EMA — authorised 20 November 2002
- Status: approved
🇪🇺 Zavesca in European Union
EMA authorised Zavesca on 20 November 2002
Marketing authorisations
EMA — authorised 20 November 2002
- Application: EMEA/H/C/000435
- Marketing authorisation holder: Janssen Cilag International NV
- Local brand name: Zavesca
- Indication: 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.
- Status: approved
Zavesca in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Zavesca approved in European Union?
Yes. EMA authorised it on 20 November 2002; EMA authorised it on 20 November 2002.
Who is the marketing authorisation holder for Zavesca in European Union?
AstraZeneca is the originator. The local marketing authorisation holder may differ — check the official source linked above.