Oslo, Norway, 1 December 2004.
PhotoCure ASA announces today that its European marketing authorisation application for Hexvix® for diagnosis of bladder cancer has been validated and found fileable in the European Mutual Recognition procedure in 26 EU/EEA countries.
The procedure starts today, and each country has committed to take a decision to recognise the already approved Swedish application within 90 days. National marketing authorisation in each country will be issued following the approval of the Hexvix® product information for doctors and patients in the local language.
Professor Vidar Hansson, PhotoCure's President and CEO, comments, "We are pleased that Hexvix® now has reached the marketing application phase in all EU/EEA countries. We take this as a recognition of PhotoCure's outstanding technology platform."