Klisyri (tirbanibulin)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tirbanibulin
- Company
- Almirall, S.A.
- Status
- Authorised
- Therapeutic area
- Keratosis, Actinic
- CHMP opinion
- Thu 20 May 2021
- EU approval
- Fri 16 Jul 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005183
- ATC
- D06BX03
- Official record
- www.ema.europa.eu
Indication
Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.
Regulatory milestones
No milestones recorded in the last year.
Follow Klisyri
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.