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Givlaari
Authorised
Human
Orphan medicine
Details
EMA number
EMEA/H/C/004775
ATC code
A16AX16
Authorisation
2 March 2020
Revision
7
EMA page
Therapeutic indication
Treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.
MeSH:
Porphyrias, Hepatic
Group:
Various alimentary tract and metabolism products
Special characteristics
Additional monitoring
Active substances
Givosiran
Marketing Authorisation Holder
Alnylam Netherlands B.V.
MAH
Timeline
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EMA
Givlaari authorised
2 Mar 2020
authorised
regulatory
Givlaari | uMedical