Itvisma
Itvisma ingredients
| Active ingredient | Strength |
|---|---|
| Onasemnogene Abeparvovec | 40000000000000 [arb'U]/mL |
What Itvisma is used for
The FDA lists the approved uses on the official label (below). In the EU, onasemnogene abeparvovec is approved as Zolgensma for:
Zolgensma is indicated for the treatment of: patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1, or patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Itvisma
- Generic name
- Onasemnogene abeparvovec-brve
- Made by
- Novartis Innovative Technologies Inc.
- Forms
- Injection, Suspension
- Given
- Intrathecal
- FDA approval
- Biologic licence (BLA) BLA125856
- On the US market since
- 2025
Official information
- Itvisma prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Onasemnogene abeparvovec-brve)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Itvisma?
Itvisma (Onasemnogene abeparvovec-brve) is a specialist medicine made by Novartis Innovative Technologies Inc., approved by the US FDA.
What are the ingredients of Itvisma?
Itvisma contains Onasemnogene Abeparvovec (40000000000000 [arb'U]/mL).
Is Itvisma approved in Europe?
The same active substance is approved in the EU as Zolgensma.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA