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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2013. gada 1. novembra līdz 2013. gada 30. novembrim (publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

OV C 380, 28.12.2013, p. 1–10 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

HTML

PDF

Official Journal

28.12.2013

Eiropas Savienības Oficiālais Vēstnesis

C 380/1

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2013. gada 1. novembra līdz 2013. gada 30. novembrim

(publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004 (1) )

2013/C 380/01

— Tirdzniecības atļaujas izsniegšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

11.11.2013

Levodopa-Carbidopa-Entacapone Sandoz

Levodopa, Carbidopa, Entacapone

Orion Corporation

Orionintie 1,

FI-02200 Espoo,

Suomi

EU/1/13/859

Apvalkotās tabletes

N04BA03

13.11.2013

NovoEight

alfa turoktokoga

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/13/888

Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

B02BD02

15.11.2013

13.11.2013

Relvar Elllipta

flutikazona furoāts/vilanterola trifenatāts

Glaxo Group Ltd

980 Great West Road,

Brentford, Middlesex,

TW8 9GS,

United Kingdom

EU/1/13/886

Inhalācijas pulveris, dalīts

R03AK10

14.11.2013

13.11.2013

Vitekta

elvitegravīrs

Gilead Sciences International Limited

Cambridge

CB21 6GT,

United Kingdom

EU/1/13/883

Apvalkotās tabletes

J05AX11

14.11.2013

13.11.2013

Xofigo

Rādija Ra 223 dihlorīds

Bayer Pharma AG

D-13342 Berlin,

Deutschland

EU/1/13/873

Šķīdums injekcijai

V10XX03

14.11.2013

15.11.2013

ABILIFY MAINTENA

aripiprazole

Otsuka Pharmaceutical Europe Ltd.

Gallions Wexham Springs,

Framewood Road,

Wexham, Slough,

Berkshire SL3 6PJ,

United Kingdom

EU/1/13/882

Pulveris un šķīdinātājs ilgstošās darbības injekciju suspensijas pagatavošanai

N05AX12

19.11.2013

15.11.2013

Invokana

Kanagliflozīns

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/13/884

Apvalkotās tabletes

A10BX11

19.11.2013

15.11.2013

Kadcyla

Trastuzumab emtansine

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/13/885

Pulveris infūziju šķīduma koncentrāta pagatavošanai

L01XC14

19.11.2013

15.11.2013

Lidocaine/Prilocaine Plethora

lidokaīns / prilokaīns

Plethora Solutions Limited

Hampden House,

Monument Business Park,

Chalgrove,

OX44 7RW United Kingdom

EU/1/13/881

Uz ādas izsmidzināms šķīdums

N01BB20

19.11.2013

20.11.2013

Intelence

etravirinum

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/08/468

Tabletes

J05AG04

22.11.2013

— Tirdzniecības atļaujas izsniegšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Noraidītas

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

8.11.2013

Xeljanz

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/13/874

12.11.2013

— Tirdzniecības atļaujas grozīšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

11.11.2013

Edarbi

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London WC2B 4AE,

United Kingdom

EU/1/11/734

12.11.2013

11.11.2013

Ipreziv

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London WC2B 4AE,

United Kingdom

EU/1/11/735

12.11.2013

11.11.2013

Oprymea

Krka, d. d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/08/469

13.11.2013

11.11.2013

Rapamune

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/01/171

13.11.2013

Actos

Takeda Pharma A/S

Langebjerg 1,

DK-4000 Roskilde,

Danmark

EU/1/00/150

15.11.2013

13.11.2013

Competact

Takeda Pharma A/S

PO Box 88,

Langebjerg 1,

DK-4000 Roskilde,

Danmark

EU/1/06/354

14.11.2013

13.11.2013

Efient

Eli Lilly Nederland B.V.

