Medicine
Sohonos 2.5 mg capsule
Sohonos 2.5 mg capsule is a prescription medicine containing Palovarotene for oral use, marketed by Ipsen Biopharmaceuticals, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Palovarotene
- Brand
- Sohonos
- Strength
- 2.5 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 1 blister pack
- Marketing authorisation holder
- Ipsen Biopharmaceuticals
- Manufacturer
- Ipsen Biopharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). If not taken immediately, it can be taken after a maximum of one hour after the sprinkling, provided it was maintained at room temperature and not exposed to direct sunlight. SOHONOS must be kept in the original carton to protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M09AX11 Palovarotene
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 August 2023
- Identifiers
- RxCUI 2663960, 2663966, 2663968 +7DailyMed set ID 67dce406-7cc4-4d66-92de-ad18b6df0625NDC 15054-0025Application NDA215559
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 blister pack in 1 carton / 14 capsule in 1 blister pack | 15054-0025-1 | Ipsen Biopharmaceuticals | 16 August 2023 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 16 August 2023 | Drugs@FDA |
| EU (EMA) | Refused | EMA medicines data |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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 Palovarotene
Clinical summary
Palovarotene is a retinoid indicated for the reduction in volume of new heterotopic ossification in adults, among other approved uses. It is available as capsules for oral use. MedsAcross supplies Palovarotene 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 PalovaroteneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SOHONOS prescribing information (Ipsen Biopharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Sohonos 2.5 mg capsule 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.