Atorvastatin calcium - paediatric investigation plan

Atorvastatin calcium

Key facts

• Invented name:
  Sortis and associated names
• Active Substance:
  Atorvastatin calcium
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/53/2008
• PIP number:
  Atorvastatin calcium
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral formulation
• Condition(s) / indication(s):
  Pure hypercholesterolaemia (heterozygous, homozygous, or otherwise primary hypercholesterolaemia), combined (mixed) hyperlipidaemia; prevention of cardiovascular events
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  20/07/2008
• Compliance procedure number:
  EMEA-C-000073-PIP01-07
• Compliance opinion date:
  13/11/2009
• Compliance outcome:
  Positive

Decision

P/53/2008: European medicines agency decision of 20 July 2008 on the application for agreement of a Paediatric Investigation Plan for Atorvastatin calcium (Sortis and associated names) EMEA-000073-PIP01-07 in accordance ...

AdoptedReference Number: EMEA/357907/2008