EMEA-000745-PIP01-09-M03 - paediatric investigation plan

guanfacine hydrochloride

Key facts

• Active substance:
  guanfacine hydrochloride
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0265/2013
• PIP number:
  EMEA-000745-PIP01-09-M03
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/10/2013
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000745-PIP01-09-M03
• Compliance opinion date:
  06/12/2013
• Compliance outcome:
  Positive

Decision

P/0265/2013: EMA decision of 30 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for Guanfacine (hydrochloride) (EMEA-000745-PIP01-09-M03)

Adopted Reference Number: EMA/85737/2013