EMA issue marketing authorisation for Nitisinone MDK, 2 mg, 5 mg and 10 mg, valid throughout the European Union.
Our European distribution partner WEP Clinical continue to make this life saving generic drug available to European Patient
WEP Clinical, a global pharmaceutical and services company, and MendeliKABS Inc., a Canadian pharmaceutical company dedicated to the treatment of rare diseases, announce an exclusive Named Patient agreement to commercialise MDK-Nitisinone (nitisinone), a drug for the treatment of hereditary tyrosinemia type 1, in a number of countries where the product has no valid Marketing Authorization in place.
MendeliKABS is proud to announce that Health Canada has approved MDK-Nitisinone medication for the treatment of hereditary tyrosinemia type 1. This is Health Canada’s first approval for a hereditary tyrosinemia type 1 medication. Nitisinone is used to treat hereditary tyrosinemia type 1 in combination with adherence to a reduced tyrosine dietary regime. Since its introduction in 1991, this treatment has replaced liver transplantation as a first line treatment for patients with this rare condition.