# Official Journal C 71/27 F

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 71 |
| | |
| English edition | Information and Notices | Volume 5827 February 2015 |

ISSN 1977-091X

Official Journal

of the European Union

C 71

English edition

Information and Notices

Volume 5827 February 2015

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2015/C 071/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2014 to 31 October 2014(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 071/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2015 to 31 January 2015(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 2 |
| 2015/C 071/03 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2015 to 31 January 2015(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 11 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2015/C 071/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2014 to 31 October 2014(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(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 071/02

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

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

2

2015/C 071/03

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2015 to 31 January 2015(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

11

---

| EN | |
| --- | --- |

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 27.2.2015 | EN | Official Journal of the European Union | C 71/1 |
| --- | --- | --- | --- |

27.2.2015

EN

Official Journal of the European Union

C 71/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2014 to 31 October 2014

(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 071/01)

—   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 |
| --- | --- | --- | --- | --- |
| 15.10.2014 | Advagraf | Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/07/387 | 17.10.2014 |
| 30.10.2014 | JETREA | ThromboGenics NV Gaston Geenslaan 1, B-3001 Leuven, België | EU/1/13/819 | 3.11.2014 |
| 30.10.2014 | NexoBrid | MediWound Germany GmbH Eisenstr. 5, D-65428 Ruesselsheim, Deutschland | EU/1/12/803 | 3.11.2014 |

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

15.10.2014

Advagraf

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

EU/1/07/387

17.10.2014

30.10.2014

JETREA

ThromboGenics NV Gaston Geenslaan 1, B-3001 Leuven, België

EU/1/13/819

3.11.2014

30.10.2014

NexoBrid

MediWound Germany GmbH Eisenstr. 5, D-65428 Ruesselsheim, Deutschland

EU/1/12/803

3.11.2014

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

---

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

---

| 27.2.2015 | EN | Official Journal of the European Union | C 71/2 |
| --- | --- | --- | --- |

27.2.2015

EN

Official Journal of the European Union

C 71/2

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2015 to 31 January 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 071/02)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.1.2015 | Rasagiline ratiopharm | rasagiline | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/977 | Tablet | N04BD02 | 14.1.2015 |
| 15.1.2015 | Cosentyx | secukinumab | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/980 | Powder and solution for injection
  Solution for injection in a pre-filled syringe
  Solution for injection in pre-filled pen | L04AC10 | 19.1.2015 |
| 15.1.2015 | Exviera | dasabuvir | AbbVie Ltd
  Maidenhead, SL6 4XE, United Kingdom | EU/1/14/983 | Film-coated tablet | Pending | 19.1.2015 |
| 15.1.2015 | Ofev | Nintedanib | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | Capsule, soft | L01XE31 | 19.1.2015 |
| 15.1.2015 | Otezla | apremilast | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/14/981 | Film-coated tablet | L04AA32 | 16.1.2015 |
| 15.1.2015 | Senshio | ospemifene | Shionogi Limited
  33 Kingsway, London WC2B 6UF, United Kingdom | EU/1/14/978 | Film-coated tablet | G03XC05 | 19.1.2015 |
| 15.1.2015 | Sevelamer carbonate Zentiva | Sevelamer carbonate | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/14/952 | Film-coated tablet
  Powder for oral suspension | V03AE02 | 19.1.2015 |
| 15.1.2015 | Vectibix | panitumumab | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/07/423 | Concentrate for solution for infusion | L01XC08 | 19.1.2015 |
| 15.1.2015 | Viekirax | ombitasvir/paritaprevir/ritonavir | AbbVie Ltd
  Maidenhead, SL6 4XE, United Kingdom | EU/1/14/982 | Film-coated tablet | Pending | 19.1.2015 |
| 19.1.2015 | Cerdelga | eliglustat | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/14/974 | Capsule, hard | A16AX10 | 21.1.2015 |
| 19.1.2015 | Zontivity | vorapaxar | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/14/976 | Film-coated tablet | Pending | 21.1.2015 |

