MHRA-101489-PIP01-24-M02 (update)

Key Facts

Active Substance
Active Substance:
  • Enlicitide (decanoate)
Invented Name
Not yet available
PIP Number MHRA-101489-PIP01-24-M02 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate formulation
  • Film-coated tablet
  • Age-appropriate formulation
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of lipid disorders
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
29/01/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101489-PIP01-24-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Enlicitide (decanoate).pdf
Published Date 16/07/2026