EMEA-003228-PIP01-22 - paediatric investigation plan

rosuvastatin

perindopril

Key facts

• Active substance:
  • rosuvastatin
  • perindopril
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0376/2022
• PIP number:
  EMEA-003228-PIP01-22
• Pharmaceutical form(s):
  Film-coated dispersible tablet
• Condition(s) / indication(s):
  • Prevention of cardiovascular events
  • Treatment of dyslipidaemia
  • Treatment of hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/09/2022
• Compliance check done:
  No

Decision

P/0376/2022: EMA decision of 19 September 2022 on the granting of a product specific waiver for rosuvastatin (calcium) / perindopril (tert-butylamin) (EMEA-003228-PIP01-22)

Reference Number: EMA/706940/2022