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

12.1.2015

Rasagiline ratiopharm

rasagiline

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/977

Tablet

N04BD02

14.1.2015

15.1.2015

Cosentyx

secukinumab

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/980

Powder and solution for injection

Solution for injection in a pre-filled syringe

Solution for injection in pre-filled pen

L04AC10

19.1.2015

15.1.2015

Exviera

dasabuvir

AbbVie Ltd

Maidenhead, SL6 4XE, United Kingdom

EU/1/14/983

Film-coated tablet

Pending

19.1.2015

15.1.2015

Ofev

Nintedanib

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

Capsule, soft

L01XE31

19.1.2015

15.1.2015

Otezla

apremilast

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/14/981

Film-coated tablet

L04AA32

16.1.2015

15.1.2015

Senshio

ospemifene

Shionogi Limited

33 Kingsway, London WC2B 6UF, United Kingdom

EU/1/14/978

Film-coated tablet

G03XC05

19.1.2015

15.1.2015

Sevelamer carbonate Zentiva

Sevelamer carbonate

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/14/952

Film-coated tablet

Powder for oral suspension

V03AE02

19.1.2015

15.1.2015

Vectibix

panitumumab

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/07/423

Concentrate for solution for infusion

L01XC08

19.1.2015

15.1.2015

Viekirax

ombitasvir/paritaprevir/ritonavir

AbbVie Ltd

Maidenhead, SL6 4XE, United Kingdom

EU/1/14/982

Film-coated tablet

Pending

19.1.2015

19.1.2015

Cerdelga

eliglustat

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/14/974

Capsule, hard

A16AX10

21.1.2015

19.1.2015

Zontivity

vorapaxar

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/14/976

Film-coated tablet

Pending

21.1.2015

—   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 |
| --- | --- | --- | --- | --- |
| 7.1.2015 | ellaOne | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/09/522 | 9.1.2015 |
| 12.1.2015 | Defitelio | Gentium S.p.A.
  Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia | EU/1/13/878 | 14.1.2015 |
| 12.1.2015 | Emselex | Merus Labs Luxco S.à R.L.
  26-28, rue Edward Steichen, L-2540 Luxembourg | EU/1/04/294 | 14.1.2015 |
| 12.1.2015 | ProQuad | Sanofi Pasteur MSD, SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/05/323 | 14.1.2015 |
| 12.1.2015 | Savene | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/06/350 | 14.1.2015 |
| 12.1.2015 | Temozolomide Hospira | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/615 | 14.1.2015 |
| 12.1.2015 | Tracleer | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220 | 14.1.2015 |
| 12.1.2015 | Zostavax | Sanofi Pasteur MSD, SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/341 | 14.1.2015 |
| 15.1.2015 | Advate | Baxter AG
  Industriestraße 67, A-1221 Wien, Österreich | EU/1/03/271 | 19.1.2015 |
| 15.1.2015 | Byetta | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/06/362 | 19.1.2015 |
| 15.1.2015 | Caprelsa | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/749 | 19.1.2015 |
| 15.1.2015 | Cholib | Abbott Healthcare Products Ltd
  Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom | EU/1/13/866 | 19.1.2015 |
| 15.1.2015 | Corlentor | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes CEDEX, France | EU/1/05/317 | 19.1.2015 |
| 15.1.2015 | Focetria | Novartis Vaccines and Diagnostics S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/07/385 | 19.1.2015 |
| 15.1.2015 | Iclusig | ARIAD Pharma Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 19.1.2015 |
| 15.1.2015 | Incresync | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/842 | 19.1.2015 |
| 15.1.2015 | Latuda | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/913 | 19.1.2015 |
| 15.1.2015 | Matever | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/11/711 | 19.1.2015 |
| 15.1.2015 | Memantine ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/13/836 | 19.1.2015 |
| 15.1.2015 | Nivestim | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/631 | 19.1.2015 |
