MHRA Data Portal — Proof of Concept
← Back to Orphan Designations

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)
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 Bardet-Biedl syndrome (BBS) in adults and children 2 years of age and above
Full Designation Number(OD)
PLGB 55587/0001OD2
Orphan Condition(OD)
Bardet-Biedl syndrome (BBS)
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

Link to SMPC: Not available