# Official Journal C 165/29 M

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 165 |
| | |
| English edition | Information and Notices | Volume 5729 May 2014 |

ISSN 1977-091X

Official Journal

of the European Union

C 165

English edition

Information and Notices

Volume 5729 May 2014

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2014/C 165/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2014 to 30 April 2014(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2014/C 165/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2014 to 30 April 2014(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 9 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2014/C 165/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2014 to 30 April 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

2014/C 165/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2014 to 30 April 2014(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)

9

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.5.2014 | EN | Official Journal of the European Union | C 165/1 |
| --- | --- | --- | --- |

29.5.2014

EN

Official Journal of the European Union

C 165/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2014 to 30 April 2014

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

2014/C 165/01

—   Issuing 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 | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.4.2014 | Rivastigmine 3M Health Care Ltd. | rivastigmine | 3M Health Care Limited |
| 1 Morley Street, Loughborough, Leicestershire, LE11 1EP United Kingdom |

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

3.4.2014

Rivastigmine 3M Health Care Ltd.

rivastigmine

3M Health Care Limited

1 Morley Street, Loughborough, Leicestershire, LE11 1EP United Kingdom

EU/1/14/911

Transdermal patch

N06DA03

7.4.2014

4.4.2014

Cholic Acid FGK

cholic acid

FGK Representative Service GmbH

Heimeranstraße 35, D-80339 München, Deutschland

EU/1/13/895

Capsule, hard

A05AA03

8.4.2014

7.4.2014

Para-aminosalicylic acid Lucane

Para-aminosalicylic acid

| Lucane Pharma |
| --- |
| 172 rue de Charonne, 75011 Paris, France |

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/896

Gastro-resistant granules

J04AA01

9.4.2014

10.4.2014

Pregabalin Pfizer

pregabalin

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

Pfizer Limited

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

EU/1/14/916

Capsule, hard

N03AX16

14.4.2014

23.4.2014

Hemangiol

propranolol

| PIERRE FABRE DERMATOLOGIE |
| --- |
| 45 place Abel Gance, F- 92100 Boulogne, France |

PIERRE FABRE DERMATOLOGIE

45 place Abel Gance, F- 92100 Boulogne, France

EU/1/14/919

Oral solution

C07AA05

25.4.2014

23.4.2014

Ulunar Breezhaler

indacaterol/glycopyrronium bromide

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

Novartis Europharm Limited

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

EU/1/14/917

Inhalation powder, hard capsule

R03AL04

25.4.2014

23.4.2014

Vokanamet

canagliflozin/metformin hydrochloride

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/918

Film-coated tablet

A10BD16

25.4.2014

28.4.2014

BiResp Spiromax

budesonide/formoterol

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/921

Inhalation powder

R03AK07

1.5.2014

28.4.2014

Deltyba

delamanid

| Otsuka Novel Products GmbH |
| --- |
| Erika-Mann-Straße 21, D-80636 München, Deutschland |

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, D-80636 München, Deutschland

EU/1/13/875

Film-coated tablet

J04AK06

30.4.2014

28.4.2014

DuoResp Spiromax

budesonide/formoterol

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/920

Inhalation powder

R03AK07

1.5.2014

28.4.2014

Incruse

umeclidinium bromide

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

Glaxo Group Ltd

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

EU/1/14/922

Inhalation powder, pre-dispensed

R03BB07

30.4.2014

28.4.2014

Vimizim

elosulfase alfa

| BioMarin Europe Ltd |
| --- |
| 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom |

BioMarin Europe Ltd

164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/14/914

Concentrate and solvent for solution for infusion

A16AB12

30.4.2014

—   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 |
| --- | --- | --- | --- | --- |
| 3.4.2014 | Neuraceq | Piramal Imaging Limited |
| Suite no. 10, Innovation Center, Unit 23, Science Park, Cambridge CB4 0EY, United Kingdom |

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

3.4.2014

Neuraceq

Piramal Imaging Limited

Suite no. 10, Innovation Center, Unit 23, Science Park, Cambridge CB4 0EY, United Kingdom

EU/1/13/906

9.4.2014

3.4.2014

Xiapex

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

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/11/671

7.4.2014

7.4.2014

Exelon

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

Novartis Europharm Limited

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

EU/1/98/066

9.4.2014

10.4.2014

Abilify

| Otsuka Pharmaceutical Europe Ltd. |
| --- |
| Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/04/276

