EMEA-003189-PIP01-22-M01 - paediatric investigation plan

Methylphenidate (hydrochloride)

Key facts

• Active substance:
  Methylphenidate (hydrochloride)
• Therapeutic area:
  Neurology
• Decision number:
  P/0057/2023
• PIP number:
  EMEA-003189-PIP01-22-M01
• Pharmaceutical form(s):
  • Chewable tablet
  • Oral suspension
• 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:
  24/01/2023
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-003189-PIP01-22-M01
• Compliance opinion date:
  02/02/2023
• Compliance outcome:
  Positive

Decision

P/0057/2023 : EMA decision of 24 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for methylphenidate (hydrochloride) (EMEA-003189-PIP01-22-M01)

Adopted Reference Number: EMA/21175/2023