Grootslag 1-5,

NL-3991 RA Houten,

Nederland

EU/1/08/503

15.11.2013

13.11.2013

Enbrel

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/99/126

15.11.2013

13.11.2013

Filgrastim Hexal

Hexal AG

Industriestrasse 25,

D-83607 Holzkirchen,

Deutschland

EU/1/08/496

15.11.2013

13.11.2013

Firmagon

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11,

DK-2300 København S,

Danmark

EU/1/08/504

15.11.2013

13.11.2013

Firmagon

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11,

DK-2300 København S,

Danmark

EU/1/08/504

15.11.2013

13.11.2013

Fycompa

Eisai Europe Limited

European Knowledge Centre,

Mosquito Way,

Hatfield,

Herts AL10 9SN,

United Kingdom

EU/1/12/776

15.11.2013

13.11.2013

Glubrava

Takeda Pharma A/S

Langebjerg 1,

DK-4000 Roskilde,

Danmark

EU/1/07/421

15.11.2013

13.11.2013

Glustin

Takeda Pharma A/S

Langebjerg 1,

DK-4000 Roskilde,

Danmark

EU/1/00/151

15.11.2013

13.11.2013

Invirase

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/96/026

15.11.2013

13.11.2013

Jakavi

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/12/773

15.11.2013

13.11.2013

Kuvan

Merck Serono Europe Limited

56, Marsh Wall,

London E14 9TP,

United Kingdom

EU/1/08/481

15.11.2013

13.11.2013

Ranexa

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare,

L-1611 Luxembourg,

Grand-Duché de Luxembourg

EU/1/08/462

22.11.2013

13.11.2013

Rasilez HCT

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/08/491

15.11.2013

13.11.2013

ReFacto AF

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/99/103

15.11.2013

13.11.2013

Revlimid

Celgene Europe Limited

1 Longwalk Road,

Stockley Park,

Uxbridge,

Middlesex UB11 1DB,

United Kingdom

EU/1/07/391

15.11.2013

13.11.2013

Silodyx

Recordati Ireland Ltd.

Raheens East,

Ringaskiddy Co. Cork,

Ireland

EU/1/09/607

15.11.2013

13.11.2013

Tandemact

Takeda Pharma A/S

Langebjerg 1,

DK-4000 Roskilde,

Danmark

EU/1/06/366

15.11.2013

13.11.2013

Thymanax

Servier (Ireland) Industries Limited

Gorey Road,

Arklow,

Co. Wicklow,

Ireland

EU/1/08/498

15.11.2013

13.11.2013

Thymanax

Servier (Ireland) Industries Limited

Gorey Road,

Arklow,

Co. Wicklow,

Ireland

EU/1/08/498

15.11.2013

13.11.2013

Urorec

Recordati Ireland Ltd.

Raheens East,

Ringaskiddy Co. Cork,

Ireland

EU/1/09/608

15.11.2013

13.11.2013

Valdoxan

Les Laboratoires Servier

50 rue Carnot,

F-92284 Suresnes CEDEX,

France

EU/1/08/499

15.11.2013

13.11.2013

Valdoxan

Les Laboratoires Servier

50 rue Carnot,

F-92284 Suresnes CEDEX,

France

EU/1/08/499

15.11.2013

13.11.2013

Vidaza

Celgene Europe Limited

Riverside House,

Riverside Walk,

Windsor,

Berkshire SL4 1NA,

United Kingdom

EU/1/08/488

15.11.2013

13.11.2013

Zarzio

Sandoz GmbH

Biochemiestrasse 10,

A-6250 Kundl,

Österreich

EU/1/08/495

15.11.2013

Alimta

Eli Lilly Nederland B.V.

Grootslag 1-5,

NL-3991 RA Houten,

Nederland

EU/1/04/290

19.11.2013

15.11.2013

Azilect

Teva Pharma GmbH

Graf-Arco-Straße 3,

D-89079 Ulm,

Deutschland

EU/1/04/304

19.11.2013

15.11.2013

Bretaris Genuair

Almirall, S.A.

Ronda General Mitre, 151,

E-08022 Barcelona,

España

EU/1/12/781

18.11.2013

15.11.2013

Ecansya

Krka, d. d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/12/763

19.11.2013

15.11.2013

Eklira Genuair

Almirall, S.A.

Ronda General Mitre, 151,

E-08022 Barcelona,

España

EU/1/12/778

18.11.2013

15.11.2013

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

Bristol-Myers Squibb House,

Uxbridge Business Park,

Sanderson Road,

Uxbridge,

Middlesex UB8 1DH,

United Kingdom

EU/1/11/691

18.11.2013

15.11.2013

Kineret

Swedish Orphan Biovitrum AB (publ)

SE-112 76,

Stockholm,

Sverige

EU/1/02/203

19.11.2013

15.11.2013

Multaq

Sanofi-Aventis groupe

54 rue La Boétie,

F-75008 Paris,

France

EU/1/09/591

19.11.2013

15.11.2013

Neulasta

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/02/227

19.11.2013

15.11.2013

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/06/380

19.11.2013

15.11.2013

Rapiscan

Rapidscan Pharma Solutions EU Ltd.

Regent's Place,

338 Euston Road,

London NW1 3BT,

United Kingdom

EU/1/10/643

19.11.2013

15.11.2013

Sutent

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/06/347

19.11.2013

15.11.2013

Tygacil

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/06/336

19.11.2013

15.11.2013

Votubia

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/11/710

19.11.2013

20.11.2013

Angiox

The Medicines Company UK Ltd

115 L Milton Park,

Abingdon,

Oxfordshire OX14 4SA,

United Kingdom

EU/1/04/289

22.11.2013

20.11.2013

Beromun

Boehringer Ingelheim International GmbH

Binger Straße 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/99/097

22.11.2013

20.11.2013

Evicel

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15,

B-1831 Diegem,

België

EU/1/08/473

22.11.2013

20.11.2013

Fasturtec

Sanofi-Aventis groupe

54 rue La Boétie,

F-75008 Paris,

France

EU/1/00/170

22.11.2013

20.11.2013

HALAVEN

Eisai Europe Limited

European Knowledge Centre,

Mosquito Way,

Hatfield,

Herts AL10 9SN,

United Kingdom

EU/1/11/678

25.11.2013

20.11.2013

Hycamtin

SmithKline Beecham Ltd.

