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Document 52014XC0328(05)

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2014. do 28. veljače 2014. (Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

SL C 91, 28.3.2014, p. 2–10 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

28.3.2014   

HR

Službeni list Europske unije

C 91/2

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2014. do 28. veljače 2014.

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

2014/C 91/02

—   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

20.2.2014

Izba

travoprost

Alcon Laboratories (UK) Ltd.

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR,

United Kingdom

EU/1/13/905

Kapi za oko, otopina

S01EE04

24.2.2014

20.2.2014

Neuraceq

florbetaben (18F)

Piramal Imaging GmbH

Tegeler Strasse 6-7

13353 Berlin - Deutschland

EU/1/13/906

Otopina za injekciju

V09AX06

24.2.2014

21.2.2014

Mirvaso

brimonidin

Galderma International

Tour Europlaza,

20 avenue André Prothin,

La Défense 4,

La Défense Cedex 92927,

France

EU/1/13/904

Gel

D11AX21

25.2.2014


—   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

6.2.2014

Cystadane

Orphan Europe S.A.R.L.

Immeuble Le Wilson,

70 avenue du Général de Gaulle,

F-92 800 Puteaux,

France

EU/1/06/379

10.2.2014

6.2.2014

Humira

AbbVie Ltd

Maidenhead,

SL6 4XE,

United Kingdom

EU/1/03/256

10.2.2014

6.2.2014

Repso

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/11/674

11.2.2014

6.2.2014

Taxotere

Aventis Pharma S.A.

20 avenue Raymond Aron,

F-92165 Antony CEDEX,

France

EU/1/95/002

10.2.2014

11.2.2014

Pravafenix

LABORATOIRES SMB SA

26-28 rue de la Pastorale / 26-28 Herdersliedstraat,

1080 Brussel/Bruxelles,

Belgique/België

EU/1/11/679

13.2.2014

11.2.2014

Sycrest

Organon N.V.

Kloosterstraat 6,

NL-5349 AB Oss,

Nederland

EU/1/10/640

13.2.2014

11.2.2014

Temozolomide Teva

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/09/606

14.2.2014

12.2.2014

Mozobil

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/09/537

13.2.2014

13.2.2014

Lyrica

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/04/279

17.2.2014

17.2.2014

Conbriza

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/09/511

19.2.2014

17.2.2014

Modigraf

Astellas Pharma Europe B.V.

Sylviusweg 62,

NL-2333 BE Leiden,

Nederland

EU/1/09/523

19.2.2014

17.2.2014

Victrelis

Merck Sharp & Dohme Limited

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/11/704

19.2.2014

20.2.2014

Betmiga

Astellas Pharma Europe B.V.

Sylviusweg 62,

NL-2333 BE Leiden,

Nederland

EU/1/12/809

24.2.2014

20.2.2014

Bosulif

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/13/818

24.2.2014

20.2.2014

Capecitabine Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF,

United Kingdom

EU/1/12/762

22.2.2014

20.2.2014

Capecitabine Teva

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/12/761

25.2.2014

20.2.2014

Constella

Almirall, S.A.

Ronda General Mitre, 151,

E-08022 Barcelona,

España

EU/1/12/801

24.2.2014

20.2.2014

Helixate NexGen

Bayer Pharma AG

D-13342 Berlin,

Deutschland

EU/1/00/144

24.2.2014

20.2.2014

KOGENATE Bayer

Bayer Pharma AG

D-13342 Berlin,

Deutschland

EU/1/00/143

24.2.2014

20.2.2014

Metalyse

Boehringer Ingelheim International GmbH

Binger Straße 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/00/169

24.2.2014

20.2.2014

Mycamine

Astellas Pharma Europe B.V.

