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.