14.4.2014

10.4.2014

Clopidogrel Mylan

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

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/09/559

14.4.2014

10.4.2014

Lonquex

| UAB ‘Sicor Biotech’ |
| --- |
| V. A. Graičiūno g. 8 LT-02241 Vilnius, Lithuania |

UAB ‘Sicor Biotech’

V. A. Graičiūno g. 8 LT-02241 Vilnius, Lithuania

EU/1/13/856

15.4.2014

10.4.2014

Pixuvri

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

CTI Life Sciences Ltd

Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

14.4.2014

10.4.2014

Viramune

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

Boehringer Ingelheim International GmbH

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

EU/1/97/055

14.4.2014

11.4.2014

Grepid

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

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535

15.4.2014

11.4.2014

Mozobil

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/09/537

15.4.2014

11.4.2014

Victoza

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/09/529

15.4.2014

15.4.2014

Osseor

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France |

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/04/287

17.4.2014

15.4.2014

Protelos

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France |

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/04/288

17.4.2014

23.4.2014

Aloxi

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

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/04/306

25.4.2014

23.4.2014

Betmiga

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

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/12/809

25.4.2014

23.4.2014

Bretaris Genuair

| Almirall, S.A. |
| --- |
| Ronda General Mitre, 151, E-08022 Barcelona, España |

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/12/781

25.4.2014

23.4.2014

CANCIDAS

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

Merck Sharp & Dohme Limited

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

EU/1/01/196

25.4.2014

23.4.2014

Eklira Genuair

| Almirall, S.A. |
| --- |
| Ronda General Mitre, 151, E-08022 Barcelona, España |

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/12/778

25.4.2014

23.4.2014

Elaprase

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D, SE-182 33 Danderyd, Sverige |

Shire Human Genetic Therapies AB

Svärdvägen 11D, SE-182 33 Danderyd, Sverige

EU/1/06/365

25.4.2014

23.4.2014

Ferriprox

| Apotex Europe B.V. |
| --- |
| Darwinweg 20, NL- 2333 CR Leiden, Nederland |

Apotex Europe B.V.

Darwinweg 20, NL- 2333 CR Leiden, Nederland

EU/1/99/108

25.4.2014

23.4.2014

Instanyl

| Takeda Pharma A/S |
| --- |
| Langebjerg 1, DK-4000 Roskilde, Danmark |

Takeda Pharma A/S

Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/09/531

25.4.2014

23.4.2014

Integrilin

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

Glaxo Group Ltd

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

EU/1/99/109

25.4.2014

23.4.2014

Iressa

| AstraZeneca AB |
| --- |
| SE-151 85 Södertälje, Sverige |

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/09/526

25.4.2014

23.4.2014

Ketek

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

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony CEDEX, France

EU/1/01/191

25.4.2014

23.4.2014

Nimenrix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/12/767

25.4.2014

23.4.2014

Noxafil

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

Merck Sharp & Dohme Limited

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

EU/1/05/320

28.4.2014

23.4.2014

Onglyza

| Bristol-Myers Squibb/AstraZeneca EEIG |
| --- |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Bristol-Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/09/545

25.4.2014

23.4.2014

Pegasys

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

Roche Registration Limited

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

EU/1/02/221

25.4.2014

23.4.2014

Qutenza

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

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/09/524

25.4.2014

23.4.2014

Rivastigmine HEXAL

| Hexal AG |
| --- |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland |

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/09/589

25.4.2014

23.4.2014

RoActemra

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

Roche Registration Limited

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

EU/1/08/492

28.4.2014

23.4.2014

Ryzodeg

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/806

25.4.2014

23.4.2014

Siklos

| Addmedica |
| --- |
| 101 rue Saint Lazare, F-75009 Paris, France |

Addmedica

101 rue Saint Lazare, F-75009 Paris, France

EU/1/07/397

25.4.2014

23.4.2014

Stocrin

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

Merck Sharp & Dohme Limited

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

EU/1/99/111

25.4.2014

23.4.2014

Sustiva

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/99/110

25.4.2014

23.4.2014

Vedrop

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

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/09/533

25.4.2014

23.4.2014

Vfend

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

Pfizer Limited

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

EU/1/02/212

28.4.2014

23.4.2014

Volibris

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

Glaxo Group Ltd

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

EU/1/08/451

25.4.2014

28.4.2014

alli

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

Glaxo Group Ltd

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

EU/1/07/401

30.4.2014

28.4.2014

Avamys

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

Glaxo Group Ltd

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

EU/1/07/434

30.4.2014

28.4.2014

Exjade

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

Novartis Europharm Limited

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

EU/1/06/356

30.4.2014

28.4.2014

Glybera

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

uniQure biopharma B.V.