980 Great West Road,

Brentford,

Middlesex TW8 9GS,

United Kingdom

EU/1/96/027

22.11.2013

20.11.2013

Kalydeco

Vertex Pharmaceuticals (U.K.) Limited

Cardinal Point,

Park Road,

Rickmansworth,

Herts WD3 1RE,

United Kingdom

EU/1/12/782

22.11.2013

20.11.2013

Mabthera

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/98/067

25.11.2013

20.11.2013

Opgenra

Olympus Biotech International Limited

Raheen Business Park,

Limerick,

Ireland

EU/1/08/489

25.11.2013

20.11.2013

Plenadren

ViroPharma SPRL-BVBA

rue Montoyer 47,

1000 Bruxelles,

Belgique / Montoyerstraat 47,

1000 Brussel,

België

EU/1/11/715

21.11.2013

20.11.2013

Prevenar 13

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/09/590

22.11.2013

20.11.2013

Rotarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/05/330

22.11.2013

20.11.2013

Telzir

ViiV Healthcare UK Limited

980 Great West Road,

Brentford,

Middlesex TW8 9GS,

United Kingdom

EU/1/04/282

22.11.2013

20.11.2013

Torisel

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/07/424

22.11.2013

20.11.2013

Zoledronic acid Teva Pharma

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/12/772

22.11.2013

25.11.2013

Cimzia

UCB Pharma S.A.

Allée de la Recherche 60,

1070 Bruxelles,

Belgique/Researchdreef 60,

1070 Brussel,

België

EU/1/09/544

27.11.2013

25.11.2013

Elaprase

Shire Human Genetic Therapies AB

Svärdvägen 11D,

SE-182 33 Danderyd,

Sverige

EU/1/06/365

27.11.2013

25.11.2013

GILENYA

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/11/677

27.11.2013

25.11.2013

Pandemic influenza vaccine H5N1 BAXTER

Baxter AG

Industriestraße 67,

A-1221 Wien,

Österreich

EU/1/09/571

27.11.2013

25.11.2013

Reyataz

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park,

Sanderson Road,

Uxbridge UB8 1DH,

United Kingdom

EU/1/03/267

27.11.2013

25.11.2013

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/09/508

27.11.2013

25.11.2013

Vepacel

Baxter Innovations GmbH

Industriestraße 67,

A-1221 Wien,

Österreich

EU/1/12/752

27.11.2013

28.11.2013

Jalra

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/08/485

29.11.2013

28.11.2013

Xiliarx

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/08/486

29.11.2013

Arixtra

Glaxo Group Ltd

980 Great West Road,

Brentford, Middlesex,

TW8 9GS,

United Kingdom

EU/1/02/206

2.12.2013

29.11.2013

Busilvex

Pierre Fabre Médicament

45 place Abel Gance,

F-92654 Boulogne-Billancourt CEDEX,

France

EU/1/03/254

3.12.2013

29.11.2013

Eviplera

Gilead Sciences International Limited

Cambridge CB21 6GT,

United Kingdom

EU/1/11/737

4.12.2013

29.11.2013

Preotact

NPS Pharma Holdings Limited

Grand Canal House,

1 Grand Canal Street Upper,

Dublin 4,

Ireland

EU/1/06/339

3.12.2013

29.11.2013

Prevenar

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/00/167

3.12.2013

29.11.2013

Xeloda

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/00/163

3.12.2013

— Tirdzniecības atļaujas grozīšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

8.11.2013

Onsior

Novartis Animal Health UK Ltd

Frimley Business Park,

Frimley/Camberley,

Surrey,

GU16 7SR,

United Kingdom

EU/2/08/089

13.11.2013

8.11.2013

Zulvac 1+8 Bovis

Zoetis Belgium S.A.

Rue Laid Burniat 1,

1348 Louvain-La-Neuve,

Belgique

EU/2/12/139

13.11.2013

11.11.2013

Easotic

VIRBAC S.A.

1ère Avenue - 2065 m - L.I.D.,

F-06516 Carros CEDEX,

France

EU/2/08/085

13.11.2013

Comfortis

Eli Lilly and Company Ltd

Priestley Road,

Basingstoke,

Hampshire RG24 9NL,

United Kingdom

EU/2/10/115

15.11.2013

20.11.2013

CERTIFECT

Merial

29 avenue Tony Garnier,

F-69007 Lyon,

France

EU/2/11/125

22.11.2013

Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK - LONDON E14 4H

(1) OV L 136, 30.4.2004, 1. lpp.

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