# Službeni list C 199/27.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 199 |
| | |
| Hrvatsko izdanje | Informacije i objave | Svezak 57.27. lipnja 2014. |

ISSN 1977-1088

Službeni list

Europske unije

C 199

Hrvatsko izdanje

Informacije i objave

Svezak 57.27. lipnja 2014.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2014/C 199/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. svibnja 2014. do 31. svibnja 2014.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2014/C 199/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. svibnja 2014. do 31. svibnja 2014.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

1

| HR | |
| --- | --- |

HR

---

IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 27.6.2014 | HR | Službeni list Europske unije | C 199/1 |
| --- | --- | --- | --- |

27.6.2014

HR

Službeni list Europske unije

C 199/1

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. svibnja 2014. do 31. svibnja 2014.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))

2014/C 199/01

—   Izdavanje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.5.2014. | Revinty Ellipta | flutikazonfuroat/vilanterol | Glaxo Group Ltd |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

2.5.2014.

Revinty Ellipta

flutikazonfuroat/vilanterol

Glaxo Group Ltd

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

EU/1/14/929

Prašak inhalata, dozirani

R03AK10

6.5.2014.

8.5.2014.

Anoro

umeclidinium bromide/vilanterol trifenatate

| 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/1/14/898

Prašak inhalata, dozirani

R03AL03

13.5.2014.

8.5.2014.

Laventair

umeclidinium bromide/vilanterol trifenatate

| 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/1/14/899

Prašak inhalata, dozirani

R03AL03

13.5.2014.

14.5.2014.

OLYSIO

simeprevir

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/924

Kapsula, tvrda

J05AE14

16.5.2014.

22.5.2014.

Ebilfumin

oseltamivir

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

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/14/915

Kapsula, tvrda

J05AH02

27.5.2014.

22.5.2014.

Entyvio

Vedolizumab

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

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/923

Prašak za koncentrat za otopinu za infuziju

L04AA33

27.5.2014.

22.5.2014.

Jardiance

Empagliflozin

| 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/1/14/930

Filmom obložena tableta

A10BX12

27.5.2014.

22.5.2014.

Sylvant

siltuksimab

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/928

Prašak za koncentrat za otopinu za infuziju

Pending

27.5.2014.

—   Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 2.5.2014. | Invirase | Roche Registration Limited |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

2.5.2014.

Invirase

Roche Registration Limited

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

EU/1/96/026

6.5.2014.

6.5.2014.

NutropinAq

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France |

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/00/164

9.5.2014.

6.5.2014.

Rivastigmine 1 A Pharma

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3, D-82041 Oberhaching, Deutschland |

1 A Pharma GmbH

Keltenring 1 + 3, D-82041 Oberhaching, Deutschland

EU/1/09/585

8.5.2014.

6.5.2014.

Vyndaqel

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

Pfizer Limited

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

EU/1/11/717

8.5.2014.

7.5.2014.

Tresiba

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/807

9.5.2014.

7.5.2014.

Trobalt

| 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/1/11/681

9.5.2014.

8.5.2014.

Clopidogrel Teva Pharma

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

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/561

14.5.2014.

8.5.2014.

Zylagren

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

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/558

13.5.2014.

14.5.2014.

Clopidogrel Krka

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

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556

16.5.2014.

14.5.2014.

InductOs

| Medtronic BioPharma B.V. |
| --- |
| Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland |

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland

EU/1/02/226

16.5.2014.

14.5.2014.

Isentress

| 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/1/07/436

16.5.2014.

14.5.2014.

Pandemic influenza vaccine H5N1 BAXTER

| Baxter AG |
| --- |
| Industriestraße 67, A-1221 Wien, Österreich |

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

EU/1/09/571

16.5.2014.

14.5.2014.

XALKORI

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

Pfizer Limited

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

EU/1/12/793

16.5.2014.

14.5.2014.

Zyllt

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

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/553

16.5.2014.

16.5.2014.

Afinitor

| 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/1/09/538

20.5.2014.

16.5.2014.

Cimzia

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/09/544

20.5.2014.

16.5.2014.

Clopidogrel Teva

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

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/540

20.5.2014.

16.5.2014.

Clopidogrel Teva Pharma B.V.

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

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/10/649

20.5.2014.

16.5.2014.

Docetaxel Accord

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

Accord Healthcare Limited

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

EU/1/12/769

20.5.2014.

16.5.2014.

Javlor

| Pierre Fabre Médicament |
| --- |
| 45, place Abel Gance, F-92100 Boulogne, France |

Pierre Fabre Médicament

45, place Abel Gance, F-92100 Boulogne, France

EU/1/09/550

20.5.2014.

