EMEA-001914-PIP01-15 - paediatric investigation plan

Olmesartan medoxomil

rosuvastatin calcium

Key facts

• Active Substance:
  • Olmesartan medoxomil
  • rosuvastatin calcium
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0166/2016
• PIP number:
  EMEA-001914-PIP01-15
• Pharmaceutical form(s):
  Film-coated 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:
  15/06/2016

Decision

P/0166/2016: EMA decision of 15 June 2016 on the granting of a product specific waiver for olmesartan (medoxomil) / rosuvastatin (calcium) (EMEA-001914-PIP01-15)

AdoptedReference Number: EMA/314198/2016