Givlaari
givosiran
Table of contents
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.
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List item
Givlaari : EPAR - Medicine overview (PDF/117.73 KB)
First published: 09/03/2020
EMA/62114/2020 -
List item
Givlaari : EPAR - Risk-management-plan summary (PDF/122.02 KB)
First published: 09/03/2020
Last updated: 22/06/2022
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 |
Not yet assigned
|
Additional 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. |
Orphan |
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 | |
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Marketing-authorisation holder |
Alnylam Netherlands B.V.
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
02/03/2020
|
Contact address |
Antonio Vivaldistraat 150 |
Product information
05/05/2022 Givlaari - EMEA/H/C/004775 - II/0006
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Therapeutic indication
Treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.