EMEA-000553-PIP01-09-M05 - paediatric investigation plan

Lisdexamfetamine dimesilate

Key facts

• Invented name:
  Elvanse and associated names
• Active substance:
  Lisdexamfetamine dimesilate
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0097/2022
• PIP number:
  EMEA-000553-PIP01-09-M05
• Pharmaceutical form(s):
  Capsule, hard
• 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:
  17/03/2022
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-000553-PIP01-09-M05
• Compliance opinion date:
  25/05/2022
• Compliance outcome:
  Positive

Decision

P/0097/2022 : EMA decision of 17 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lisdexamfetamine (dimesylate), (Elvanse and associated names), (EMEA-000553-PIP01-09-M05)

Adopted Reference Number: EMA/145463/2022