Detailed SMPC and OD register data for: Casgevy
Data as extracted from Orphan Designation Register
Product (OD)
Casgevy
PL number (OD)
PLGB 22352/0019
OD Designation ID (OD)
OD2
Active substance (OD)
autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene
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 sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises who have the ?S/?S, ?S/?+ or ?S/?0 genotype, for whom a haematopoeitic stem cell transplantation is appropriate and a human leukocyte antigen matched related haematopoietic stem cell donor is not available.
Full Designation Number(OD)
PLGB 22352/0019/OD2
Orphan Condition(OD)
sickle cell disease
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