MHRA-102273-PIP01-25

Key Facts

Active Substance
  • EZETIMIBE
  • ATORVASTATIN
Invented Name
  • Ezetimibe/Atorvastatin 10mg/10mg Film-coated Tablets
  • Ezetimibe/Atorvastatin 10mg/20mg Film-coated Tablets
  • Ezetimibe/Atorvastatin 10mg/40mg Film-coated Tablets
  • Ezetimibe/Atorvastatin 10mg/80mg Film-coated Tablets
PIP Number MHRA-102273-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablets
Therapeutic area
Therapeutic area:
  • Cardiovascular Diseases
Conditions / Indications
  • Treatment of hypercholesterolaemia
  • Prevention of cardiovascular events
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
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):EZETIMIBEATORVASTATIN.pdf
Published Date 04/03/2026