Itvisma (onasemnogene abeparvovec)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- onasemnogene abeparvovec
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Muscular Atrophy, Spinal
- CHMP opinion
- Thu 23 Apr 2026
- EU approval
- Tue 30 Jun 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006498
- ATC
- M09AX09
- Official record
- www.ema.europa.eu
Indication
Itvisma is indicated for the treatment of 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene in patients 2 years of age and older.
Regulatory milestones
Tue 30 Jun 2026🇪🇺 EU approval (EC decision)
Itvisma (onasemnogene abeparvovec) approved in the EU
Marketing authorisation to Novartis Europharm Limited; Additional monitoring · source
Thu 23 Apr 2026🇪🇺 CHMP positive opinion
Itvisma (onasemnogene abeparvovec): CHMP positive opinion
Novartis Europharm Limited; Additional monitoring · source
Same substance in other markets
- 🇪🇺 Zolgensma Authorised · Novartis Europharm Limited
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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.