Medicine
Itvisma 40000000000000 units/mL injectable suspension
Itvisma 40000000000000 units/mL injectable suspension is a prescription medicine containing Onasemnogene abeparvovec for intrathecal use, marketed by Novartis Innovative Technologies, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Upon receipt, immediately place the carton in a refrigerator at 2°C to 8°C…
Key facts
- Active ingredient (INN)
- Onasemnogene abeparvovec
- Brand
- Itvisma
- Strength
- 40000000000000 units/mL
- Dosage form
- Injectable suspension
- Route
- Intrathecal
- Packs
- 1 vial
- Marketing authorisation holder
- Novartis Innovative Technologies
- Manufacturer
- Novartis Innovative Technologies
- Origin register
- US FDA, United States
- Storage
- Upon receipt, immediately place the carton in a refrigerator at 2°C to 8°C (36°F to 46°F). ITVISMA is stable for 14 days from receipt when stored at 2°C to 8°C (36°F to 46°F). Product is shipped and delivered frozen (≤ -60°C [-76°F]) in a single-dose clear vial.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M09AX09 Onasemnogene abeparvovec
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 November 2025
- Identifiers
- RxCUI 2727307, 2727314DailyMed set ID ab2e1c6c-4f95-4243-9296-1734e0a30591NDC 71894-200Application BLA125856
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 3 mL in 1 vial, single-dose | 71894-200-02 | Novartis Innovative Technologies | 24 November 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Onasemnogene abeparvovec
Clinical summary
Onasemnogene abeparvovec is a prescription medicine indicated for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in survival motor neuron 1 (SMN1) gene. MedsAcross supplies Onasemnogene abeparvovec for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Onasemnogene abeparvovecFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ITVISMA prescribing information (Novartis Innovative Technologies) · U.S. National Library of Medicine, DailyMed
- Itvisma: European public assessment report (EPAR) · European Medicines Agency
- Zolgensma: European public assessment report (EPAR) · European Medicines Agency
Need Itvisma 40000000000000 units/mL injectable suspension for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.