Detailed SMPC and OD register data for: ALPROLIX
Data as extracted from Orphan Designation Register
Product (OD)
ALPROLIX
PL number (OD)
PLGB 30941/0003
OD Designation ID (OD)
OD1
Active substance (OD)
eftrenonacog alfa Recombinant fusion protein consisting of human coagulation factor IX attached to the Fc domain of human IgG1
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
Confidence
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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)
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). ALPROLIX can be used for all age groups.
Full Designation Number(OD)
PLGB 30941/0003 - 0007/OD1
Orphan Condition(OD)
Haemophilia B (congenital factor IX deficiency)
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