EMA — authorised 14 February 2007
- Marketing authorisation holder: Orphan Europe S.A.R.L.
- Status: approved
🇪🇺 Cystadane in European Union
EMA authorised Cystadane on 14 February 2007
Marketing authorisations
EMA — authorised 5 May 2022
- Application: EMEA/H/C/005637
- Marketing authorisation holder: SERB SA
- Local brand name: Amversio
- Indication: Amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in: cystathionine beta-synthase (CBS), 5,10 methylene tetrahydrofolate reductase (MTHFR), cobalamin cofactor metabolism (cbl).
- Status: approved
Cystadane in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in European Union
Frequently asked questions
Is Cystadane approved in European Union?
Yes. EMA authorised it on 14 February 2007; EMA authorised it on 5 May 2022.
Who is the marketing authorisation holder for Cystadane in European Union?
Orphan Europe S.A.R.L. holds the EU marketing authorisation.