28.9.2007   

LT

Europos Sąjungos oficialusis leidinys

C 228/2

Bendrijos sprendimų dėl leidimų prekiauti vaistais sąrašas nuo 2007 m. rugpjūčio 1 d. iki 2007 m. rugpjūčio 31 d.

(Paskelbtas pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004  (1) 13 arba 38 straipsnį)

(2007/C 228/02)

—   Leidimas prekiauti (pagal reglamento (EB) Nr. 726/2004 13 straipsnį): išduotas

Sprendimo data

Vaisto pavadinimas

INN

(Tarptautinis nepatentuotas pavadinimas)

Leidimo prekiauti turėtojas

Įrašo Bendrijos registre numeris

Vaisto forma

ATC kodas

(Anatominis terapinis cheminis kodas)

Pranešimo data

2007 8 3

INCRELEX

Mekaserminas

Tercica Europe Limited

2 Harbourmaster Place

International Financial Services Centre

Dublin 1

Ireland

EU/1/07/402/001

Injekcinis tirpalas

H01AC03

2007 8 7

2007 8 22

Enviage

aliskirenas

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/406/001-020

Plėvele dengta tabletė

C09XA02

2007 8 24

2007 8 22

Riprazo

aliskirenas

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/409/001-020

Plėvele dengta tabletė

C09XA02

2007 8 24

2007 8 22

Sprimeo

aliskirenas

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/407/001-020

Plėvele dengta tabletė

C09XA02

2007 8 24

2007 8 22

Rasilez

aliskirenas

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/405/001-020

Plėvele dengta tabletė

C09XA02

2007 8 24

2007 8 22

Tekturna

aliskirenas

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/408/001-020

Plėvele dengta tabletė

C09XA02

2007 8 24

2007 8 22

Atriance

nelarabinas

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/07/403/001

Infuzinis tirpalas

L01BB07

2007 8 24

2007 8 23

Flebogammadif

Žmogaus normalusis imunoglobulinas

Instituto Grifols S.A.

Can Guasch

2 — Parets del Vallès

E-08150 Barcelona

EU/1/07/404/001-005

Infuzinis tirpalas

J06BA02

2007 8 27

2007 8 28

Abseamed

epoetinas alfa

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

D-58638 Iserlohn

EU/1/07/412/001-016

Injekcinis tirpalas užpildytame švirkšte

B03XA01

2007 8 31

2007 8 28

Binocrit

epoetinas alfa

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

EU/1/07/410/001-016

Injekcinis tirpalas užpildytame švirkšte

B03XA01

2007 8 31

2007 8 28

Epoetin alfa hexal

epoetinas alfa

HEXAL Biotech Forschungs GmbH

Industriestrasse 25

D-83607 Holzkirchen

EU/1/07/411/001-016

Injekcinis tirpalas užpildytame švirkšte

B03XA01

2007 9 3

—   Leidimas prekiauti (pagal Reglamento (EB) Nr. 726/2004 13 straipsnį): pakeistas

Sprendimo data

Vaisto pavadinimas

Leidimo prekiauti turėtojas

Įrašo Bendrijos registre numeris

Pranešimo data

2007 8 1

Keppra

UCB S.A.

Allée de la Recherche, 60

B-1070 Bruxelles

Researchdreef, 60

B-1070 Brussel

UCB Pharma SA.

Allée de la Recherche 60

B-1070 Bruxelles

Researchdreef, 60

B-1070 Brussel

EU/1/00/146/001-030

2007 8 3

2007 8 3

TachoSil

Nycomed Austria GMBH

St.-Peter-Straße 25

A-4020 Linz

EU/1/04/277/001-004

2007 8 7

2007 8 7

BeneFIX

Wyeth Europa Ltd

Huntercombe Lane South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/97/047/001-007

2007 8 9

2007 8 10

Norvir

Abbott laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/96/016/001

EU/1/96/016/003-004

2007 8 14

2007 8 10

Fasturtec

Sanofi-Aventis

174, avenue de France

F-75013 Paris

EU/1/00/170/001-002

2007 8 14

2007 8 10

Ceprotin

Baxter AG

Industriestraße 67

A-1220 Vienna

EU/1/01/190/001-002

2007 8 14

2007 8 10

Cellcept

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/96/005/001-006

2007 8 14

2007 8 10

Rebif

Serono Europe Limited

56, Marsh Wall

London E14 9TP

United Kingdom

EU/1/98/063/001-007

2007 8 14

2007 8 10

Tritanrix HepB

GlaxoSmithKline Biologicals S.A.

