Detailed SMPC and OD register data for: Imcivree
Data as extracted from Orphan Designation Register
Product (OD)
Imcivree
PL number (OD)
PLGB 55587/0001
OD Designation ID (OD)
OD1
Active substance (OD)
setmelanotide
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)
The treatment of obesity and the control of hunger associated with genetically confirmed loss of function biallelic pro-opiomelanocortin (POMC), including PCSK1 deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above
Full Designation Number(OD)
PLGB 55587/0001/OD1
Orphan Condition(OD)
Genetic obesity disorders caused by defects in melanocortin 4 receptor (MC4R) pathway, including POMC and LEPR deficiency obesity
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