Givlaari (givosiran)
OrphanPRIMEAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- givosiran
- Company
- Alnylam Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Porphyrias, Hepatic
- CHMP opinion
- Thu 30 Jan 2020
- EU approval
- Mon 02 Mar 2020
- Designations
- Orphan, PRIME, Additional monitoring
- Application
- EMEA/H/C/004775
- ATC
- A16AX16
- Official record
- www.ema.europa.eu
Indication
Treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.
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.