Litfulo (ritlecitinib)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- ritlecitinib
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Alopecia Areata
- CHMP opinion
- Thu 20 Jul 2023
- EU approval
- Fri 15 Sep 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006025
- ATC
- L04AF08
- Official record
- www.ema.europa.eu
Indication
Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.
Regulatory milestones
Mon 10 Aug 2026🇪🇺 DHPC safety letter
Litfulo (ritlecitinib tosilate): DHPC sent to healthcare professionals
Adverse event, Post-authorisation measure, Restriction of indication; Alopecia Areata · source
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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.