Meibergdreef 61, NL-1105 BA Amsterdam, Nederland

EU/1/12/791

30.4.2014

28.4.2014

Orencia

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/07/389

30.4.2014

28.4.2014

Pegasys

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

Roche Registration Limited

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

EU/1/02/221

30.4.2014

28.4.2014

Rebetol

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

Merck Sharp & Dohme Limited

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

EU/1/99/107

30.4.2014

28.4.2014

Ribavirin Mylan

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

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/10/634

30.4.2014

28.4.2014

Ribavirin Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/509

1.5.2014

28.4.2014

Ribavirin Teva Pharma BV

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/527

1.5.2014

28.4.2014

Rivastigmine Sandoz

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland

EU/1/09/599

30.4.2014

28.4.2014

Tepadina

| ADIENNE S.r.l. |
| --- |
| Via Galileo Galilei 19, 20867 Caponago (MB), Italia |

ADIENNE S.r.l.

Via Galileo Galilei 19, 20867 Caponago (MB), Italia

EU/1/10/622

30.4.2014

28.4.2014

Victoza

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/09/529

30.4.2014

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2)): 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.4.2014 | Parvoduk | Live attenuated Muscovy duck parvovirus | Merial |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

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

11.4.2014

Parvoduk

Live attenuated Muscovy duck parvovirus

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/14/162

Suspension and diluent for suspension for injection

QI01BD03

15.4.2014

—   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 |
| --- | --- | --- | --- | --- |
| 7.4.2014 | Aftovaxpur Doe | Merial |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

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

7.4.2014

Aftovaxpur Doe

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/153

9.4.2014

10.4.2014

Equilis StrepE

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

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/04/043

14.4.2014

10.4.2014

Improvac

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

Zoetis Belgium S.A.

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

EU/2/09/095

14.4.2014

11.4.2014

BTVPUR AlSap 2-4

| Merial |
| --- |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/108

15.4.2014

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 |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK — LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK — LONDON E14 4H

---

(1)  OJ L 136, 30.4.04, p. 1.

(2)  OJ L 136, 30.4.04, p. 1.

---

| 29.5.2014 | EN | Official Journal of the European Union | C 165/9 |
| --- | --- | --- | --- |

29.5.2014

EN

Official Journal of the European Union

C 165/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2014 to 30 April 2014

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

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 28.4.2014 | Ribavirin | ribavirin | Not applicable | Not applicable | 29.4.2014 |
| 28.4.2014 | methysergide | See Annex I | See Annex I | See Annex I | 29.4.2014 |
| 3.4.2014 | 5-aminolevulinic acid | 5-aminolevulinic acid | Not applicable | Not applicable | 7.4.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

28.4.2014

Ribavirin

ribavirin

Not applicable

Not applicable

29.4.2014

28.4.2014

methysergide

See Annex I

See Annex I

See Annex I

29.4.2014

3.4.2014

5-aminolevulinic acid

5-aminolevulinic acid

Not applicable

Not applicable

7.4.2014

---

(1)  OJ L 311, 28.11.01, p. 67.

(2)  OJ L 311, 28.11.01, p. 1.

---

ANNEX I

List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states

| Member State (in EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Amdipharm Ltd |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Member State (in EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Belgium

Amdipharm Ltd

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Deseril

1mg

Coated tablet

Oral use

France

| Amdipharm Ltd |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Ltd

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

DESERNIL

1,65mg

Tablet

Oral use

The Netherlands

| Amdipharm Ltd |
| --- |
| Temple Chambers |
| 3 Burlington Road |
| Dublin 4 |
| Ireland |

Amdipharm Ltd

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Deseril

1mg

Tablet

Oral use

United Kingdom

| Alliance Pharmaceuticals Ltd |
| --- |
| Avonbridge House |
| 2 Bath Road, Chippenham |
| Wiltshire, SN15 2BB |
| United Kingdom |

Alliance Pharmaceuticals Ltd

Avonbridge House

2 Bath Road, Chippenham

Wiltshire, SN15 2BB

United Kingdom

Deseril Tablets 1mg

1mg

Tablet

Oral use

---