| 15.1.2015 | Opsumit | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/13/893 | 17.1.2015 |
| 15.1.2015 | Picato | Leo Pharma A/S
  Industriparken 55, DK-2750 Ballerup, Danmark | EU/1/12/796 | 19.1.2015 |
| 15.1.2015 | Procoralan | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes CEDEX, France | EU/1/05/316 | 19.1.2015 |
| 15.1.2015 | Prolia | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/10/618 | 19.1.2015 |
| 15.1.2015 | Revolade | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/10/612 | 19.1.2015 |
| 15.1.2015 | SANCUSO | ProStrakan Limited
  Galabank Business Park, Galashiels TD1 1QH, United Kingdom | EU/1/12/766 | 19.1.2015 |
| 15.1.2015 | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, NL-2333 CB Leiden, Nederland | EU/1/09/546 | 19.1.2015 |
| 15.1.2015 | TOBI Podhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/652 | 19.1.2015 |
| 15.1.2015 | Vipdomet | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/843 | 19.1.2015 |
| 15.1.2015 | Vipidia | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/844 | 19.1.2015 |
| 15.1.2015 | Votrient | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/10/628 | 19.1.2015 |
| 15.1.2015 | Zoledronic acid medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/779 | 19.1.2015 |
| 19.1.2015 | Aclasta | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/308 | 21.1.2015 |
| 19.1.2015 | BYDUREON | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/696 | 21.1.2015 |
| 19.1.2015 | Cometriq | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/13/890 | 21.1.2015 |
| 19.1.2015 | Gliolan | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/07/413 | 21.1.2015 |
| 19.1.2015 | Optaflu | Novartis Vaccines and Diagnostics GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/07/394 | 21.1.2015 |
| 19.1.2015 | Sirturo | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/901 | 21.1.2015 |
| 22.1.2015 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | EU/1/07/430 | 26.1.2015 |
| 22.1.2015 | Incivo | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/720 | 26.1.2015 |
| 22.1.2015 | Lyrica | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/04/279 | 26.1.2015 |
| 22.1.2015 | Spedra | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/13/841 | 26.1.2015 |
| 27.1.2015 | Evicel | Omrix Biopharmaceuticals N.V.
  Leonardo Da Vincilaan 15, B-1831 Diegem, België | EU/1/08/473 | 29.1.2015 |
| 27.1.2015 | Levetiracetam Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/11/701 | 30.1.2015 |
| 27.1.2015 | Myfenax | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/438 | 30.1.2015 |
| 27.1.2015 | Myocet | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/00/141 | 30.1.2015 |
| 27.1.2015 | Pramipexole Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/08/490 | 30.1.2015 |
| 27.1.2015 | VPRIV | Shire Pharmaceuticals Ireland Limited
  5 River Walk, Citywest Business Campus, Dublin 24, Ireland | EU/1/10/646 | 29.1.2015 |
| 27.1.2015 | Yellox | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Czech Republic | EU/1/11/692 | 29.1.2015 |
| 30.1.2015 | Clopidogrel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/540 | 3.2.2015 |
| 30.1.2015 | Pioglitazone Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/757 | 3.2.2015 |
| 30.1.2015 | Pioglitazone Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/758 | 3.2.2015 |
| 30.1.2015 | Tresiba | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/807 | 3.2.2015 |
| 30.1.2015 | Trisenox | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/02/204 | 5.2.2015 |
| 30.1.2015 | VELCADE | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/04/274 | 3.2.2015 |
| 30.1.2015 | Xiapex | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/11/671 | 3.2.2015 |

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

7.1.2015

ellaOne

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/09/522

9.1.2015

12.1.2015

Defitelio

Gentium S.p.A.

Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia

EU/1/13/878

14.1.2015

12.1.2015

Emselex

Merus Labs Luxco S.à R.L.

