This medicine is authorised for use in the European Union.


Hyftor is a medicine used to treat benign (non-cancerous) skin tumours on the face (facial angiofibroma) that are caused by a genetic disease called tuberous sclerosis complex. It is used in adults and children aged 6 years and older.

Tuberous sclerosis complex is rare, and Hyftor was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 23 August 2017. Further information on the orphan designation can be found on the EMA website.

Hyftor is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Hyftor is given in a different way. While the reference medicine, Rapamune, is given by mouth (tablets or a liquid to be drunk), Hyftor is available as a gel to be applied to the skin.

Hyftor contains the active substance sirolimus.

This EPAR was last updated on 25/09/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Angiofibroma
  • Tuberous Sclerosis

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Plusultra pharma GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Fritz-Vomfelde-Strasse 36
40547 Duesseldorf

Product information

22/09/2023 Hyftor - EMEA/H/C/005896 - N/0002

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Not yet assigned

Therapeutic indication

Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.

Assessment history

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