Detailed SMPC and OD register data for: ALYFTREK
Data as extracted from Orphan Designation Register
Product (OD)
ALYFTREK
PL number (OD)
PL 22352/0024
OD Designation ID (OD)
OD1
Active substance (OD)
TEZACAFTOR, DEUTIVACAFTOR, VANZACAFTOR CALCIUM DIHYDRATE
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)
Alyftrek 50mg/20mg/4mg & 125mg/50mg/10mg film-coated tablets for the treatment of cystic fibrosis (CF) in people aged 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Full Designation Number(OD)
PL 22352/0024-25/OD1
Orphan Condition(OD)
Orphan condition: cystic fibrosis (CF)
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