EMEA-001547-PIP01-13 - paediatric investigation plan

atorvastatin

perindopril

acetylsalicylic acid

Key facts

• Active substance:
  • atorvastatin
  • perindopril
  • acetylsalicylic acid
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0151/2015
• PIP number:
  EMEA-001547-PIP01-13
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  • Treatment of elevated cholesterol
  • Treatment of ischemic coronary artery disorders
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/07/2015
• Compliance check done:
  No

Decision

P/0151/2015: EMA decision of 10 July 2015 on the granting of a product specific waiver for atorvastatin / perindopril / acetylsalicylic acid (EMEA-001547-PIP01-13)

Adopted Reference Number: EMA/382964/2015