Sylviusweg 62,

NL-2333 BE Leiden,

Nederland

EU/1/08/448

24.2.2014

20.2.2014

Nevirapine Teva

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/09/598

25.2.2014

20.2.2014

Zoledronic acid Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78,

220 Hafnarfjörður,

Iceland

EU/1/12/759

24.2.2014

20.2.2014

Zoledronic acid Mylan

Mylan S.A.S

117 allée des Parcs,

F-69800 Saint Priest,

France

EU/1/12/786

24.2.2014

21.2.2014

Celsentri

ViiV Healthcare UK Limited

980 Great West Road,

Brentford,

Middlesex TW8 9GS,

United Kingdom

EU/1/07/418

25.2.2014

21.2.2014

CONTROLOC Control

Takeda GmbH

Byk-Gulden-Straße 2,

D-78467 Konstanz,

Deutschland

EU/1/09/515

25.2.2014

21.2.2014

Fertavid

Merck Sharp & Dohme Limited

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/09/510

25.2.2014

21.2.2014

NeuroBloc

Eisai Limited

European Knowledge Centre,

Mosquito Way, Hatfield,

Hertfordshire AL10 9SN,

United Kingdom

EU/1/00/166

25.2.2014

21.2.2014

NovoThirteen

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/12/775

25.2.2014

21.2.2014

PANTECTA Control

Takeda GmbH

Byk-Gulden-Straße 2,

D-78467 Konstanz,

Deutschland

EU/1/09/518

25.2.2014

21.2.2014

PANTOLOC Control

Takeda GmbH

Byk-Gulden-Straße 2,

D-78467 Konstanz,

Deutschland

EU/1/09/519

25.2.2014

21.2.2014

PANTOZOL Control

Takeda GmbH

Byk-Gulden-Straße 2,

D-78467 Konstanz,

Deutschland

EU/1/09/517

25.2.2014

21.2.2014

SOMAC Control

Takeda GmbH

Byk-Gulden-Straße 2,

D-78467 Konstanz,

Deutschland

EU/1/09/516

25.2.2014

21.2.2014

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/08/494

25.2.2014

21.2.2014

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/09/508

25.2.2014

21.2.2014

Vectibix

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/07/423

25.2.2014

28.2.2014

Adjupanrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/09/578

4.3.2014

28.2.2014

Capecitabine medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6,

D-22880 Wedel,

Deutschland

EU/1/12/802

4.3.2014

28.2.2014

Effentora

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/08/441

5.3.2014

28.2.2014

Instanyl

Takeda Pharma A/S

Langebjerg 1,

DK-4000 Roskilde,

Danmark

EU/1/09/531

4.3.2014

28.2.2014

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3,

A-1030 Wien,

Österreich

EU/1/08/501

4.3.2014

28.2.2014

Menveo

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/614

4.3.2014

28.2.2014

Mirapexin

Boehringer Ingelheim International GmbH

Binger Straße 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/97/051

4.3.2014

28.2.2014

PecFent

Archimedes Development Ltd

Albert Einstein Centre,

Nottingham Science and Technology Park,

University Boulevard NG7 2 TN Nottingham,

United Kingdom

EU/1/10/644

4.3.2014

28.2.2014

Prepandrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/08/453

4.3.2014

28.2.2014

Pumarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/10/664

3.3.2014

28.2.2014

Rebif

Merck Serono Europe Limited

56, Marsh Wall,

London E14 9TP,

United Kingdom

EU/1/98/063

4.3.2014

28.2.2014

Samsca

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs,

Framewood Road,

Wexham, SL3 6PJ,

United Kingdom

EU/1/09/539

4.3.2014

28.2.2014

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/97/050

4.3.2014

28.2.2014

Temozolomide Hospira

Hospira UK Limited

Queensway,

Royal Leamington Spa,

Warwickshire CV31 3RW,

United Kingdom

EU/1/10/615

4.3.2014

28.2.2014

Xolair

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/05/319

4.3.2014


—   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

17.2.2014

Onduarp

Boehringer Ingelheim International GmbH

Binger Straße 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/11/729

19.2.2014


—   Prekid obustave odobrenja za stavljanje u promet (članak 20 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

21.2.2014

Luminity

Lantheus MI UK Limited

Festival House,

39 Oxford Street,

Newbury,

Berkshire RG14 1JG,

United Kingdom

EU/1/06/361

25.2.2014


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

11.2.2014

Bravecto

Fluralaner

Intervet International B.V.

Wim de Körverstraat 35,

NL-5831 AN Boxmeer,

Nederland

EU/2/13/158

Tablete za žvakanje

QP53BX

13.2.2014

11.2.2014

NexGard

afoxolaner

Merial

29 avenue Tony Garnier,

F-69007 Lyon,

France

EU/2/13/159

Tablete za žvakanje

QP53BX04

13.2.2014


—   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

6.2.2014

Melovem

Dopharma Research B.V.

Zalmweg 24,

NL-4941 VX Raamsdonksveer,

Nederland

EU/2/09/098

10.2.2014

10.2.2014

Startvac

Laboratorios Hipra, S.A.

Avda. La Selva, 135,

E-17170- Amer (Girona),

España

EU/2/08/092

12.2.2014

13.2.2014

Contacera

Zoetis Belgium S.A.

Rue Laid Burniat 1,

1348 Louvain-La-Neuve,

Belgique

EU/2/12/144

17.2.2014

13.2.2014

Melosus

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13,

D-31303 Burgdorf,

Deutschland

EU/2/10/116

17.2.2014

20.2.2014

CaniLeish

VIRBAC S.A.

1ère Avenue - 2065 m - L.I.D.,

F-06516 Carros CEDEX,

France

EU/2/11/121

24.2.2014

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

(1)  SL L 136, 30.4.2004, str. 1.

(2)  SL L 136, 30.4.2004, str. 1.

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