Sweden and EU
- Lecigon was granted marketing authorization by the Swedish Medical Products Agency (MPA) on Oct 5th 2018, followed by a Swedish pricing and reimbursement approval in March 2019.
- In September 2019, the Swedish MPA confirmed End of Procedure according to the European Mutual Recognition Procedure (MRP) including Denmark, Finland and Norway. National market authorizations in these countries are expected to be finalized end of October, when the commercialization can be initiated.
- Lobsor is now focusing on obtaining further market authorizations in key markets in Europe.
US and Canada
- A US based company, Intrance Medical Systems Inc. is responsible for the development and commercialization of Lecigon in the US and Canada.