Medicine
Fyarro 5 mg/mL powder for injectable suspension
Fyarro 5 mg/mL powder for injectable suspension is a prescription medicine containing Sirolimus for intravenous use, marketed by Aadi Bioscience, 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 the vials in the original cartons at 2° to 8°C [USP Refrigerated…
Key facts
- Active ingredient (INN)
- Sirolimus
- Brand
- Fyarro
- Strength
- 5 mg/mL
- Dosage form
- Powder for injectable suspension
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Aadi Bioscience
- Manufacturer
- Aadi Bioscience
- Origin register
- US FDA, United States
- Storage
- Store the vials in the original cartons at 2° to 8°C [USP Refrigerated Temperature] (36° to 46°F). Retain in the original package to protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AH01 Sirolimus
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 December 2021
- Identifiers
- RxCUI 2586863, 2586868DailyMed set ID 0f9bb784-53e2-46f9-a65d-1c6c2a230eafNDC 80803-153Application NDA213312
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-use in 1 carton / 20 mL in 1 vial, single-use | 80803-153-50 | Aadi Bioscience | 6 December 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
Other strengths and forms of Sirolimus
Clinical summary
Sirolimus is a kinase inhibitor indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants, among other approved uses. MedsAcross supplies Sirolimus 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 SirolimusFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sirolimus prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Hyftor: European public assessment report (EPAR) · European Medicines Agency
- Rapamune: European public assessment report (EPAR) · European Medicines Agency
Need Fyarro 5 mg/mL powder for 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.