Givlaari

RSS

givosiran

Authorised
This medicine is authorised for use in the European Union.

Overview

Givlaari is a medicine for treating acute hepatic porphyria in patients aged 12 years or over.

Acute hepatic porphyria is a rare genetic condition in which the liver cannot properly produce a substance called haem. As a result, substances used to make haem build up in the body, causing attacks of severe abdominal pain, vomiting and nervous system disorders.

Acute hepatic porphyria is rare, and Givlaari was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 29 August 2016.

This EPAR was last updated on 09/03/2020

Authorisation details

Product details
Name
Givlaari
Agency product number
EMEA/H/C/004775
Active substance
Givosiran
International non-proprietary name (INN) or common name
givosiran
Therapeutic area (MeSH)
Porphyrias, Hepatic
Anatomical therapeutic chemical (ATC) code
-
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Alnylam Netherlands B.V.
Date of issue of marketing authorisation valid throughout the European Union
02/03/2020
Contact address

Strawinskylaan 3051
1077 ZX Amsterdam
Netherlands

Product information

02/03/2020 Givlaari - EMEA/H/C/004775 -

Contents

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Pharmacotherapeutic group

Not yet assigned

Therapeutic indication

Treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.

Assessment history

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