Detailed SMPC and OD register data for: Kalydeco
Data as extracted from Orphan Designation Register
Product (OD)
Kalydeco
PL number (OD)
PLGB 22352/0008
OD Designation ID (OD)
OD1
Active substance (OD)
ivacaftor N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide
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 cystic fibrosis (CF) in patients age six years and older who have a G551D mutation in the CFTR gene
Full Designation Number(OD)
PLGB 22352/0008 - 0011/OD1
Orphan Condition(OD)
Cystic fibrosis
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