EMEA-003010-PIP01-21 - paediatric investigation plan

Sivopixant

Key facts

• Active Substance:
  Sivopixant
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0326/2021
• PIP number:
  EMEA-003010-PIP01-21
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of unexplained or refractory chronic cough
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/08/2021

Decision

P/0326/2021 : EMA decision of 13 August 2021 on the granting of a product specific waiver for sivopixant (EMEA-003010-PIP01-21)

AdoptedReference Number: EMA/384970/2021