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Document 52007XC0427(02)

    Kopsavilkums par Kopienas lēmumiem attiecībā uz zāļu tirdzniecības atļaujām no 1.3.2007 . līdz 31.3.2007 . (Publicēts atbilstīgi 13. pantam vai 38. pantam Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004

    OV C 92, 27.4.2007, p. 15–21 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, RO, SK, SL, FI, SV)

    27.4.2007   

    LV

    Eiropas Savienības Oficiālais Vēstnesis

    C 92/15

    Kopsavilkums par Kopienas lēmumiem attiecībā uz zāļu tirdzniecības atļaujām no 1.3.2007. līdz 31.3.2007.

    (Publicēts atbilstīgi 13. pantam vai 38. pantam Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004 (1)

    (2007/C 92/15)

    —   Tirdzniecības atļaujas izsniegšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) No726/2004): Pieņemts

    Lēmuma datums

    Zāļu nosaukums

    SNN

    (Starptautiskais nepatentētais nosaukums)

    Tirdzniecības atļaujas turētājs

    Ieraksta numurs Kopienas reģistrā

    Farmaceitiskā forma

    ATĶ kods

    (Anatomiski terapeitiski ķīmiskais kods)

    Paziņojuma datums

    21.3.2007.

    Daronrix

    A/Viet Nam/1194/2004 (H5N1) vesela vīrusa inaktivēts antigēns

    GlaxoSmithKline Biologicals s.a.

    rue de l'Institut 89

    B-1330 Rixensart

    EU/1/06/381/001-008

    Suspensija injekcijām

    J07BB01

    23.3.2007.

    21.3.2007.

    Xelevia

    sitagliptīns

    Merck Sharp & Dohme Ltd

    Hertford Road

    Hoddesdon

    Hertfordshire EN11 9BU

    United Kingdom

    EU/1/07/382/001-018

    Apvalkotās tabletes

    A10BH01

    23.3.2007.

    21.3.2007.

    Januvia

    sitagliptīns

    Merck Sharp & Dohme Ltd

    Hertford Road

    Hoddesdon

    Hertfordshire EN11 9BU

    United Kingdom

    EU/1/07/383/001-018

    Apvalkotās tabletes

    A10BH01

    23.3.2007.

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

    Lēmuma datums

    Zāļu nosaukums

    Tirdzniecības atļaujas turētājs

    Ieraksta numurs Kopienas reģistrā

    Paziņojuma datums

    1.3.2007.

    Kinzalmono

    Bayer HealthCare AG

    D-51368 Leverkusen

    EU/1/98/091/001-014

    5.3.2007.

    1.3.2007.

    Epivir

    Glaxo Group Ltd, Greenford Road

    Greenford

    Middlesex UB6 0NN

    United Kingdom

    EU/1/96/015/001-005

    5.3.2007.

    1.3.2007.

    Xyrem

    UCB Pharma Ltd

    208 Bath Road

    Slough

    Berks SL1 3WE

    United Kingdom

    EU/1/05/312/001

    5.3.2007.

    1.3.2007.

    Integrilin

    Glaxo Group Ltd

    Berkeley Avenue

    Greenford

    Middlesex UB6 0NN

    United Kingdom

    EU/1/99/109/001-002

    5.3.2007.

    1.3.2007.

    PEGASYS

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/02/221/001-010

    5.3.2007.

    1.3.2007.

    Truvada

    Gilead Sciences International Limited

    Granta Park Abington

    Cambridge CB1 6GT

    United Kingdom

    EU/1/04/305/001

    5.3.2007.

    1.3.2007.

    Travatan

    Alcon Laboratories (UK) Ltd

    Boundary Way

    Hemel Hempstead

    Herts HP2 7UD

    United Kingdom

    EU/1/01/199/001-002

    5.3.2007.

    5.3.2007.

    Kinzalkomb

    Bayer HealthCare AG

    D-51368 Leverkusen

    EU/1/02/214/001-010

    7.3.2007.

    5.3.2007.

    MicardisPlus

    Boehringer Ingelheim International GmbH

    Binger Straβe 173

    D-55216 Ingelheim am Rhein

    EU/1/02/213/001-016

    7.3.2007.

    5.3.2007.

    Humira

    Abbott laboratories Ltd,

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/03/256/001-010

    7.3.2007.

    5.3.2007.

    NovoSeven

    Novo Nordisk A/S

    Novo Allé

    DK-2880 Bagsværd

    EU/1/96/006/001-003

    8.3.2007.

    5.3.2007.

    Trudexa

    Abbott laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/03/257/001-010

    7.3.2007.

    5.3.2007.

    Metalyse

    Boehringer Ingelheim International GmbH

    Binger Straβe 173

    D-55216 Ingelheim am Rhein

    EU/1/00/169/004-006

    7.3.2007.

    5.3.2007.

