# C_2015148EN.01000401.xml

| 5.5.2015 | EN | Official Journal of the European Union | C 148/4 |
| --- | --- | --- | --- |

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))

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

Issuing of a marketing authorisation

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 |

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

Modification of a marketing authorization

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 |

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)

Withdrawal of a marketing authorization

| 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 |

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

Issuing of a marketing authorization

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 |

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

Modification of a marketing authorization

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 |

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 |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

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(1)  OJ L 136, 30.4.2004, p. 1.

1

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