PhotoCure - Hexvix® application in EU / EEA countries to be filed later this year
Oslo, Norway, 23 September 2004
PhotoCure has previously informed that the Swedish regulatory authorities had finished the review for marketing approval for its novel imaging drug Hexvix.
Yesterday, PhotoCure received the written notice confirming the marketing approval of Hexvix in Sweden. Based on the positive Swedish assessment, PhotoCure will submit marketing authorisation applications in the majority of the remaining EU/EEA countries later this year. The filing will be made through the Mutual Recognition Procedure, by which each country must give its response within 90 days following the application date.
Hexvix is approved for detection of bladder cancer in patients with known or suspected bladder cancer. This product is the first on the market that improves cystoscopic diagnosis of bladder cancer. Bladder cancer is the sixth most common malignant disease worldwide. Approximately 5 million cystoscopies are performed in the USA and Europe every year.