Hyftor

sirolimus · Plusultra pharma GmbH
ORPHAN AUTHORISED IN THE EU

What Hyftor is used for

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

Approved use, as published by the European Medicines Agency.

What the labels mean

  • Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).

Key facts

Brand
Hyftor
Active substance
sirolimus
Disease area
Angiofibroma; Tuberous Sclerosis
Marketing authorisation holder
Plusultra pharma GmbH
Authorised in the EU since
2023

Official information

In the USA

Same active substance: Hyftor, Fyarro

In India

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Hyftor used for?

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

What is the active substance in Hyftor?

Hyftor contains sirolimus.

Who makes Hyftor?

The EU marketing authorisation holder is Plusultra pharma GmbH.

Is Hyftor an orphan medicine?

Yes. Hyftor is designated an orphan medicine in the EU, for a rare disease (Angiofibroma; Tuberous Sclerosis).

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

← All specialty medicines, EU

For information only, not medical advice. This page is a plain-language summary written from standard prescribing information and the public guides linked below. Brands sometimes change their formula, so always check the composition printed on the pack. Doses here are typical adult doses; yours may differ. Do not start, stop or change a medicine without your doctor or pharmacist, and keep all medicines away from children. In an emergency, call 112 (India) or your local emergency number.