MHRA-100818-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • BEMPEDOIC ACID
Invented Name
  • Nilemdo® (bempedoic acid) tablets
  • Nilemdo® (bempedoic acid) film-coated tablets
  • Nilemdo® (bempedoic acid) film-coated tablets
  • Nexletol® (bempedoic acid) tablets
  • Nilemdo®
  • Nilemdo®
  • Nilemdo®
  • Nexletol®
  • Nilemdo®
PIP Number MHRA-100818-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral liquid formulation
  • Age-appropriate oral solid formulation.
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of elevated cholesterol
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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BEMPEDOIC ACID.pdf
Published Date 19/12/2023