    Refludan

    Pharmion Limited

    Riverside House

    Riverside Walk

    Windsor SL4 1NA

    United Kingdom

    EU/1/97/035/001-004

    7.3.2007.

    5.3.2007.

    Micardis

    Boehringer Ingelheim International GmbH

    Binger Straβe 173

    D-55216 Ingelheim am Rhein

    EU/1/98/090/001-020

    7.3.2007.

    5.3.2007.

    Corlentor

    Les Laboratoires Servier

    22, rue Garnier

    F-92200 Neuilly-sur-Seine

    EU/1/05/317/001-014

    7.3.2007.

    6.3.2007.

    Aprovel

    Sanofi Pharma Bristol-Myers Squibb SNC

    174 avenue de France

    F-75013 Paris

    EU/1/97/046/001-033

    8.3.2007.

    6.3.2007.

    Karvea

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UD8 1DH

    United Kingdom

    EU/1/97/049/001-033

    8.3.2007.

    6.3.2007.

    Procolaran

    Les Laboratoires Servier

    22, rue Garnier

    F-92200 Neuilly-sur-Seine

    EU/1/05/316/001-014

    8.3.2007.

    6.3.2007.

    Bondronat

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/96/012/004

    EU/1/96/012/009-013

    8.3.2007.

    6.3.2007.

    Onsenal

    Pharmacia-Pfizer EEIG

    Ramsgate Road

    Sanwich CT13 9NJ

    United Kingdom

    EU/1/03/259/001-006

    8.3.2007.

    7.3.2007.

    Angiox

    The Medicines Company UK Ltd

    Suite B

    Park House

    11 Milton Park

    Abingdon

    Oxfordshire OX14 4RS

    United Kingdom

    EU/1/04/289/001-002

    9.3.2007.

    9.3.2007.

    Prevenar

    Wyeth-Lederle Vaccines S.A.

    Rue du Bosquet, 15

    B-1348 Louvain-La-Neuve

    EU/1/00/167/001-007

    13.3.2007.

    9.3.2007.

    Savene

    TopoTarget A/S

    Fruebjergvej 3

    DK-2100 København Ø

    EU/1/06/350/001

    13.3.2007.

    9.3.2007.

    Herceptin

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/00/145/001

    13.3.2007.

    14.3.2007.

    Synagis

    Abbott laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/99/117/001-002

    16.3.2007.

    14.3.2007.

    Alimta

    Eli Lilly Nederland BV

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/04/290/001

    16.3.2007.

    14.3.2007.

    Liprolog

    Eli Lilly Nederland BV

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/01/195/001-015

    16.3.2007.

    14.3.2007.

    Vasovist

    Schering AG

    Müllerstraβe 172-178

    D-13342 Berlin

    EU/1/05/313/001-009

    16.3.2007.

    20.3.2007.

    Kineret

    Amgen Europe BV

    Minervum 7061

    4817 ZK Breda

    Nederland

    EU/1/02/203/001-004

    22.3.2007.

    20.3.2007.

    GONAL-f

    Serono Europe Limited

    56 Marsh Wall

    London E14 9TP

    United Kingdom

    EU/1/95/001/033-035

    23.3.2007.

    21.3.2007.

    Aptivus

    Boehringer Ingelheim International GmbH

    Binger Straβe 173

    D-55216 Ingelheim am Rhein

    EU/1/05/315/001

    23.3.2007.

    21.3.2007.

    Invanz

    Merck Sharp & Dohme Ltd

    Hertford Road

    Hoddesdon

    Hertfordshire EN11 9BU

    United Kingdom

    EU/1/02/216/001-002

    23.3.2007.

    23.3.2007.

    Emselex

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/04/294/001-028

    27.3.2007.

    27.3.2007.

    Zimulti

    Sanofi-Aventis

    174, avenue de France

    F-75013 Paris

    EU/1/06/345/001-009

    29.3.2007.

    27.3.2007.

    ACOMPLIA

    Sanofi-Aventis

    174, avenue de France

    F-75013 Paris

    EU/1/06/344/001-009

    29.3.2007.

    27.3.2007.

    Emtriva

    Gilead Sciences International Limited

    Cambridge CB1 6GT

    United Kingdom

    EU/1/03/261/001-003

    29.3.2007.

    27.3.2007.

    Avastin

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/04/300/001-002

    29.3.2007.

    27.3.2007.

    Mabthera

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City

    AL7 1TW

    United Kingdom

    EU/1/98/067/001-002

    29.3.2007.

    27.3.2007.

    Remicade

    Centocor BV

    Einsteinweg 101

    2333 CB Leiden

    Nederland

    EU/1/99/116/001-003

    29.3.2007.

    27.3.2007.

    Liprolog

    Eli Lilly Nederland BV

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/01/195/001-015

    29.3.2007.

    27.3.2007.

