This medicine is authorised for use in the European Union.


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 19/07/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
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.


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
Contact address

Antonio Vivaldistraat 150
Cross Towers, 20th floor
1083 HP Amsterdam
The Netherlands

Product information

08/06/2023 Givlaari - EMEA/H/C/004775 - II/0011/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Various alimentary tract and metabolism products

Therapeutic indication

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

Assessment history

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