Rosuvastatin (calcium) - paediatric investigation plan

rosuvastatin calcium

Key facts

• Invented name:
  Crestor and associated names
• Active substance:
  rosuvastatin calcium
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/229/2010
• PIP number:
  Rosuvastatin (calcium)
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Homozygous Familial Hypercholesterolaemia
  • Prevention of cardiovascular events
  • Primary combined (mixed) dyslipidaemia
  • Primary hypercholesterolaemia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/11/2010
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000022-PIP01-07-M04
• Compliance opinion date:
  11/10/2013
• Compliance outcome:
  Positive

Decision

P/229/2010: EMA decision of 23 November 2010 on the acceptance of a modification of an agreed paediatric investigation plan for rosuvastatin (calcium) (Crestor and associated names) (EMEA-000022-PIP01-07-M04)

Adopted Reference Number: EMA/714398/2010