Indications
Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.
Composition
- Active substance
- sirolimus
Official product information
The European public assessment report holds the summary of product characteristics and the package leaflet in every EU language.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Medicine
- Hyftor
- Active substance
- sirolimus
- Therapeutic area
- Angiofibroma, Tuberous Sclerosis
- Marketing authorisation holder
- Plusultra pharma GmbH
- Status
- Authorised
- EU authorisation
- 15 May 2023
- EMA product number
- EMEA/H/C/005896
EMA designations
- Orphan medicine
- Yes
- Conditional approval
- No
- Biosimilar
- No
- Generic
- No
- Accelerated assessment
- No
- Additional monitoring
- No
- Patient safety information
- No