EMEA-000054-PIP01-07-M04 - paediatric investigation plan

pitavastatin (calcium)

Key facts

• Invented name:
  Livazo and associated names
• Active substance:
  pitavastatin (calcium)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0095/2016
• PIP number:
  EMEA-000054-PIP01-07-M04
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of disorders of lipoprotein metabolism and other lipidaemias
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/04/2016
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000054-PIP01-07-M04
• Compliance opinion date:
  19/08/2016
• Compliance outcome:
  Positive

Decision

P/0095/2016: EMA decision of 15 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for pitavastatin (calcium) (Livazo and associated names) (EMEA-000054-PIP01-07-M04)

Adopted Reference Number: EMA/195514/2016