Detailed SMPC and OD register data for: Ezmekly
Data as extracted from Orphan Designation Register
Product (OD)
Ezmekly
PL number (OD)
PL 59369/0003
OD Designation ID (OD)
OD1
Active substance (OD)
mirdametinib
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)
symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with NF1 aged 2 years and above
Full Designation Number(OD)
PL 59369/0003-0005/OD1
Orphan Condition(OD)
neurofibromatosis type 1 (NF1)
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