EMA — authorised 31 December 2009
- Application: EMEA/H/C/000908
- Marketing authorisation holder: Centocor B.V.
- Local brand name: Sovrima
- Indication: Treatment of Friedreichâ??s Ataxia
- Pathway: orphan
- Status: rejected
🇪🇺 Daruma in European Union
EMA authorised Daruma on 31 December 2009
Marketing authorisations
EMA — authorised 18 January 2013
- Application: EMEA/H/C/002425
- Marketing authorisation holder: Santhera Pharmaceuticals (Deutschland) GmbH
- Local brand name: Raxone
- Indication: Treatment of Lebers Hereditary Optic Neuropathy
- Pathway: orphan
- Status: withdrawn
EMA — authorised 8 September 2015
- Status: approved
EMA — authorised 8 September 2015
- Application: EMEA/H/C/003834
- Marketing authorisation holder: Chiesi Farmaceutici S.p.A
- Local brand name: Raxone
- Indication: Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).
- Pathway: exceptional circumstances
- Status: approved
EMA
- Application: EMEA/H/C/005123
- Marketing authorisation holder: Santhera Pharmaceuticals (Deutschland) GmbH
- Local brand name: Puldysa
- Indication: Treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) not using glucocorticoids
- Pathway: orphan
- Status: withdrawn
Daruma in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in European Union
Frequently asked questions
Is Daruma approved in European Union?
Yes. EMA authorised it on 31 December 2009; EMA authorised it on 18 January 2013; EMA authorised it on 8 September 2015.
Who is the marketing authorisation holder for Daruma in European Union?
Centocor B.V. holds the EU marketing authorisation.