Detailed SMPC and OD register data for: Zynteglo
Data as extracted from Orphan Designation Register
Product (OD)
Zynteglo
PL number (OD)
PLGB 51370/0001
OD Designation ID (OD)
OD1
Active substance (OD)
betibeglogene autotemcel
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)
Zynteglo is indicated for the treatment of patients 12 years and older with transfusion dependent ? thalassaemia (TDT) who do not have a ?0/?0 genotype, for whom haematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA) matched related HSC donor is not available
Full Designation Number(OD)
PLGB 51370/0001/OD1
Orphan Condition(OD)
Beta-thalassaemia intermedia and major
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