Hyftor (sirolimus)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- sirolimus
- Company
- Plusultra pharma GmbH
- Status
- Authorised
- Therapeutic area
- Angiofibroma; Tuberous Sclerosis
- CHMP opinion
- Thu 23 Feb 2023
- EU approval
- Mon 15 May 2023
- Designations
- Orphan
- Application
- EMEA/H/C/005896
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Rapamune Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Torisel Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Opsiria Application withdrawn · Santen Oy
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.