Oslo, 31 Januar 2002.
PhotoCure ASA announces today that the company has received marketing authorisation in Norway from the Norwegian Medicines Agency. The marketing authorisation is a result of the fact that the Norwegian Medicines Agency in December 2001 recognised the Swedish Drug Authorities' market authorisation of Metvix® PDT and that the Norwegian translation of the package insert etc. has been approved.
This is the first time a drug for treatment of diseases based on Norwegian academic research has been approved in Norway.
Based on this authorisation, PhotoCure now has the possibility to apply for price and reimbursement for the Metvix® cream before the product is properly launched in Norway.
Metvix® PDT is already launched in Sweden and approved in 13 other European countries. Norway is the first of these countries to grant a national market authorisation. In addition to this, applications for market authorisation are pending in Australia, New Zealand, USA and Switzerland.