This medicine is authorised for use in the European Union.


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 20/02/2023

Authorisation details

Product details
Agency product number
Active substance
fosdenopterin hydrobromide dihydrate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Metal Metabolism, Inborn Errors
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
Zydus France S.A.S.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Zydus France S.A.S.
Zac Les Hautes Patures
25 Rue Des Peupliers
92000 Nanterre

Product information

03/02/2023 Nulibry - EMEA/H/C/005378 - T/0002

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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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