Detailed SMPC and OD register data for: Gilteritinib Astellas 40mg film-coated tablets
Data as extracted from Orphan Designation Register
Product (OD)
Gilteritinib Astellas 40mg film-coated tablets
PL number (OD)
PLGB 00166/0425
OD Designation ID (OD)
OD1
Active substance (OD)
gilteritinib
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)
Gilteritinib Astellas is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.
Full Designation Number(OD)
PLGB 00166/0425/OD1
Orphan Condition(OD)
Acute myeloid leukaemia
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)
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