26-28, rue Edward Steichen, L-2540 Luxembourg

EU/1/04/294

14.1.2015

12.1.2015

ProQuad

Sanofi Pasteur MSD, SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/05/323

14.1.2015

12.1.2015

Savene

Clinigen Healthcare Limited

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

EU/1/06/350

14.1.2015

12.1.2015

Temozolomide Hospira

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/615

14.1.2015

12.1.2015

Tracleer

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/220

14.1.2015

12.1.2015

Zostavax

Sanofi Pasteur MSD, SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/341

14.1.2015

15.1.2015

Advate

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

EU/1/03/271

19.1.2015

15.1.2015

Byetta

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/06/362

19.1.2015

15.1.2015

Caprelsa

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/749

19.1.2015

15.1.2015

Cholib

Abbott Healthcare Products Ltd

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

EU/1/13/866

19.1.2015

15.1.2015

Corlentor

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/05/317

19.1.2015

15.1.2015

Focetria

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/07/385

19.1.2015

15.1.2015

Iclusig

ARIAD Pharma Ltd

Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom

EU/1/13/839

19.1.2015

15.1.2015

Incresync

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/842

19.1.2015

15.1.2015

Latuda

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/913

19.1.2015

15.1.2015

Matever

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/11/711

19.1.2015

15.1.2015

Memantine ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/13/836

19.1.2015

15.1.2015

Nivestim

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/631

19.1.2015

15.1.2015

Opsumit

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/13/893

17.1.2015

15.1.2015

Picato

Leo Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/12/796

19.1.2015

15.1.2015

Procoralan

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/05/316

19.1.2015

15.1.2015

Prolia

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618

19.1.2015

15.1.2015

Revolade

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/10/612

19.1.2015

15.1.2015

SANCUSO

ProStrakan Limited

Galabank Business Park, Galashiels TD1 1QH, United Kingdom

EU/1/12/766

19.1.2015

15.1.2015

Simponi

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/09/546

19.1.2015

15.1.2015

TOBI Podhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/652

19.1.2015

15.1.2015

Vipdomet

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/843

19.1.2015

15.1.2015

Vipidia

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/844

19.1.2015

15.1.2015

Votrient

Glaxo Group Ltd

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

EU/1/10/628

19.1.2015

15.1.2015

Zoledronic acid medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/779

19.1.2015

19.1.2015

Aclasta

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/308

21.1.2015

19.1.2015

BYDUREON

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/696

21.1.2015

19.1.2015

Cometriq

TMC Pharma Services Ltd

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom

EU/1/13/890

21.1.2015

19.1.2015

Gliolan

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/07/413

21.1.2015

19.1.2015

Optaflu

Novartis Vaccines and Diagnostics GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/07/394

21.1.2015

19.1.2015

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/901

21.1.2015

22.1.2015

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430

26.1.2015

22.1.2015

Incivo

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/720

26.1.2015

22.1.2015

Lyrica

Pfizer Limited

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

EU/1/04/279

26.1.2015

22.1.2015

Spedra

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/13/841

26.1.2015

27.1.2015

Evicel

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15, B-1831 Diegem, België

EU/1/08/473

29.1.2015

27.1.2015

Levetiracetam Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/11/701

30.1.2015

27.1.2015

Myfenax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/438

30.1.2015

27.1.2015

Myocet

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/00/141

30.1.2015

27.1.2015

Pramipexole Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/490

30.1.2015

27.1.2015

VPRIV

Shire Pharmaceuticals Ireland Limited

5 River Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/10/646

29.1.2015

27.1.2015

Yellox

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Czech Republic

EU/1/11/692

29.1.2015

30.1.2015

Clopidogrel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/540

3.2.2015

30.1.2015

Pioglitazone Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/757

3.2.2015

30.1.2015

Pioglitazone Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/758

3.2.2015

30.1.2015

Tresiba

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/807

3.2.2015

30.1.2015

Trisenox

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/02/204

5.2.2015

30.1.2015

VELCADE

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274

3.2.2015

30.1.2015

Xiapex

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/11/671

3.2.2015

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 15.1.2015 | NEXGARD SPECTRA | Afoxolaner/milbemycin oxime | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/14/177 | Chewable tablet | QP54AB51 | 19.1.2015 |

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

15.1.2015

NEXGARD SPECTRA

Afoxolaner/milbemycin oxime

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/14/177

Chewable tablet

QP54AB51

19.1.2015

—   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 |
| --- | --- | --- | --- | --- |
| 12.1.2015 | Coxevac | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/10/110 | 14.1.2015 |
| 15.1.2015 | BLUEVAC BTV8 | CZ Veterinaria, S.A.
  La Relva s/n, P.O. Box 16, E-36400 Porriño, España | EU/2/11/122 | 19.1.2015 |
| 30.1.2015 | Emdocam | Emdoka bvba
  J. Lijsenstraat 16, B-2321 Hoogstraten, België | EU/2/11/128 | 3.2.2015 |

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

12.1.2015

Coxevac

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

EU/2/10/110

14.1.2015

15.1.2015

BLUEVAC BTV8

CZ Veterinaria, S.A.

