Detailed SMPC and OD register data for: Hemgenix 1 x 10^13 genome copies/mL concentrate for solution for infusion
Data as extracted from Orphan Designation Register
Product (OD)
Hemgenix 1 x 10^13 genome copies/mL concentrate for solution for infusion
PL number (OD)
PLGB 15036/0160
OD Designation ID (OD)
OD1
Active substance (OD)
ETRANACOGENE DEZAPARVOVEC
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
Higher confidence means the match is more likely to be correct.
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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 of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors.
Full Designation Number(OD)
PLGB 15036/0160/OD1
Orphan Condition(OD)
Haemophilia B (Factor IX)
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