EMA — authorised 14 December 2012
- Application: EMEA/H/C/002371
- Marketing authorisation holder: Vanda Pharmaceuticals Ltd
- Local brand name: Fanaptum
- Indication: treatment of schizophrenia
- Status: withdrawn
🇪🇺 Fanapt in European Union
EMA authorised Fanapt on 14 December 2012
Marketing authorisations
EMA — authorised 15 January 2018
- Application: EMEA/H/C/004149
- Marketing authorisation holder: Vanda Pharmaceuticals Ltd
- Local brand name: Fanaptum
- Indication: Treatment of schizophrenia
- Status: rejected
EMA
- Application: EMEA/H/C/006561
- Marketing authorisation holder: Vanda Pharmaceuticals Netherlands B.V.
- Local brand name: Iloperidone Vanda Pharmaceuticals
- Indication: Treatment of schizophrenia, acute treatment of manic or mixed episodes associated with bipolar I disorder.
- Status: approved
Fanapt 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 Fanapt approved in European Union?
Yes. EMA authorised it on 14 December 2012; EMA authorised it on 15 January 2018; EMA has authorised it.
Who is the marketing authorisation holder for Fanapt in European Union?
Vanda Pharmaceuticals Ltd holds the EU marketing authorisation.