Medicine
Elaprase 6 mg/3 mL injection
Elaprase 6 mg/3 mL injection is a prescription medicine containing Idursulfase for intravenous use, marketed by Takeda 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 ELAPRASE vials in the carton at 2°C to 8°C (36°F to 46°F) to protect…
Key facts
- Active ingredient (INN)
- Idursulfase
- Brand
- Elaprase
- Strength
- 6 mg/3 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 3 mL
- Marketing authorisation holder
- Takeda Pharmaceuticals
- Manufacturer
- Takeda Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store ELAPRASE vials in the carton at 2°C to 8°C (36°F to 46°F) to protect from light. Do not freeze or shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AB09 Idursulfase
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 July 2006
- Identifiers
- RxCUI 644104, 647118DailyMed set ID 60cba843-5aab-4dd7-96dc-66648d413be3NDC 54092-700Application BLA125151
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, glass in 1 box / 3 mL in 1 vial, glass | 54092-700-01 | Takeda Pharmaceuticals | 24 July 2006 |
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
Idursulfase is a hydrolytic lysosomal glycosaminoglycan-specific enzyme indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). It is available as injection for intravenous use. MedsAcross supplies Idursulfase 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 IdursulfaseFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ELAPRASE prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Elaprase: European public assessment report (EPAR) · European Medicines Agency
Need Elaprase 6 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.