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Document 52013XC0426(04)

    Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill- 1 ta’ Marzu 2013 sal- 31 ta’ Marzu 2013 (Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

    ĠU C 121, 26.4.2013, p. 2–7 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    26.4.2013   

    MT

    Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

    C 121/2

    Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Marzu 2013 sal-31 ta’ Marzu 2013

    (Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill  (1) )

    2013/C 121/02

    —   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

    Data tad-deċiżjoni

    Isem tal-prodott mediċinali

    INN (Denominazzjoni Internazzjonali Komuni)

    Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

    Numru tal-entrata fir-Reġistru Komunitarju

    Forma farmaċewtika

    Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

    Data ta' notifika

    4.3.2013

    Perjeta

    pertuzumab

    Roche Registration Limited

    6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

    EU/1/13/813

    Konċentrat għal soluzzjoni għal infużjoni

    L01XC13

    6.3.2013

    13.3.2013

    Actelsar HCT

    Telmisartan/hydrochlorothiazide

    Actavis Group PTC ehf.

    Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

    EU/1/13/817

    Pillola

    C09DA07

    15.3.2013

    13.3.2013

    JETREA

    ocriplasmin

    ThromboGenics NV

    Gaston Geenslaan 1, B-3001 Leuven, België

    EU/1/13/819

    Konċentrat għal soluzzjoni għall injezzjoni

    Pending

    15.3.2013

    13.3.2013

    Tolucombi

    telmisartan/hydrochlorothiazide

    Krka, d. d., Novo mesto

    Šmarješka cesta 6, 8501 Novo mesto, Slovenija

    EU/1/13/821

    Pillola

    C09DA07

    15.3.2013

    22.3.2013

    Bexsero

    Tilqima Meningokokkali ta' Grupp B (rDNA, komponent, adsorbit)

    Novartis Vaccines and Diagnostics S.r.l.

    Via Fiorentina, 1, 53100 Siena, Italia

    EU/1/12/812

    Suspensjoni għall-injezzjoni

    J07AH09

    26.3.2013

    27.3.2013

    Bosulif

    Bosutinib

    Pfizer Limited

    Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

    EU/1/13/818

    Pillola miksija b’rita

    L01XE14

    2.4.2013


    —   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

    Data tad-deċiżjoni

    Isem tal-prodott mediċinali

    Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

    Numru tal-entrata fir-Reġistru Komunitarju

    Data ta' notifika

    6.3.2013

    Byetta

    Bristol-Myers Squibb/AstraZeneca EEIG

    Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

    EU/1/06/362

    8.3.2013

    6.3.2013

    Intelence

    Janssen-Cilag International NV

    Turnhoutseweg 30, B-2340 Beerse, België

    EU/1/08/468

    8.3.2013

    6.3.2013

    Ozurdex

    Allergan Pharmaceuticals Ireland

    Castlebar Road, Westport, Co. Mayo, Ireland

    EU/1/10/638

    8.3.2013

    6.3.2013

    Ranexa

    Menarini International Operations Luxembourg S.A.

    1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg

    EU/1/08/462

    8.3.2013

    11.3.2013

    Champix

    Pfizer Limited

    Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

    EU/1/06/360

    13.3.2013

    11.3.2013

    Qutenza

    Astellas Pharma Europe B.V.

    Sylviusweg 62, NL-2333 BE Leiden, Nederland

    EU/1/09/524

    13.3.2013

    11.3.2013

    Victoza

    Novo Nordisk A/S

    Novo Allé, DK-2880 Bagsvaerd, Danmark

    EU/1/09/529

    13.3.2013

    13.3.2013

    BYDUREON

    Bristol-Myers Squibb/AstraZeneca EEIG

    Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

    EU/1/11/696

    15.3.2013

    13.3.2013

    Efficib

    Merck Sharp & Dohme Limited

    Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

    EU/1/08/457

    15.3.2013

    13.3.2013

    Firazyr

    Shire Orphan Therapies GmbH

    Friedrichstrasse 149, D-10117 Berlin, Deutschland

    EU/1/08/461

    15.3.2013

    13.3.2013

    Firdapse

    BioMarin Europe Ltd

    164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

    EU/1/09/601

    15.3.2013

    13.3.2013

    Ganfort

    Allergan Pharmaceuticals Ireland, (514125)

