Onsolis filed in Canada The registration file for Onsolis (fentanyl buccal soluble film) has been submitted to the Canadian regulatory authority; Health Canada. If approved, it may become the first available fentanyl product approved for breakthrough pain in opioid tolerant patients with cancer in Canada. A decision by Health Canada is expected during 2010. Canada represents an important market for Onsolis. The product will be commercialized by the joint venture between Meda and Valeant (Meda Valeant Pharma Canada Inc.). About Onsolis Onsolis is a new and patented product, indicated for the management of breakthrough pain in cancer patients who are tolerant to opioid therapy. Onsolis uses a unique delivery system designed to give rapid and reliable delivery of fentanyl. The product consists of a small dissolvable disc for application of fentanyl to the buccal (inner lining of cheek) membranes. Onsolis has been approved in the US and launch is expected to begin this month. In Europe, Onsolis is under regulatory review with approval expected in 2010. For more information, please contact: Anders Larnholt, Vice President Investor Relations, tel. +46 709 458 878 MEDA AB (publ) is a leading international specialty pharma company. Meda's products are sold in 120 countries worldwide and the company is represented by its own organizations in more than 40 countries. The Meda share is listed under Large Cap on the Nasdaq OMX Nordic Stock Exchange in Stockholm. Find out more, visit www.meda.se.
Onsolis filed in Canada
| Source: Meda AB