EMA — authorised 16 February 2024
- Application: EMEA/H/C/006007
- Marketing authorisation holder: Pfizer Europe MA EEIG
- Local brand name: Velsipity
- Indication: Velsipity is indicated for the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
- Status: approved
On 16 February 2024, the European Medicines Agency (EMA) granted marketing authorisation for Velsipity, a treatment for moderately to severely active ulcerative colitis (UC). Velsipity is indicated for patients 16 years of age and older who have had an inadequate response, lost response, or were intolerant to conventional therapy or a biological agent. This authorisation allows Pfizer Europe MA EEIG to market Velsipity in the European Union.