    Castlebar Road, Westport, County Mayo, Ireland

    EU/1/06/340

    15.3.2013

    13.3.2013

    Iscover

    Sanofi-Aventis groupe

    54 rue La Boétie, F-75008 Paris, France

    EU/1/98/070

    15.3.2013

    13.3.2013

    Janumet

    Merck Sharp & Dohme Limited

    Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

    EU/1/08/455

    15.3.2013

    13.3.2013

    Optimark

    Mallinckrodt Deutschland GmbH

    Josef-Dietzgen-Strasse 1, 53773 Hennef, Deutschland

    EU/1/07/398

    15.3.2013

    13.3.2013

    Pegasys

    Roche Registration Limited

    6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

    EU/1/02/221

    15.3.2013

    13.3.2013

    Privigen

    CSL Behring GmbH

    Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland

    EU/1/08/446

    15.3.2013

    13.3.2013

    Velmetia

    Merck Sharp & Dohme Limited

    Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

    EU/1/08/456

    15.3.2013

    13.3.2013

    Vidaza

    Celgene Europe Limited

    1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

    EU/1/08/488

    15.3.2013

    22.3.2013

    Daliresp

    Takeda GmbH

    Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

    EU/1/11/668

    26.3.2013

    22.3.2013

    DaTSCAN

    GE Healthcare Limited

    Little Chalfont, Bucks HP7 9NA, United Kingdom

    EU/1/00/135

    26.3.2013

    22.3.2013

    Daxas

    Takeda GmbH

    Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

    EU/1/10/636

    26.3.2013

    22.3.2013

    Emend

    Merck Sharp & Dohme Limited

    Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

    EU/1/03/262

    26.3.2013

    22.3.2013

    Ivemend

    Merck Sharp & Dohme Limited

    Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

    EU/1/07/437

    26.3.2013

    22.3.2013

    Libertek

    Takeda GmbH

    Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

    EU/1/11/666

    26.3.2013

    22.3.2013

    Pixuvri

    CTI Life Sciences Ltd

    Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom

    EU/1/12/764

    26.3.2013

    26.3.2013

    Combivir

    ViiV Healthcare UK Limited

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

    EU/1/98/058

    28.3.2013

    26.3.2013

    Daliresp

    Takeda GmbH

    Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

    EU/1/11/668

    28.3.2013

    26.3.2013

    Daxas

    Takeda GmbH

    Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

    EU/1/10/636

    28.3.2013

    26.3.2013

    Epivir

    ViiV Healthcare UK Limited

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

    EU/1/96/015

    28.3.2013

    26.3.2013

    Kivexa

    ViiV Healthcare UK Limited

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

    EU/1/04/298

    28.3.2013

    26.3.2013

    Libertek

    Takeda GmbH

    Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

    EU/1/11/666

    28.3.2012

    26.3.2013

    Privigen

    CSL Behring GmbH

    Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland

    EU/1/08/446

    28.3.2013

    26.3.2013

    Telzir

    ViiV Healthcare UK Limited

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

    EU/1/04/282

    28.3.2013

    26.3.2013

    Trizivir

    ViiV Healthcare UK Limited

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

    EU/1/00/156

    28.3.2013

    26.3.2013

    Ziagen

    ViiV Healthcare UK Limited

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

    EU/1/99/112

    28.3.2013

    27.3.2013

    Cervarix

    GlaxoSmithKline Biologicals S.A.

    rue de l'Institut 89, 1330 Rixensart, Belgique

    EU/1/07/419

    29.3.2013


    —   Irtirar ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

    Data tad-deċiżjoni

    Isem tal-prodott mediċinali

    Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

    Numru tal-entrata fir-Reġistru Komunitarju

    Data ta' notifika

    27.3.2013

    Bondenza

    Roche Registration Limited

    6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

    EU/1/03/266

    2.4.2013

    27.3.2013

    Possia

    AstraZeneca AB

    SE-151 85 Södertälje, Sverige

    EU/1/10/656

    2.4.2013


    —   Sospensjoni ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 20 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

    Data tad-deċiżjoni

    Isem tal-prodott mediċinali

    Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

    Numru tal-entrata fir-Reġistru Komunitarju

    Data ta' notifika

    22.3.2013

    Pelzont

    Merck Sharp & Dohme Limited

    Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

    EU/1/08/460

    26.3.2013

    22.3.2013

    Tredaptive

    Merck Sharp & Dohme Limited

    Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

    EU/1/08/459

    26.3.2013

    22.3.2013

    Trevaclyn

    Merck Sharp & Dohme Limited

    Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

    EU/1/08/458

    26.3.2013


    —   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

    Data tad-deċiżjoni

    Isem tal-prodott mediċinali

    Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

    Numru tal-entrata fir-Reġistru Komunitarju

    Data ta' notifika

    6.3.2013

    Loxicom

    Norbrook Laboratories Ltd

    Station Works, Newry, Co. Down, BT35 6JP, United Kindgom

    EU/2/08/090

    8.3.2013

    6.3.2013

    ProteqFlu

    Merial

    29 avenue Tony Garnier, F-69007 Lyon, France

    EU/2/03/037

    8.3.2013

    6.3.2013

    ProteqFlu-Te

    Merial

    29 avenue Tony Garnier, F-69007 Lyon, France

    EU/2/03/038

    8.3.2013

    Kull min jixtieq jikkonsulta r-rapport ta' evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

    The European Medicines Agency

    7, Westferry Circus,

    Canary Wharf

    UK-LONDON E14 4H

    (1)  ĠU L 136, 30.4.2004, p. 1.

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