Oxlumo

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Lumasiran

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

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.

This EPAR was last updated on 25/11/2020

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
A16AX
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
19/11/2020
Contact address

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

Product information

19/11/2020 Oxlumo - EMEA/H/C/005040 -

Contents

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Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Treatment of primary hyperoxaluria type 1 (PH1) in all age groups.

Assessment history

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