Detailed SMPC and OD register data for: Myalepta
Data as extracted from Orphan Designation Register
Product (OD)
Myalepta
PL number (OD)
PLGB 08829/0215
OD Designation ID (OD)
OD1
Active substance (OD)
metreleptin
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)
Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients: with confirmed familial partial LD in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.
Full Designation Number(OD)
PLGB 08829/0215-0217/OD1
Orphan Condition(OD)
Familial Partial Lipodystrophy
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