Beqvez (previously Durveqtix) (fidanacogene elaparvovec)
PRIMEATMPConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- fidanacogene elaparvovec
- Company
- Pfizer Europe MA EEIG
- Status
- Withdrawn
- Therapeutic area
- Hemophilia B
- CHMP opinion
- Thu 30 May 2024
- EU approval
- Wed 24 Jul 2024
- Designations
- PRIME, ATMP, Conditional, Additional monitoring
- Application
- EMEA/H/C/004774
- Official record
- www.ema.europa.eu
Regulatory milestones
No milestones recorded in the last year.
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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.