EMEA-001269-PIP01-12 - paediatric investigation plan

rosuvastatin

acetylsalicylic acid

Key facts

• Active substance:
  • rosuvastatin
  • acetylsalicylic acid
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0223/2012
• PIP number:
  EMEA-001269-PIP01-12
• Pharmaceutical form(s):
  • Film-coated tablet
  • Gastro-resistant tablet
• Condition(s) / indication(s):
  Treatment of cardiovascular disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/10/2012
• Compliance check done:
  Ne

Decision

P/0223/2012: EMA decision of 1 October 2012 on the granting of a product specific waiver for rosuvastatin / acetylsalicylic acid (EMEA-001269-PIP01- 12)

Adopted Reference Number: EMA/559169/2012