Press release from the CHMP about a new indication for Zavesca (miglustat):
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE POST-AUTHORISATION SUMMARY OF POSITIVE OPINION for
International Nonproprietary Name (INN): miglustat
On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion to recommend the variation to the terms of the marketing authorisation for the medicinal product Zavesca. The Marketing Authorisation Holder for this medicinal product is Actelion Registration Ltd.
The CHMP adopted a new indication as follows: ‘‘treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease’’.
Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full indications for Zavesca will be as follows:
‘‘Zavesca is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.
Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease’’.