Detailed SMPC and OD register data for: Wakix 4.5 mg Film-coated Tablets
Data as extracted from Orphan Designation Register
Product (OD)
Wakix 4.5 mg Film-coated Tablets
PL number (OD)
PLGB 18813/0007
OD Designation ID (OD)
OD1
Active substance (OD)
PITOLISANT HYDROCHLORIDE
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)
Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy
Full Designation Number(OD)
PLGB 18813/0007/OD1
Orphan Condition(OD)
Narcolepsy
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