candelll schreef op 16 augustus 2013 18:38:
www.thrombogenics.be/Health Canada approves ThromboGenics’ JETREA® for the treatment of symptomatic vitreomacular adhesion
16 Aug 2013
Canada is first market outside the US and Europe where JETREA® is approved
Leuven, August 16, 2013 – ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that Health Canada has approved JETREA® (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA). The priority review of the New Drug Submission for JETREA in Canada was conducted within 180 calendar days. Canada is the first market where JETREA® is approved outside the US and Europe. ThromboGenics’ partner Alcon holds the commercialization rights to JETREA® outside the US and will be responsible for the launch of the drug in Canada.
Alcon, a division of Novartis, acquired the rights to commercialize JETREA® outside the United States in March 2012. It launched the drug in the UK, its first European market, in April, followed by launches in Germany, Denmark, Finland, Norway and Sweden.
ThromboGenics is commercializing the drug in the US and launched JETREA® in the US in mid-January 2013 where it is approved for the treatment of patients with symptomatic vitreomacular adhesion (VMA).