Oxlumo
Lumasiran
Table of contents
Overview
Oxlumo is a medicine used for treating primary hyperoxaluria type 1, an inherited disease in which a substance called oxalate builds up in the body, causing damage to the kidneys and other organs.
Oxlumo contains the active substance lumasiran.
Primary hyperoxaluria is rare, and Oxlumo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 21 March 2016.
-
List item
Oxlumo : EPAR - Medicine overview (PDF/102.36 KB)
Adopted
First published: 25/11/2020
EMA/561348/2020 -
List item
Oxlumo : EPAR - Risk-management-plan summary (PDF/261.52 KB)
First published: 25/11/2020
Last updated: 13/10/2022
Authorisation details
Product details | |
---|---|
Name |
Oxlumo
|
Agency product number |
EMEA/H/C/005040
|
Active substance |
Lumasiran sodium
|
International non-proprietary name (INN) or common name |
Lumasiran
|
Therapeutic area (MeSH) |
Hyperoxaluria, Primary
|
Anatomical therapeutic chemical (ATC) code |
A16AX18
|
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 | |
---|---|
Marketing-authorisation holder |
Alnylam Netherlands B.V.
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
19/11/2020
|
Contact address |
Antonio Vivaldistraat 150 |
Product information
25/05/2023 Oxlumo - EMEA/H/C/005040 - II/0014
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
Other alimentary tract and metabolism products
Therapeutic indication
Treatment of primary hyperoxaluria type 1 (PH1) in all age groups.