La Relva s/n, P.O. Box 16, E-36400 Porriño, España

EU/2/11/122

19.1.2015

30.1.2015

Emdocam

Emdoka bvba

J. Lijsenstraat 16, B-2321 Hoogstraten, België

EU/2/11/128

3.2.2015

—   Withdrawal of a marketing authorisation (Article 38 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 |
| --- | --- | --- | --- | --- |
| 15.1.2015 | Slentrol | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/07/071 | 19.1.2015 |
| 15.1.2015 | TruScient | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/136 | 19.1.2015 |

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

15.1.2015

Slentrol

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/07/071

19.1.2015

15.1.2015

TruScient

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/11/136

19.1.2015

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

---

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

---

| 27.2.2015 | EN | Official Journal of the European Union | C 71/11 |
| --- | --- | --- | --- |

27.2.2015

EN

Official Journal of the European Union

C 71/11

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2015 to 31 January 2015

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2015/C 071/03)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 12.1.2015 | Seasonique | See Annex I | See Annex I | See Annex I | 13.1.2015 |
| 19.1.2015 | Nasonex | See Annex II | See Annex II | See Annex II | 20.1.2015 |
| 12.1.2015 | Dexrazonane | Dexrazoxane | Not applicable | Not applicable | 13.1.2015 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

12.1.2015

Seasonique

See Annex I

See Annex I

See Annex I

13.1.2015

19.1.2015

Nasonex

See Annex II

See Annex II

See Annex II

20.1.2015

12.1.2015

Dexrazonane

Dexrazoxane

Not applicable

Not applicable

13.1.2015

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States

| Member State EU/EEA | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Teva Pharma B.V. Computerweg 10
  3542 DR Utrecht
  The Netherlands | Seasonique Filmtabletten | 0,15/0,03 mg and 0,01 mg | film-coated tablet | oral use |
| Belgium | Teva Pharma B.V. Computerweg 10
  3542 DR Utrecht
  The Netherlands | Seasonique 0,15 mg/0,03 mg filmomhulde tabletten en 0,01 mg filmomhulde tabletten | 0,15/0,03 mg and 0,01 mg | film-coated tablet | oral use |
| France | Teva Pharma B.V. Computerweg 10
  3542 DR Utrecht
  The Netherlands | Seasonique | 0,15/0,03 mg and 0,01 mg | film-coated tablet | oral use |
| Germany | Teva Pharma B.V. Computerweg 10
  3542 DR Utrecht
  The Netherlands | Seasonique | 0,15/0,03 mg and 0,01 mg | film-coated tablet | oral use |
| Italy | Teva Pharma B.V. Computerweg 10
  3542 DR Utrecht
  The Netherlands | Seasonique | 0,15/0,03 mg and 0,01 mg | film-coated tablet | oral use |
| Poland | Teva Pharma B.V. Computerweg 10
  3542 DR Utrecht
  The Netherlands | Seasonique | 0,15/0,03 mg and 0,01 mg | film-coated tablet | oral use |
| Romania | Teva Pharma B.V. Computerweg 10
  3542 DR Utrecht
  The Netherlands | SEASONIQUE 150 micrograme/30 micrograme şi 10 micrograme comprimate filmate | 0,15/0,03 mg and 0,01 mg | film-coated tablet | oral use |
| Slovak Republic | Teva Pharma B.V. Computerweg 10
  3542 DR Utrecht
  The Netherlands | Seasonique | 0,15/0,03 mg and 0,01 mg | film-coated tablet | oral use |
| Slovenia | Teva Pharma B.V. Computerweg 10
  3542 DR Utrecht
  The Netherlands | Seasonique 0,15 mg/0,03 mg in 0,01 mg filmsko obložene tablete | 0,15/0,03 mg and 0,01 mg | film-coated tablet | oral use |

