Cenrifki (tolebrutinib)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tolebrutinib
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis, Chronic Progressive
- CHMP opinion
- Thu 23 Apr 2026
- EU approval
- Fri 19 Jun 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006386
- ATC
- L04AA62
- Official record
- www.ema.europa.eu
Indication
Cenrifki is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) without relapses in the last 2 years.
Regulatory milestones
Fri 19 Jun 2026🇪🇺 EU approval (EC decision)
Cenrifki (tolebrutinib) approved in the EU
Marketing authorisation to Sanofi Winthrop Industrie; Additional monitoring · source
Thu 23 Apr 2026🇪🇺 CHMP positive opinion
Cenrifki (tolebrutinib): CHMP positive opinion
Sanofi Winthrop Industrie; Additional monitoring · 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.