EMEA-002366-PIP01-18 - paediatric investigation plan

acetylsalicylic acid

indapamide (hemihydrate)

perindopril tert-butylamine

rosuvastatin calcium

Key facts

• Active substance:
  • acetylsalicylic acid
  • indapamide (hemihydrate)
  • perindopril tert-butylamine
  • rosuvastatin calcium
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0311/2018
• PIP number:
  EMEA-002366-PIP01-18
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Prevention of cardiovascular events
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/09/2018
• Compliance check done:
  No

Decision

P/0311/2018: EMA decision of 12 September 2018 on the granting of a product specific waiver for acetylsalicylic acid / rosuvastatin (calcium) / perindopril (tert-butylamine) / indapamide (hemihydrate) (EMEA-002366-PIP01-18)

Reference Number: EMA/539588/2018