Member State EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht

The Netherlands

Seasonique Filmtabletten

0,15/0,03 mg and 0,01 mg

film-coated tablet

oral use

Belgium

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht

The Netherlands

Seasonique 0,15 mg/0,03 mg filmomhulde tabletten en 0,01 mg filmomhulde tabletten

0,15/0,03 mg and 0,01 mg

film-coated tablet

oral use

France

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht

The Netherlands

Seasonique

0,15/0,03 mg and 0,01 mg

film-coated tablet

oral use

Germany

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht

The Netherlands

Seasonique

0,15/0,03 mg and 0,01 mg

film-coated tablet

oral use

Italy

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht

The Netherlands

Seasonique

0,15/0,03 mg and 0,01 mg

film-coated tablet

oral use

Poland

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht

The Netherlands

Seasonique

0,15/0,03 mg and 0,01 mg

film-coated tablet

oral use

Romania

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht

The Netherlands

SEASONIQUE 150 micrograme/30 micrograme şi 10 micrograme comprimate filmate

0,15/0,03 mg and 0,01 mg

film-coated tablet

oral use

Slovak Republic

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht

The Netherlands

Seasonique

0,15/0,03 mg and 0,01 mg

film-coated tablet

oral use

Slovenia

Teva Pharma B.V. Computerweg 10

3542 DR Utrecht

The Netherlands

Seasonique 0,15 mg/0,03 mg in 0,01 mg filmsko obložene tablete

0,15/0,03 mg and 0,01 mg

film-coated tablet

oral use

---

ANNEX II

List of the names, pharmaceutical form, strength of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States