rue de l'Institut, 89

B-1330 Rixensart

EU/1/96/014/001-003

2007 8 14

2007 8 10

Cialis

Lilly ICOS Limited

St Bride's House

10 Salisbury Square

London EC4Y 8EH

United Kingdom

EU/1/02/237/001-008

2007 8 22

2007 8 20

Actos

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/00/150/001-024

2007 8 22

2007 8 20

Glustin

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/00/151/001-022

2007 8 22

2007 8 20

Competact

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/06/354/001-009

2007 8 22

2007 8 21

Forsteo

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/03/247/001-002

2007 8 23

2007 8 21

Nexavar

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/06/342/001

2007 8 23

2007 8 21

Opatanol

Alcon Laboratories (UK) Ltd

Pentagon Park

Boundary Way

Hemel Hempstead

Herts HP2 7UD

United Kingdom

EU/1/02/217/001-002

2007 8 23

2007 8 21

NeuroBloc

Solstice Neurosciences Ltd

Fitzwilton House

Wilton Place

Dublin 2

Ireland

EU/1/00/166/001-003

2007 8 23

2007 8 21

Avastin

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/04/300/001-002

2007 8 23

2007 8 21

Kiovig

Baxter AG

Industriestraße 67

A-1220 Vienna

EU/1/05/329/001-005

2007 8 23

2007 8 22

Sprycel

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/06/363/001-009

2007 8 24

2007 8 22

Luminity

Bristol-Myers Squibb Pharma Belgium Sprl

Chaussée de la Hulpe, 185

B-1170 Brussel

EU/1/06/361/001-002

2007 8 24

2007 8 22

Emtriva

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/03/261/001-003

2007 8 24

2007 8 22

Baraclude

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/06/343/001-005

2007 8 24

2007 8 23

Inovelon

Eisai Limited, 3

Shortlands

London W6 8EE

United Kingdom

EU/1/06/378/001-016

2007 8 28

2007 8 23

Stocrin

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/99/111/001-011

2007 8 28

2007 8 23

Sustiva

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/99/110/001-009

2007 8 28

2007 8 23

Orfadin

Swedish Orphan International AB

Drottninggatan 98

S-111 60 Stockholm

EU/1/04/303/001-003

2007 8 27

2007 8 27

Kivexa

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/298/001-002

2007 8 29

2007 8 27

Ziagen

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/99/112/001-002

2007 8 29

2007 8 27

Rapamune

Wyeth Europa Limited

Huntercombe Lane South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/01/171/001

EU/1/01/171/007-012

2007 8 29

2007 8 27

Prezista

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/06/380/001

2007 8 29

2007 8 27

NovoMix

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/00/142/004-005

EU/1/00/142/009-022

2007 8 29

2007 8 27

Invanz

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/02/216/001-002

2007 8 29

2007 8 27

Tandemact

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/06/366/001-004

2007 8 29

2007 8 27

Ebixa

H. Lundbeck A/S

Ottiliavej 9

DK-2500 Valby

EU/1/02/219/001-015

2007 8 29

2007 8 29

Enbrel

Wyeth Europa Limited

Huntercombe Lane South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/99/126/001-018

