Rhapsido (remibrutinib)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- remibrutinib
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Urticaria
- CHMP opinion
- Thu 26 Feb 2026
- EU approval
- Thu 23 Apr 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006313
- ATC
- L04AA60
- Official record
- www.ema.europa.eu
Indication
Rhapsido is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment.
Regulatory milestones
Thu 23 Apr 2026🇪🇺 EU approval (EC decision)
Rhapsido (remibrutinib) approved in the EU
Marketing authorisation to Novartis Europharm Limited; Additional monitoring · source
Thu 26 Feb 2026🇪🇺 CHMP positive opinion
Rhapsido (remibrutinib): CHMP positive opinion
Novartis Europharm Limited; Additional monitoring · source
Same substance in other markets
- 🇺🇸 Rhapsido Approved · Novartis
Follow Rhapsido
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.