Onasemnogene abeparvovec

Itvisma

4x10^13VG/ML InjectionUnited StatesMarketedAuthorised 24 Nov 2025

In other countries

The same active substances on other registers, the same brand first.

ItvismaEuropean Union · Novartis Europharm LimitedSame brand
ItvismaCroatiaSame brand
Itvisma 1,2 × 1014 vectorgenomen oplossing voor injectieNetherlands · Oplossing voor injectie · Novartis Europharm LimitedSame brand
ZOLGENSMA 2 x 10e13 GENOMAS VECTORIALES/ML SOLUCION PARA PERFUSIONSpain · 2 x 10e13 Genoma vectorial · solución para perfusión · Novartis Europharm LimitedSame form
ZolgensmaItaly · Soluzione per infusione · Novartis Europharm LimitedSame form
ZOLGENSMA 2 x 10¹³ vg/ml, oplossing voor infusieNetherlands · Oplossing voor infusie · Novartis Europharm LimitedSame form

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Onasemnogene abeparvovec

Itvisma

4x10^13VG/ML InjectionUnited StatesMarketedAuthorised 24 Nov 2025

Ask Osler about it

In other countries

The same active substances on other registers, the same brand first.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Zolgensma

Brazil · Novartis Biociencias S.A

ZolgensmaCanada · 20000000000000 VG / ML · Solution · Novartis Pharmaceuticals Canada INC

ZolgensmaEuropean Union · Novartis Europharm Limited

ZolgensmaCroatia

ZolgensmaSaudi Arabia · Novartis Gene Therapies, Inc

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

U.S. Food and Drug Administration

FDA Purple Book, September 2026 release; acquired 2026-10-10T15:29:54.330165+00:00; exact source fields retained with source-key projections.

Licence: FDA-created structured factual administrative metadata; public-domain policy with third-party exceptions · Added 11 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Onasemnogene abeparvovec
Strength: 4x10^13VG/ML
Dosage form: Injection
Route: Intrathecal
Register: United States (FDA)
Status: Marketed
Status in the register: Licensed / Rx
Authorised: 24 Nov 2025
Registration: BLA 125856
Marketing authorisation holder: Novartis Gene Therapies, Inc.
Procedure: 351(a)
Supply: Rx