Medicine
Filsuvez 10% gel
Filsuvez 10% gel is a prescription medicine containing Birch triterpenes for topical use, marketed by Chiesi, 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
Do not freeze. Store at 20°C to 25°C (68° F to 77°F), excursions permitted to…
Key facts
- Active ingredient (INN)
- Birch triterpenes
- Brand
- Filsuvez
- Strength
- 10%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 tube
- Marketing authorisation holder
- Chiesi
- Manufacturers
- ChiesiAmryt Pharmaceuticals DAC
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20°C to 25°C (68° F to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) ).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 February 2024
- Identifiers
- RxCUI 2675587, 2675592DailyMed set ID 32ba9194-734c-47d4-84e1-b21e28a85ec5, da793f2d-0a3d-4792-8c22-982f9f8cdd97NDC 10122-310, 76431-310Application NDA215064
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 tube in 1 carton / 23.4 g in 1 tube | 10122-310-02 | Chiesi | 22 February 2024 |
| 1 tube in 1 carton / 23.4 g in 1 tube | 76431-310-01 | Amryt Pharmaceuticals DAC | 22 February 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 18 December 2023 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| 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
Clinical summary
Birch triterpenes is a prescription medicine indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older. MedsAcross supplies Birch triterpenes 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 Birch triterpenesFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- FILSUVEZ prescribing information (Chiesi) · U.S. National Library of Medicine, DailyMed
Need Filsuvez 10% gel 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.