Detailed SMPC and OD register data for: Nulibry 9.5 mg powder for solution for injection
Data as extracted from Orphan Designation Register
Product (OD)
Nulibry 9.5 mg powder for solution for injection
PL number (OD)
PLGB 24576/0009
OD Designation ID (OD)
OD1
Active substance (OD)
Fosdenopterin hydrobromide dihydrate
Data as extracted from SMPC. (PS: More information at bottom of the page)
Product (SMPC)
PL Number (SMPC)
Composition/ Active Substance (SMPC)
Dose form (SMPC)
Marketing Authorisation holder details (SMPC)
AI match to EMA Substance Dictionary
We analysed the SMPC composition text and searched for the closest equivalent in EMA's published substance dictionary. The suggested match and supporting details are shown below.
SMPC composition / active substance
Matched EMA substance
EMA SMS ID
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Further information for:
Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.
OD Indication (OD)
Nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A
Full Designation Number(OD)
PLGB 24576/0009/OD1
Orphan Condition(OD)
Molybdenum cofactor deficiency Type A
All Indications (SMPC)
All Contraindications (SMPC)
Warnings/Precautions (SMPC)
Interactions (SMPC)
Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
Storage (SMPC)
Container description (SMPC)
Handling/Disposal (SMPC)
SMPC_URL