EMEA-000994-PIP01-10-M01 - paediatric investigation plan

Gadobutrol

Key facts

• Invented name:
  Gadovist
• Active substance:
  Gadobutrol
• Therapeutic area:
  Diagnostic
• Decision number:
  P/0311/2013
• PIP number:
  EMEA-000994-PIP01-10-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Diagnostic evaluation of tissue pathologies with contrast-enhanced magnetic resonance imaging (MRI)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/12/2012
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000994-PIP01-10-M01
• Compliance opinion date:
  20/06/2014
• Compliance outcome:
  Positive

Decision

P/311/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for gadobutrol (Gadovist) (EMEA-000994-PIP01-10-M01)

Adopted Reference Number: EMA/722479/2013