Medicine
Rylaze 10 mg/0.5 mL injection
Rylaze 10 mg/0.5 mL injection is a prescription medicine containing Asparaginase for intramuscular use, marketed by Jazz Pharmaceuticals, 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 RYLAZE vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original…
Key facts
- Active ingredient (INN)
- Asparaginase
- Brand
- Rylaze
- Strength
- 10 mg/0.5 mL
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 3 vials of 0.5 mL
- Marketing authorisation holder
- Jazz Pharmaceuticals
- Manufacturer
- Jazz Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store RYLAZE vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake or freeze.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XX02 Asparaginase
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 June 2021
- Identifiers
- RxCUI 2561251, 2561256DailyMed set ID 857e53aa-1098-4dad-b654-0276cdd43e03NDC 68727-900Application BLA761179
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 |
|---|---|---|---|
| 3 vial, single-dose in 1 carton / .5 mL in 1 vial, single-dose | 68727-900-03 | Jazz Pharmaceuticals | 30 June 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
Asparaginase is an asparagine-specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older. MedsAcross supplies Asparaginase 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 AsparaginaseFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Rylaze prescribing information (Jazz Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Spectrila: European public assessment report (EPAR) · European Medicines Agency
Need Rylaze 10 mg/0.5 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.