EMEA-003252-PIP01-22 - paediatric investigation plan

3-(1,3-benzodioxol-5-yl)-5-(3-bromophenyl)-1H-pyrazole

Key facts

• Active Substance:
  3-(1,3-benzodioxol-5-yl)-5-(3-bromophenyl)-1H-pyrazole
• Therapeutic area:
  Neurology
• Decision number:
  P/0420/2022
• PIP number:
  EMEA-003252-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of multiple system atrophy
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Teva B.V.

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/10/2022

Decision

P/0420/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for 3-(1,3-benzodioxol-5-yl)-5-(3-bromophenyl)-1Hpyrazole (EMEA-003252-PIP01-22)

AdoptedReference Number: EMA/824970/2022