Vijoice (alpelisib)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- alpelisib
- Company
- Novartis Europharm Limited
- Status
- Application withdrawn
- Therapeutic area
- Genetic Diseases, Inborn; Growth Disorders
- Designations
- Orphan
- Application
- EMEA/H/C/005468
- ATC
- L01EM03
- Official record
- www.ema.europa.eu
Indication
Treatment of patients with severe manifestations of PIK3CA-related overgrowth spectrum
Regulatory milestones
Wed 15 Jul 2026🇪🇺 EU approval (EC decision)
Vijoice (alpelisib) approved in the EU
Marketing authorisation to Novartis Europharm Limited; Orphan, Conditional, Additional monitoring · source
Thu 21 May 2026🇪🇺 CHMP positive opinion
Vijoice (alpelisib): CHMP positive opinion
Novartis Europharm Limited; Orphan, Conditional, Additional monitoring · source
Same substance in other markets
- 🇪🇺 Piqray Authorised · Novartis Europharm Limited
- 🇪🇺 Vijoice Authorised · Novartis Europharm Limited
Follow Vijoice
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.