| Member State
  EU/EEA | Marketing authorisation holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Merck Sharp & Dohme Ges.m.b.H.
  Am Euro Platz 2
  1120 Wien
  Austria | Nasonex aquosum — Nasenspray | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Belgium | MSD Belgium BVBA/SPRL
  Clos du Lynx 5
  B-1200 Bruxelles
  Belgium | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Bulgaria | Merck Sharp and Dohme Bulgaria EOOD
  55, Nikola Vaptzarov blvd.
  EXPO 2000, East Wing, Sectors B1 & B2
  1407 Sofia
  Bulgaria | NASONEX | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Croatia | Merck Sharp & Dohme d.o.o.
  Heinzelova 62a
  10 000 Zagreb
  Croatia | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Czech Republic | Merck Sharp & Dohme B.V.
  Waarderweg 39
  2031 BN Haarlem
  The Netherlands | NASONEX | 50 μg/
  dose | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Denmark | Merck Sharp & Dohme BV
  Waarderweg 39
  Postbox 581
  2003 PC Haarlem
  The Netherlands | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Estonia | Merck Sharp & Dohme B.V.
  Waarderweg 39
  2031 BN Haarlem
  The Netherlands | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Finland | Merck Sharp & Dohme B.V.
  Box 581
  2003 PC Haarlem
  The Netherlands | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| France | MSD France
  34 avenue Léonard de Vinci
  92400 Courbevoie
  France | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Germany | MSD SHARP & DOHME GMBH
  Lindenplatz 1
  85540 Haar
  Germany | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Greece | Merck Sharp & Dohme S.A.
  Ag. Dimitriou 63
  174 56 Alimos
  Greece | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Hungary | MSD Pharma Hungary Kft.
  H-1095 Budapest
  Lechner Ödön fasor 8.
  Hungary | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Iceland | Merck Sharp & Dohme B.V.
  Box 581
  2003 PC Haarlem
  The Netherlands | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Ireland | Merck Sharp & Dohme Ireland (Human Health) Limited
  Red Oak North
  South County Business Park
  Leopardstown
  Dublin 18
  Ireland | Nasonex | 50 μg/
  actuation | Nasal Spray, Suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Italy | MSD Italia S.r.l.
  Via Vitorchiano 151
  00189 Roma
  Italy | Nasonex | 50 μg/
  actuation | Nasal Spray, Suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Italy | Malesci Istituto Farmacobiologico S.p.A
  Via Lungo l’Ema 7
  Bagno a Ripoli (FI)
  Italy | Rinelon | 50 μg/
  actuation | Nasal Spray, Suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Latvia | Merck Sharp & Dohme B.V.
  Waarderweg 39
  2031 BN Haarlem
  The Netherlands | Nasonex 50 mikrogrami/devā deguna aerosols, suspensija | 50 μg/
  dose | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Lithuania | Merck Sharp & Dohme B.V.
  Waarderweg 39
  2031 BN Haarlem
  The Netherlands | Nasonex | 50 μg/
  dose | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate (monohydrate) calculated on the anhydrous basis |
| Luxembourg | MSD Belgium BVBA/SPRL
  Clos du Lynx 5
  B-1200 Bruxelles
  Belgium | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Malta | Merck Sharp & Dohme Ltd.
  Hertford Road
  Hoddesdon
  Hertfordshire
  EN11 9BU
  United Kingdom | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Netherlands | Merck Sharp & Dohme B.V.
  Waarderweg 39
  2031 BN Haarlem
  The Netherlands | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Norway | Merck Sharp & Dohme B.V.
  Waarderweg 39
  2031 BN Haarlem
  The Netherlands | Nasonex | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Poland | MSD Polska Sp. z o.o.
  ul. Chłodna 51
  00-867 Warszawa
  Poland | Nasonex | 50 μg/
  dose | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Portugal | Merck Sharp & Dohme, Lda.
  Quinta da Fonte, 19
  Edifício Vasco da Gama
  2770-192 Paço de Arcos
  Portugal | Nasomet | 50 μg/
  dose | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Romania | MERCK SHARP & DOHME ROMANIA S.R.L.
  Bucharest Business Park
  Şos. Bucureşti-Ploieşti Nr. 1A, Clădirea C1, Etaj 3,
  Sector 1, Bucureşti
  Romania | NASONEX | 50 μg/
  dose | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Slovak Republic | Merck Sharp & Dohme B.V.
  Waarderweg 39
  2031 BN Haarlem
  P.O. Box 581
  2003 PC Haarlem
  The Netherlands | NASONEX | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Slovenia | Merck Sharp & Dohme, inovativna zdravila d.o.o.
  Šmartinska cesta 140
  1000 Ljubljana
  Slovenia | NASONEX | 50 μg/
  actuation | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Spain | Merck Sharp & Dohme de España, S.A.
  C/Josefa Valcárcel, 38 28027 Madrid
  Spain | NASONEX 50 microgramos suspension para pulverización nasal | 50 μg/
  actuation | Nasal Spray, Suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Spain | Desarrollos Farmacéuticos y Cosméticos, S.A.
  C/Josefa Valcárcel, 38 28027 Madrid
  Spain | Mometasona MSD 50 microgramos suspensión para pulverización nasal | 50 μg/
  actuation | Nasal Spray, Suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| Sweden | Merck Sharp & Dohme B.V.
  Box 581
  2003 PC Haarlem
  The Netherlands | Nasonex | 50 μg/
  dose | Nasal spray, suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |
| United Kingdom | Merck Sharp & Dohme Ltd
  Hertford Road
  Hoddesdon
  Hertfordshire
  EN11 9BU
  United Kingdom | Nasonex | 50 μg/
  actuation | Nasal Spray, Suspension | Nasal use | 0,05 % w/w Mometasone furoate calculated on the anhydrous basis |

Member State

EU/EEA

Marketing authorisation holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content (concentration)

Austria

Merck Sharp & Dohme Ges.m.b.H.

Am Euro Platz 2

1120 Wien

Austria

Nasonex aquosum — Nasenspray

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Belgium

MSD Belgium BVBA/SPRL

Clos du Lynx 5

B-1200 Bruxelles

Belgium

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Bulgaria

Merck Sharp and Dohme Bulgaria EOOD

55, Nikola Vaptzarov blvd.

