Detailed SMPC and OD register data for: Fintepla
Data as extracted from Orphan Designation Register
Product (OD)
Fintepla
PL number (OD)
PLGB 00039/0804
OD Designation ID (OD)
OD1
Active substance (OD)
fenfluramine
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.
Show AI rationale
Further information for:
Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.
OD Indication (OD)
Fintepla is indicated for the treatment of seizures associated with Dravet syndrome as an add on therapy to other anti-epileptic medicines for patients 2 years of age and older.
Full Designation Number(OD)
PLGB 00039/0804/OD1
Orphan Condition(OD)
Dravet syndrome
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