    REYATAZ

    Bristol-Myers Squibb Pharma EEIG

    Uxbridge Business Park

    Sanderson Road

    Uxbridge UD8 1DH

    United Kingdom

    EU/1/03/267/001-007

    29.3.2007.

    27.3.2007.

    Optruma

    Eli Lilly Nederland BV

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/98/074/001-004

    30.3.2007.

    28.3.2007.

    Xagrid

    Shire Pharmaceutical Contracts Ltd

    Hampshire International Business Park

    Chineham

    Basingstoke

    Hampshire RG24 8EP

    United Kingdom

    EU/1/04/295/001

    30.3.2007.

    28.3.2007.

    Xeloda

    Roche Registration Limited

    6 Falcon Way Shire Park

    Welwyn Garden City

    Hertfordshire AL7 1TW

    United Kingdom

    EU/1/00/163/001-002

    30.3.2007.

    28.3.2007.

    Kaletra

    Abbott laboratories Ltd

    Queenborough

    Kent ME11 5EL

    United Kingdom

    EU/1/01/172/001-005

    30.3.2007.

    28.3.2007.

    Rebif

    Serono Europe Ltd

    56 Marsh Wall

    London E14 9TP

    United Kingdom

    EU/1/98/063/001-007

    30.3.2007.

    28.3.2007.

    Evista

    Eli Lilly Nederland BV

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/98/073/001-004

    30.3.2007.

    28.3.2007.

    Glivec

    Novartis Europharm Limited

    Wimblehurst Road

    Horsham

    West Sussex RH12 5AB

    United Kingdom

    EU/1/01/198/001-013

    30.3.2007.

    28.3.2007.

    NeuroBloc

    Solstice Neurosciences Ltd

    Fitzwilton House

    Wilton Place

    Dublin 2

    Ireland

    EU/1/00/166/001-003

    30.3.2007.

    28.3.2007.

    Zonegran

    Eisai Limited

    3 Shortlands

    London W6 8EE

    United Kingdom

    EU/1/04/307/001-013

    30.3.2007.

    28.3.2007.

    Tamiflu

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City

    AL7 1TW

    United Kingdom

    EU/1/02/222/001-002

    30.3.2007.

    28.3.2007.

    Humalog

    Eli Lilly Nederland BV

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/96/007/002

    EU/1/96/007/004

    EU/1/96/007/011

    EU/1/96/007/015

    EU/1/96/007/020-021

    EU/1/96/007/023

    EU/1/96/007/026

    30.3.2007.

    29.3.2007.

    Humalog

    Eli Lilly Nederland BV

    Grootslag 1-5

    3991 RA Houten

    Nederland

    EU/1/96/007/002

    EU/1/96/007/004-006

    EU/1/96/007/008

    EU/1/96/007/010-011

    EU/1/96/007/015-021

    EU/1/96/007/023-030

    2.4.2007.

    29.3.2007.

    Dynastat

    Pfizer Ltd

    Ramsgate Road

    Sandwich

    Kent CT13 9NJ

    United Kingdom

    EU/1/02/209/001-008

    2.4.2007.

    29.3.2007.

    DaTSCAN

    GE Healthcare Limited

    Little Chalfont

    Bucks HP7 9NA

    United Kingdom

    EU/1/00/135/001-002

    2.4.2007.

    29.3.2007.

    InductOs

    Wyeth Europa Ltd

    Huntercombe Lane South

    Taplow

    Maidenhead

    Berkshire, SL6 0PH

    United Kingdom

    EU/1/02/226/001

    2.4.2007.

    29.3.2007.

    Betaferon

    Schering Aktiengesellschaft

    D-13342 Berlin

    EU/1/95/003/003-006

    2.4.2007.

    29.3.2007.

    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

    4.4.2007.

    29.3.2007.

    Invirase

    Roche Registration Limited

    6 Falcon Way

    Shire Park

    Welwyn Garden City AL7 1TW

    United Kingdom

    EU/1/96/026/001-002

    2.4.2007.

    29.3.2007.

    Revatio

    Pfizer Ltd

    Ramsgate Road

    Sandwich

    Kent CT 13 9NJ

    United Kingdom

    EU/1/05/318/001

    4.4.2007.

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

    Lēmuma datums

    Zāļu nosaukums

    Tirdzniecības atļaujas turētājs

    Ieraksta numurs Kopienas reģistrā

    Paziņojuma datums

    14.3.2007.

    Previcox

    Merial

    29 avenue Tony Garnier

    F-69007 Lyon

    EU/2/04/045/007

    16.3.2007.

    14.3.2007.

    Nobivac Piro

    Intervet International BV

    Wim de Körverstraat 35

    5831 AN Boxmeer

    Nederland

    EU/2/04/046/001-003

    16.3.2007.

    Ja vēlaties apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, lūdzam sazināties ar

    The European Medicines Agency

    7, Westferry Circus, Canary Wharf

    London E14 4HB

    United Kingdom

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

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