Puldysa (idebenone)

Orphan

Region: 🇪🇺 EU
Active substance: idebenone
Company: Santhera Pharmaceuticals (Deutschland) GmbH
Status: Application withdrawn
Therapeutic area: Muscular Dystrophy, Duchenne
Designations: Orphan
Application: EMEA/H/C/005123
ATC: N06BX13
Official record: www.ema.europa.eu

Indication

Treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) not using glucocorticoids

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

🇪🇺 Raxone Authorised · Chiesi Farmaceutici S.p.A
🇪🇺 Raxone Application withdrawn · Santhera Pharmaceuticals (Deutschland) GmbH
🇪🇺 Sovrima Refused · Centocor B.V.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.