Molecule
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
From the regulator-approved product information. Each section names its source.
FILSUVEZ is 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. FILSUVEZ topical gel is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.
Source: US FDA prescribing information
The mechanism of action of FILSUVEZ in the treatment of wounds associated with epidermolysis bullosa is unknown.
Source: US FDA prescribing information
Wash hands before and after applying FILSUVEZ or wear gloves for application. Apply a 1 mm layer of FILSUVEZ to the affected wound surface only. Do not rub in the gel. Cover the wound with a sterile non-adhesive wound dressing. Alternatively, apply FILSUVEZ directly to the dressing so that the topical gel is in direct contact with the wound. Apply FILSUVEZ to cleansed wounds with wound dressing changes until the wound is healed. If a FILSUVEZ-treated wound becomes infected, discontinue treatment to that wound until the infection has resolved. Each tube of FILSUVEZ is for one-time use only. Once the tube is opened, use the product immediately. Discard the tube after use in household trash or through a drug take back site, if available. Avoid contact of FILSUVEZ with eyes and mucous membranes (e.g., mouth, vagina, anus). In case of accidental contact, irrigate the area with water.
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
Hypersensitivity Reactions: If signs or symptoms of hypersensitivity occur, discontinue use immediately and initiate appropriate therapy. Hypersensitivity Reactions Local hypersensitivity and skin reactions have been reported in patients treated with FILSUVEZ, including urticaria and dermatitis. If signs and symptoms of local or systemic hypersensitivity occur, discontinue FILSUVEZ immediately and initiate appropriate therapy.
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions The most common (incidence ≥2%) adverse reactions are application site reactions.
Source: US FDA prescribing information
Store at 20°C to 25°C (68° F to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) ). Do not freeze.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Birch triterpenes, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Filsuvez 10% gelTopical | Chiesi | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| 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 |
Yes, on request. MedsAcross lists 1 presentations of Birch triterpenes and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Birch triterpenes, including Filsuvez.
Yes. The US FDA first approved Birch triterpenes on 18 December 2023, according to Drugs@FDA.
No listed presentation of Birch triterpenes is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.