16.5.2014.

Vizarsin

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

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/551

20.5.2014.

22.5.2014.

Adjupanrix

| 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/1/09/578

27.5.2014.

22.5.2014.

Busilvex

| Pierre Fabre Médicament |
| --- |
| 45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France |

Pierre Fabre Médicament

45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France

EU/1/03/254

27.5.2014.

22.5.2014.

Clopidogrel DURA

| Mylan dura GmbH |
| --- |
| Wittichstraße 6, D-64295 Darmstadt, Deutschland |

Mylan dura GmbH

Wittichstraße 6, D-64295 Darmstadt, Deutschland

EU/1/09/560

27.5.2014.

22.5.2014.

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

27.5.2014.

22.5.2014.

Clopidogrel ratiopharm GmbH

| Archie Samuel s.r.o. |
| --- |
| Slunná 16, CZ-61700 Brno, Česká republika |

Archie Samuel s.r.o.

Slunná 16, CZ-61700 Brno, Česká republika

EU/1/09/541

27.5.2014.

22.5.2014.

Clopidogrel TAD

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland |

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland

EU/1/09/555

27.5.2014.

22.5.2014.

Docetaxel Kabi

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

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom

EU/1/12/770

27.5.2014.

22.5.2014.

Fampyra

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

Biogen Idec Limited

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

EU/1/11/699

27.5.2014.

22.5.2014.

Grastofil

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

Apotex Europe B.V.

Darwinweg 20, NL- 2333 CR Leiden, Nederland

EU/1/13/877

27.5.2014.

22.5.2014.

Iasibon

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

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/10/659

27.5.2014.

22.5.2014.

Ipreziv

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

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/11/735

27.5.2014.

22.5.2014.

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

27.5.2014.

22.5.2014.

PegIntron

| 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/1/00/131

27.5.2014.

22.5.2014.

Prepandrix

| 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/1/08/453

27.5.2014.

22.5.2014.

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

27.5.2014.

22.5.2014.

Selincro

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

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/12/815

27.5.2014.

22.5.2014.

Vaniqa

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

Almirall, S.A.

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

EU/1/01/173

27.5.2014.

22.5.2014.

ViraferonPeg

| 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/1/00/132

27.5.2014.

23.5.2014.

Clopidogrel Acino

| Acino AG |
| --- |
| Am Windfeld 35, 83714 Miesbach, Deutschland |

Acino AG

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/532

27.5.2014.

23.5.2014.

GILENYA

| 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/1/11/677

27.5.2014.

23.5.2014.

Invega

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/07/395

27.5.2014.

23.5.2014.

Mabthera

| 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/1/98/067

27.5.2014.

23.5.2014.

Nexavar

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/06/342

27.5.2014.

23.5.2014.

Suboxone

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

RB Pharmaceuticals Limited

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

EU/1/06/359

27.5.2014.

—   Povlačenje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 16.5.2014. | Preotact | NPS Pharma Holdings Limited |
| Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

16.5.2014.

Preotact

NPS Pharma Holdings Limited

Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland

EU/1/06/339

20.5.2014.

—   Izdavanje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (2)): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.5.2014. | Versican Plus DHPPi/L4 | Versican Plus DHPPi/L4 | Zoetis Belgium S.A. |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

7.5.2014.

Versican Plus DHPPi/L4

Versican Plus DHPPi/L4

Zoetis Belgium S.A.

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

EU/2/14/164

Liofilizat i otapalo, suspenzija za injekciju

QI07AI02

9.5.2014.

7.5.2014.

Versican Plus DHPPi/L4R

Versican Plus DHPPi/L4R

| 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/2/14/163

Liofilizat i otapalo, suspenzija za injekciju

QI07AJ06

9.5.2014.

—   Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 7.5.2014. | Recocam | Cross Vetpharm Group, Ltd |
| Broomhill Road, Tallaght Dublin 24, Ireland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

7.5.2014.

Recocam

Cross Vetpharm Group, Ltd

Broomhill Road, Tallaght Dublin 24, Ireland

EU/2/11/133

8.5.2014.

16.5.2014.

Circovac

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

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/07/075

20.5.2014.

—   Povlačenje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 6.5.2014. | Flexicam | Dechra Veterinary Products A/S |
| Mekuvej 9, DK-7171 Uldum, Danmark |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

6.5.2014.

Flexicam

Dechra Veterinary Products A/S

Mekuvej 9, DK-7171 Uldum, Danmark

EU/2/06/058

8.5.2014.

Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:

| 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

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(1)  SL L 136, 30.4.2004, str. 1.

(2)  SL L 136, 30.4.2004, str. 1.

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