.3.2015




26.3.2015


DUTREBIS


lamivudine/raltegravir


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


EU/1/15/995


Film-coated tablet


J05AR16


30.3.2015




26.3.2015


Mysimba


naltrexone/bupropion


Orexigen Therapeutics Ireland Limited
70 Sir John Rogerson's Quay, Dublin 2, Ireland


EU/1/14/988


Tablet


A08AA62


30.3.2015




26.3.2015


Quinsair


levofloxacin


Aptalis Pharma SAS
Route de Bû, F-78550 Houdan, France


EU/1/14/973


Nebuliser solution


J01MA12


30.3.2015




—   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




5.3.2015


Bretaris Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/781


9.3.2015




5.3.2015


Buccolam


ViroPharma SPRL-BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België


EU/1/11/709


6.3.2015




5.3.2015


Effentora


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


EU/1/08/441


9.3.2015




5.3.2015


Eklira Genuair


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/778


9.3.2015




5.3.2015


Instanyl


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


EU/1/09/531


9.3.2015




5.3.2015


Invirase


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


EU/1/96/026


9.3.2015




5.3.2015


Norvir


AbbVie Ltd
Maidenhead, SL6 4XE, United Kingdom


EU/1/96/016


9.3.2015




10.3.2015


Cholib


Abbott Healthcare Products Ltd
Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom


EU/1/13/866


12.3.2015




10.3.2015


Eurartesim


Sigma-Tau Industrie Farmaceutiche Riunite S.p.A
Viale Shakespeare 47, 00144 Roma, Italia


EU/1/11/716


12.3.2015




10.3.2015


Sildenafil Teva


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


EU/1/09/584


12.3.2015




10.3.2015


Truvada


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/04/305


12.3.2015




11.3.2015


Busulfan Fresenius Kabi


Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom


EU/1/14/951


13.3.2015




11.3.2015


Colobreathe


Forest Laboratories UK Ltd
Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent DA2 6SL, United Kingdom


EU/1/11/747


13.3.2015




11.3.2015


Crixivan


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


EU/1/96/024


13.3.2015




11.3.2015


Glybera


uniQure biopharma B.V.
Meibergdreef 61, NL-1105 BA Amsterdam, Nederland


EU/1/12/791


13.3.2015




11.3.2015


Jakavi


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/12/773


13.3.2015




11.3.2015


Levetiracetam Hospira


Hospira UK Limited
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom


EU/1/13/889


13.3.2015




16.3.2015


Betmiga


Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland


EU/1/12/809


18.3.2015




16.3.2015


Desloratadine Actavis


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


EU/1/11/745


18.3.2015




16.3.2015


Emadine


Alcon Laboratories (UK) Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom


EU/1/98/095


18.3.2015




16.3.2015


Esmya


Gedeon Richter Plc.
Gyömrői út 19-21., H-1103 Budapest, Magyarország


EU/1/12/750


18.3.2015




16.3.2015


Evoltra


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


EU/1/06/334


18.3.2015




16.3.2015


Omnitrope


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/06/332


18.3.2015




16.3.2015


Zerit


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


EU/1/96/009


18.3.2015




19.3.2015


Azarga


Alcon Laboratories (UK) Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom


EU/1/08/482


23.3.2015




19.3.2015


Effentora


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


EU/1/08/441


24.3.2015




19.3.2015


Ibandronic acid Sandoz


Sandoz Pharmaceuticals GmbH
Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland


EU/1/11/685


23.3.2015




19.3.2015


Orphacol


Laboratoires CTRS
63 rue de l'Est, F-92100 Boulogne-Billancourt, France


EU/1/13/870


24.3.2015




19.3.2015


Rienso


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


EU/1/12/774


23.3.2015




19.3.2015


Sprycel


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


EU/1/06/363


23.3.2015




19.3.2015


Tolura


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


EU/1/10/632


23.3.2015




19.3.2015


Victoza


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


EU/1/09/529


23.3.2015




19.3.2015


Viread


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/01/200


23.3.2015




23.3.2015


Actraphane


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


EU/1/02/229


25.3.2015




23.3.2015


Daliresp


Takeda GmbH
Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland


EU/1/11/668


25.3.2015




23.3.2015


Ibandronic acid Accord


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


EU/1/12/798


25.3.2015




23.3.2015


Leflunomide medac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6, D-22880 Wedel, Deutschland


EU/1/10/637


25.3.2015




23.3.2015


Libertek


Takeda GmbH
Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland


EU/1/11/666


25.3.2015




23.3.2015


Ozurdex


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


EU/1/10/638


25.3.2015




23.3.2015


Pixuvri


CTI Life Sciences Ltd
Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom


EU/1/12/764


25.3.2015




23.3.2015


Stocrin


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


EU/1/99/111


25.3.2015




23.3.2015


Xeplion


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


EU/1/11/672


25.3.2015




26.3.2015


Bondronat


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


EU/1/96/012


30.3.2015




26.3.2015


Humira


AbbVie Ltd
Maidenhead, SL6 4XE, United Kingdom


EU/1/03/256


30.3.2015




26.3.2015


Intelence


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


EU/1/08/468


30.3.2015




30.3.2015


Kaletra


AbbVie Ltd
Maidenhead, SL6 4XE, United Kingdom


EU/1/01/172


1.4.2015




30.3.2015


Nevanac


Alcon Laboratories (UK) Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom


EU/1/07/433


1.4.2015




30.3.2015


Soliris


Alexion Europe SAS
1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France


EU/1/07/393


1.4.2015




30.3.2015


Suboxone


RB Pharmaceuticals Limited
103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom


EU/1/06/359


1.4.2015




30.3.2015


Vectibix


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


EU/1/07/423


1.4.2015




—   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




5.3.2015


BindRen


Mitsubishi Tanabe Pharma Europe Ltd.
Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom


EU/1/12/804


9.3.2015




—   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




16.3.2015


Coliprotec F4


Live non-pathogenic Escherichia coli strain O8:K87


Prevtec Microbia GmbH
Geyerspergerstr 27, 80689 München, Deutschland


EU/2/14/180


Lyophilisate for oral suspension


QI09AE03


18.3.2015




—   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




5.3.2015


Advocate


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/03/039


9.3.2015




5.3.2015


Dexdomitor


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/2/02/033


9.3.2015




11.3.2015


Stronghold


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


EU/2/99/014


13.3.2015




16.3.2015


Zuprevo


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


EU/2/11/124


18.3.2015




26.3.2015


Nobivac Myxo-RHD


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


EU/2/11/132


30.3.2015




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





The European Medicines Agency




30, Churchill Place, Canary Wharf




UK — LONDON E14 5EU






(1)  OJ L 136, 30.4.2004, p. 1.