Medicine
Winrevair kit
Winrevair kit is a prescription medicine containing Sotatercept, marketed by Merck Sharp & Dohme, 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 vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to…
Key facts
- Active ingredient (INN)
- Sotatercept
- Brand
- Winrevair
- Dosage form
- Kit
- Packs
- 1 kit and 1 more
- Marketing authorisation holder
- Merck Sharp & Dohme
- Manufacturer
- Merck Sharp & Dohme
- Origin register
- US FDA, United States
- Storage
- Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. The kit should remain in the refrigerator until ready for use. The unused kit can be out of the refrigerator for (up to 25°C/77°F) up to 24 hours. For additional information on temperature excursions, call Merck Sharp & Dohme LLC at 1-800-672-6372.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C02KX06 Sotatercept
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 March 2024
- Identifiers
- RxCUI 2678937, 2678943, 2678945 +5DailyMed set ID 21693ee2-cd23-4137-ac67-066bb3a4a9b7NDC 0006-5090, 0006-5088, 0006-5091 +1Application BLA761363
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 kit in 1 carton * 1 mL in 1 vial, single-dose * 1 mL in 1 syringe | 0006-5087-01 | Merck Sharp & Dohme | 26 March 2024 |
| 1 kit in 1 carton * 1 mL in 1 vial, single-dose * 1.3 mL in 1 syringe | 0006-5088-01 | Merck Sharp & Dohme | 26 March 2024 |
| 1 kit in 1 carton * 1 mL in 1 vial, single-dose * 1 mL in 1 syringe | 0006-5090-01 | Merck Sharp & Dohme | 26 March 2024 |
| 1 kit in 1 carton * 1 mL in 1 vial, single-dose * 1.3 mL in 1 syringe | 0006-5091-01 | Merck Sharp & Dohme | 26 March 2024 |
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
Sotatercept is a prescription medicine. It is available as kits. MedsAcross supplies Sotatercept 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 SotaterceptFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- WINREVAIR prescribing information (Merck Sharp & Dohme) · U.S. National Library of Medicine, DailyMed
- Winrevair: European public assessment report (EPAR) · European Medicines Agency
Need Winrevair kit 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.