EXPO 2000, East Wing, Sectors B1 & B2

1407 Sofia

Bulgaria

NASONEX

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Croatia

Merck Sharp & Dohme d.o.o.

Heinzelova 62a

10 000 Zagreb

Croatia

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Czech Republic

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

NASONEX

50 μg/

dose

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Denmark

Merck Sharp & Dohme BV

Waarderweg 39

Postbox 581

2003 PC Haarlem

The Netherlands

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Estonia

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Finland

Merck Sharp & Dohme B.V.

Box 581

2003 PC Haarlem

The Netherlands

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

France

MSD France

34 avenue Léonard de Vinci

92400 Courbevoie

France

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Germany

MSD SHARP & DOHME GMBH

Lindenplatz 1

85540 Haar

Germany

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Greece

Merck Sharp & Dohme S.A.

Ag. Dimitriou 63

174 56 Alimos

Greece

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Hungary

MSD Pharma Hungary Kft.

H-1095 Budapest

Lechner Ödön fasor 8.

Hungary

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Iceland

Merck Sharp & Dohme B.V.

Box 581

2003 PC Haarlem

The Netherlands

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Red Oak North

South County Business Park

Leopardstown

Dublin 18

Ireland

Nasonex

50 μg/

actuation

Nasal Spray, Suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Italy

MSD Italia S.r.l.

Via Vitorchiano 151

00189 Roma

Italy

Nasonex

50 μg/

actuation

Nasal Spray, Suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Italy

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7

Bagno a Ripoli (FI)

Italy

Rinelon

50 μg/

actuation

Nasal Spray, Suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Latvia

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Nasonex 50 mikrogrami/devā deguna aerosols, suspensija

50 μg/

dose

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Lithuania

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Nasonex

50 μg/

dose

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate (monohydrate) calculated on the anhydrous basis

Luxembourg

MSD Belgium BVBA/SPRL

Clos du Lynx 5

B-1200 Bruxelles

Belgium

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Malta

Merck Sharp & Dohme Ltd.

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

United Kingdom

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Netherlands

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Norway

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Nasonex

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Poland

MSD Polska Sp. z o.o.

ul. Chłodna 51

00-867 Warszawa

Poland

Nasonex

50 μg/

dose

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Portugal

Merck Sharp & Dohme, Lda.

Quinta da Fonte, 19

Edifício Vasco da Gama

2770-192 Paço de Arcos

Portugal

Nasomet

50 μg/

dose

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Romania

MERCK SHARP & DOHME ROMANIA S.R.L.

Bucharest Business Park

Şos. Bucureşti-Ploieşti Nr. 1A, Clădirea C1, Etaj 3,

Sector 1, Bucureşti

Romania

NASONEX

50 μg/

dose

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Slovak Republic

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

P.O. Box 581

2003 PC Haarlem

The Netherlands

NASONEX

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Slovenia

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Šmartinska cesta 140

1000 Ljubljana

Slovenia

NASONEX

50 μg/

actuation

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Spain

Merck Sharp & Dohme de España, S.A.

C/Josefa Valcárcel, 38 28027 Madrid

Spain

NASONEX 50 microgramos suspension para pulverización nasal

50 μg/

actuation

Nasal Spray, Suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Spain

Desarrollos Farmacéuticos y Cosméticos, S.A.

C/Josefa Valcárcel, 38 28027 Madrid

Spain

Mometasona MSD 50 microgramos suspensión para pulverización nasal

50 μg/

actuation

Nasal Spray, Suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

Sweden

Merck Sharp & Dohme B.V.

Box 581

2003 PC Haarlem

The Netherlands

Nasonex

50 μg/

dose

Nasal spray, suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

United Kingdom

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

United Kingdom

Nasonex

50 μg/

actuation

Nasal Spray, Suspension

Nasal use

0,05 % w/w Mometasone furoate calculated on the anhydrous basis

---