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Detailed SMPC and OD register data for: AMGLIDIA

Data as extracted from Orphan Designation Register

Product (OD)
AMGLIDIA
PL number (OD)
PLGB 50687/0001
OD Designation ID (OD)
OD1
Active substance (OD)
Glibenclamide

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)

IDMP View

Structured regulatory data for this product mapped to the IDMP entity hierarchy (ISO 11615) — Marketing Authorisation, Medicinal Product, and Administrable Product.
Note: Wherever a type is listed as "Equivalent Term not known", we dont have the information available in public domain. However, this data is usually available in eAF (or equivalent) form and is stored by most regulators as strucutured data - albeit not always in same hierarchy as IDMP.

No IDMP data is linked to this authorisation number.

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

FDA Approved Products —

Products approved by the FDA containing the matched EMA substance, sourced from OpenFDA Drugs@FDA.

No EMA substance match available — FDA lookup skipped.

Further information for:

Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.

OD Indication (OD)
AMGLIDIA is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children. Sulphonylureas like AMGLIDIA have been shown to be effective in patients with mutations in the genes coding for the ?-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.
Full Designation Number(OD)
PLGB 50687/0001 - 0004/OD1
Orphan Condition(OD)
Neonatal diabetes
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