EMEA-003198-PIP01-22 - paediatric investigation plan

Clonidine

Key facts

• Active Substance:
  Clonidine
• Therapeutic area:
  Neurology
• Decision number:
  P/0202/2022
• PIP number:
  EMEA-003198-PIP01-22
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Proveca Pharma Ltd

  E-Mail: [e-mail]

  Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/06/2022

Decision

P/0202/2022 : EMA decision of 10 June 2022 on the refusal of a paediatric investigation plan and on the granting of a waiver for clonidine (EMEA-003198-PIP01-22)

Reference Number: EMA/266803/2022