Medicine
Nexviazyme 100 mg/10 mL powder for injection
Nexviazyme 100 mg/10 mL powder for injection is a prescription medicine containing Avalglucosidase alfa for intravenous use, marketed by Genzyme, 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 refrigerated at 2°C to 8°C (36°F to 46°F).
Key facts
- Active ingredient (INN)
- Avalglucosidase alfa
- Brand
- Nexviazyme
- Strength
- 100 mg/10 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Genzyme
- Manufacturer
- Genzyme
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16 Metabolic disease treatments, including enzyme replacement
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 August 2021
- Identifiers
- RxCUI 2565818, 2565823DailyMed set ID 80eb3c9c-01d3-44fe-90ef-81df101b954dNDC 58468-0426Application BLA761194
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 / 10 mL in 1 vial, single-dose | 58468-0426-1 | Genzyme | 6 August 2021 |
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
Avalglucosidase alfa is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency). MedsAcross supplies Avalglucosidase alfa 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 Avalglucosidase alfaFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nexviazyme prescribing information (Genzyme) · U.S. National Library of Medicine, DailyMed
- Nexviadyme: European public assessment report (EPAR) · European Medicines Agency
Need Nexviazyme 100 mg/10 mL powder for 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.