2007 8 31

2007 8 28

Cymbalta

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/296/001-009

2007 8 31

2007 8 28

Xeristar

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/04/297/001-008

2007 8 31

2007 8 28

YENTREVE

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/280/001-008

2007 8 31

2007 8 28

Ariclaim

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/04/283/001-007

2007 8 31

2007 8 29

Stalevo

Orion Corporation

Orionintie 1

FIN-02200 Espoo

EU/1/03/260/001-018

2007 8 31

2007 8 29

Exubera

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/05/327/001-018

2007 8 31

2007 8 29

Vistide

Pfizer Enterprises SARL

51, Avenue Kennedy

Rond Point du Kirchberg

L-1855 Luxembourg

EU/1/97/037/001

2007 8 31

2007 8 29

Evoltra

Bioenvision Limited

Bassett House

5 Southwell Park Road

Camberley

Surrey GU15 3PU

United Kingdom

EU/1/06/334/001-004

2007 8 31

2007 8 29

Xelevia

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/07/382/001-018

2007 8 31

2007 8 29

Januvia

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

EU/1/07/383/001-018

2007 8 31

2007 8 29

Quixidar

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/207/001-004

2007 8 31

2007 8 29

Quixidar

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/207/001-004

2007 8 31

2007 8 29

Arixtra

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/206/001-004

2007 8 31

2007 8 29

Arixtra

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/206/001-004

2007 8 31

2007 8 30

Fuzeon

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/03/252/001-003

2007 9 5

2007 8 30

BYETTA

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/06/362/001-004

2007 9 5

2007 8 30

Agenerase

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/148/001-004

2007 9 5

2007 8 30

Aranesp

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/01/185/001-073

2007 9 5

2007 8 30

NovoRapid

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/99/119/001

EU/1/99/119/003

EU/1/99/119/005-014

2007 9 5

2007 8 30

Nespo

Dompé Biotec S.p.A.

Via San Martino 12

I-20122 Milano

EU/1/01/184/001-073

2007 9 5

2007 8 30

Zyprexa

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/96/022/002

EU/1/96/022/004

EU/1/96/022/006

EU/1/96/022/008-012

EU/1/96/022/014

EU/1/96/022/016-017

EU/1/96/022/019-034

2007 9 5

2007 8 30

Zyprexa Velotab

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/99/125/001-016

2007 9 5

2007 8 30

InductOs

Wyeth Europa Ltd

Huntercombe Lane South Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/02/226/001

2007 9 5

2007 8 30

Aldara

Laboratoires 3M Santé

Boulevard de l'Oise

F-95029 Cergy Pontoise Cedex

EU/1/98/080/001

2007 9 5

Meda AB

Pipers väg 2A

S-170 73 Solna

2007 9 5

2007 8 31

Karvea

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/97/049/001-039

2007 9 6

2007 8 31

Aprovel

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France

F-75013 Paris

EU/1/97/046/001-039

2007 9 5

2007 8 31

CUBICIN

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/05/328/001-002

2007 9 5

2007 8 31

Glustin

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/00/151/001-024

2007 9 5

2007 8 31

Mimpara

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/04/292/001-012

2007 9 6

2007 8 31

Parareg

Dompé Biotec S.p.A.

Via San Martino 12

I-20122 Milano

EU/1/04/293/001-012

2007 9 6

2007 8 31

Epivir

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/96/015/001-005

2007 9 6

2007 8 31

Zimulti

Sanofi-Aventis

174, avenue de France

F-75013 Paris

EU/1/06/345/001-011

2007 9 6

2007 8 31

ACOMPLIA

Sanofi-Aventis

174, avenue de France

F-75013 Paris

EU/1/06/344/001-011

2007 9 6

2007 8 31

Prevenar

Wyeth-Lederle Vaccines S.A.

Rue du Bosquet

B-15-1348 Louvain-La-Neuve

EU/1/00/167/001-007

2007 9 6

—   Leidimas prekiauti (pagal Reglamento (EB) Nr. 726/2004 20 straipsnį): sustabdytas

Sprendimo data

Vaisto pavadinimas

Leidimo prekiauti turėtojas

Įrašo Bendrijos registre numeris

Pranešimo data

2007 8 6

Viracept

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/97/054/001

EU/1/97/054/003-005

2007 8 8

—   Leidimas prekiauti (pagal reglamento (EB) Nr. 726/2004 38 straipsnį): pakeistas

Sprendimo data

Vaisto pavadinimas

Leidimo prekiauti turėtojas

Įrašo Bendrijos registre numeris

Pranešimo data

2007 8 2

Dexdomitor

Orion Corporation

Orionintie 1

FIN-02200 Espoo

EU/2/02/033/001

2007 8 6

2007 8 13

Advocate

Bayer HealthCare AG

D-51368 Leverkusen

EU/2/03/039/001-030

2007 8 15

2007 8 23

PRAC-TIC

Novartis Sanidad Animal S.L.

Calle de la Marina, 206

E-08013 Barcelona

EU/2/06/066/001-012

2007 8 27

2007 8 27

Yarvitan

Janssen Animal Health B.V.B.A.

Turnhoutseweg, 30

B-2340 Beerse

EU/2/06/063/001-003

2007 8 29

Janssen Pharmaceutica N.V.

Turnhoutseweg, 30

B-2340 Beerse

2007 8 29

Pageidaujantys susipažinti su konkrečių vaistų viešo įvertinimo ataskaita ir su sprendimais dėl jų gali kreiptis į Europos vaistų agentūrą:

The European Medicines Agency

7, Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

(1)  OL L 136, 2004 4 30, p. 1.