EMA
- Application: EMEA/H/C/004938
- Marketing authorisation holder: Mitsubishi Tanabe Pharma GmbH
- Local brand name: Radicava
- Indication: Treatment of amyotrophic lateral sclerosis.
- Pathway: orphan
- Status: withdrawn
Radicava (Radicava) regulatory status in European Union.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA has authorised it.
Mitsubishi Tanabe Pharma GmbH holds the EU marketing authorisation.