Nulibry

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fosdenopterin

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

Overview

Nulibry is a medicine used to treat patients with molybdenum cofactor deficiency (MoCD) type A.

MoCD type A is an inherited disease where patients do not have enough of a substance called 'molybdenum cofactor', a molecule needed for the production of certain enzymes. Without these enzymes, the toxic chemical sulfite builds up in the brain causing brain damage.

In the 'type A' form of the disease, the absence of molybdenum cofactor is due to patients lacking a substance called 'cyclic pyranopterin monophosphate (cPMP)’, which the body needs to make molybdenum cofactor.

MoCD type A is rare, and Nulibry was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 20 September 2010. Further information on the orphan designation can be found here.

Nulibry contains the active substance fosdenopterin.

This EPAR was last updated on 30/09/2022

Authorisation details

Product details
Name
Nulibry
Agency product number
EMEA/H/C/005378
Active substance
fosdenopterin hydrobromide dihydrate
International non-proprietary name (INN) or common name
fosdenopterin
Therapeutic area (MeSH)
Metal Metabolism, Inborn Errors
Anatomical therapeutic chemical (ATC) code
A16AX19
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
Comharsa Life Sciences Ltd
Date of issue of marketing authorisation valid throughout the European Union
15/09/2022
Contact address

10 Earlsfort Terrace
Dublin 2 D02 T380
Ireland

Product information

15/09/2022 Nulibry - EMEA/H/C/005378 -

Other EU languages available icon This medicine’s product information is available in all official EU languages.
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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

Other alimentary tract and metabolism products

Therapeutic indication

NULIBRY is indicated for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

Assessment history

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