EMEA-003262-PIP01-22 - paediatric investigation plan

rosuvastatin calcium

telmisartan

Key facts

• Active substance:
  • rosuvastatin calcium
  • telmisartan
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0460/2022
• PIP number:
  EMEA-003262-PIP01-22
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Prevention of cardiovascular events
  • 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:
  28/10/2022
• Compliance check done:
  No

Decision

P/0460/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for telmisartan / rosuvastatin (calcium) (EMEA-003262- PIP01-22)

Adopted Reference Number: EMA/790490/2022