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Document 52004XC0827(02)

Bendrijos sprendimų dėl leidimų prekiauti vaistais sąrašas nuo 2004 4 15 iki 2004 5 15 (paskelbta sutinkamai su Tarybos Reglamento (EEB) Nr. 2309/93 12 arba 34 straipsniu)

OL C 215, 2004 8 27, p. 7–10 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)

27.8.2004   

LT

Europos Sąjungos oficialusis leidinys

C 215/7


Bendrijos sprendimų dėl leidimų prekiauti vaistais sąrašas nuo 2004 4 15 iki 2004 5 15

(paskelbta sutinkamai su Tarybos Reglamento (EEB) Nr. 2309/93 (1) 12 arba 34 straipsniu)

(2004/C 215/05)

Leidimo prekiauti išdavimas (Tarybos Reglamento (EEB) Nr. 2309/93 (1) 12 straipsnis), leidimas išduotas

Sprendimo data

Vaisto pavadinimas

Leidimo savininkas

Įrašo Bendrijos registre nr.

Pranešimo data

2004 7 29

Pedea

Orphan Europe, Immeuble „Le Guillaumet“, F-92046 Paris La Défense, France

EU/1/04/284/001

2004 8 2

2004 8 11

Yentreve

Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/280/001-006.

2004 8 13

2004 8 11

Ariclaim

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

EU/1/04/283/001-006

2004 8 13

Leidimo prekiauti pakeitimas (Tarybos Reglamento (EEB) Nr. 2309/93 (1) 12 straipsnis), leidimas pakeistas

Sprendimo data

Vaisto pavadinimas

Leidimo savininkas

Įrašo Bendrijos registre nr.

Pranešimo data

2004 7 19

Reyataz

Bristol - Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom

EU/1/03/267/001-007

2004 7 21

2004 7 19

Humira

Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom

EU/1/03/256/001-006

2004 7 21

2004 7 19

Trudexa

Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom

EU/1/03/257/001-006

2004 7 21

2004 7 19

Nyracta

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

EU/1/00/139/001-012

2004 7 21

2004 7 19

Avandia

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

EU/1/00/137/001-012

2004 7 21

2004 7 19

Venvia

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

EU/1/00/138/001-012

2004 7 21

2004 7 20

Rebif

Serono Europe Ltd., 56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/98/063/001-006

2004 7 23

2004 7 20

Replagal

TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige

EU/1/01/189/001-003

2004 7 23

2004 7 20

Refacto

Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/103/001-004

2004 7 23

2004 7 22

Mirapexin

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

Pfizer Enterprises SARL, 6, Circuit de la Foire Internationale, 1347 Luxembourg, Grand-Duché du Luxembourg

EU/1/97/051/001-006 EU/1/97/051/009-012

2004 7 26

2004 7 23

Enbrel

Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/126/001-003

2004 7 27

2004 7 23

Enbrel

Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/126/001-003

2004 7 27

2004 7 29

ReFacto

Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/103/001-004

2004 8 2

2004 7 29

Replagal

TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige

EU/1/01/189/004-006

2004 8 2

2004 8 2

Procomvax

Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France

EU/1/99/104/001

2004 8 4

2004 8 2

CoAprovel

Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France

EU/1/98/086/001-020

2004 8 4

2004 8 2

Aprovel

Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France

EU/1/97/046/001-030

2004 8 4

2004 8 2

Karvezide

Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom

EU/1/98/085/001-020

2004 8 4

2004 8 2

Karvea

Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom

EU/1/97/049/001-030

2004 8 4

2004 8 2

MabThera

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/98/067/001-002

2004 8 4

2004 8 2

Plavix

Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France

EU/1/98/069/001a-001b, EU/1/98/069/002a-002b, EU/1/98/069/003a-003b, EU/1/98/069/004a-004b

2004 8 4

2004 8 2

Iscover

Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom

EU/1/98/070/001a-001b, EU/1/98/070/002a-002b, EU/1/98/070/003a-003b, EU/1/98/070/004a-004b

2004 8 4

2004 8 2

Prevenar

Wyeth-Lederle Vaccines S.A., Rue du Bosquet, 15 - 1348 Louvain-La-Neuve - Belgique

EU/1/00/167/001-007

2004 8 4

2004 8 2

Actrapid

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

EU/1/02/230/001-017

2004 8 4

2004 8 2

Mixtard

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

EU/1/02/231/001-037

2004 8 4

2004 8 2

Insulatard

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

EU/1/02/233/001-017

2004 8 4

2004 8 2

Velosulin

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

EU/1/02/232/001-003

2004 8 4

2004 8 2

Protaphane

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

EU/1/02/234/001-017

2004 8 4

2004 8 2

Puregon

Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland

EU/1/96/008/040-041

2004 8 4

2004 8 2

Puregon

Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland

EU/1/96/008/001-039

2004 8 4

2004 8 2

Viread

Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom

EU/1/01/200/001

2004 8 4

2004 8 2

Emtriva

Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom

EU/1/03/261/001-003

2004 8 4

2004 8 2

Actraphane

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

EU/1/02/229/001-037

2004 8 4

2004 8 2

Norvir

Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United-Kingdom

EU/1/96/016/001 and EU/1/96/016/003

2004 8 4

2004 8 2

Starlix

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

EU/1/01/174/001-021

2004 8 4

2004 8 2

Cellcept

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/96/005/001-006

2004 8 4

2004 8 2

Protopy

Fujisawa GmbH, Neumarkter Str. 61, D-81673 München, Deutschland

EU/1/02/202/001-007

2004 8 4

2004 8 2

Inomax

INO Therapeutics AB, SE-181 81 Lidingö, Sverige

EU/1/01/194/001-002

2004 8 4

2004 8 2

Trazec

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

EU/1/01/175/001-021

2004 8 4

2004 8 4

Insuman

Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, Deutschland

EU/1/97/030/030, EU/1/97/030/035, EU/1/97/030/040, EU/1/97/030/045, EU/1/97/030/050, EU/1/97/030/055-064

2004 8 6

2004 8 4

Somavert

Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/02/240/001-004

2004 8 6

2004 8 9

Fabrazyme

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

EU/1/01/188/001-006

2004 8 12

2004 8 11

Vfend

Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/02/212/001-026

2004 8 13

2004 8 12

Infergen

Yamanouchi Europe B.V., Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland

EU/1/98/087/001-003

2004 8 16

2004 8 12

Optison

Amersham Health AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, 0401 Oslo, Norway

EU/1/98/065/001-002

2004 8 16

Leidimo prekiauti pakeitimas (Tarybos Reglamento (EEB) Nr. 2309/93 (1) 34 straipsnis), leidimas pakeistas

Sprendimo data

Vaisto pavadinimas

Leidimo savininkas

Įrašo Bendrijos registre nr.

Pranešimo data

2004 7 23

Eurifel RCP FeL V

Merial, 29 avenue Tony Garnier, 69007 Lyon, France

EU/2/02/031/001-002

2004 7 27

2004 7 29

Virbagen Omega

VIRBAC S.A., 1ere Avenue 2065 m L.I.D. - 06516 Carros - France

EU/2/01/030/001-002

2004 8 2

2004 8 11

Porcilis Porcoli

Intervet International B.V. (NL), Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/96/001/009-010

2004 8 13

Pageidaujantys susipažinti su konkretaus vaisto viešo įvertinimo ataskaita ir su sprendimu dėl jo gali kreiptis į Europos vaistų vertinimo agentūrą:

The European Agency for the Evaluation of Medicinal products

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4HB


(1)  OL L 214 1993 m. rugpjūčio 24 d., 1 puslapis.


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