Medicine
Isembyld 150 mg/3 mL injection
Isembyld 150 mg/3 mL injection is a prescription medicine containing Apitegromab for intravenous use, marketed by Scholar Rock, 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
Store ISEMBYLD vials in a refrigerator between 2°C to 8°C (36°F to 46°F) in…
Key facts
- Active ingredient (INN)
- Apitegromab
- Brand
- Isembyld
- Strength
- 150 mg/3 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 3 mL
- Marketing authorisation holder
- Scholar Rock
- Manufacturer
- Scholar Rock
- Origin register
- US FDA, United States
- Storage
- Store ISEMBYLD vials in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. For storage of the diluted infusion solution, see Dosage and Administration.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M09AX Other musculoskeletal medicines, subgroup M09A, subgroup M09AX
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 September 2026
- Identifiers
- RxCUI 2753169, 2753176DailyMed set ID b1cd8ab8-8a10-48ed-9806-75a44f22b963NDC 84717-150Application BLA761463
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 in 1 carton / 3 mL in 1 vial | 84717-150-01 | Scholar Rock | 11 September 2026 |
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
Clinical summary
Apitegromab is a prescription medicine indicated for the treatment of spinal muscular atrophy (SMA) in adults and pediatric patients 2 years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment. MedsAcross supplies Apitegromab 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 ApitegromabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ISEMBYLD prescribing information (Scholar Rock) · U.S. National Library of Medicine, DailyMed
Need Isembyld 150 mg/3 mL injection 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.