MHRA-100194-PIP01-21

Key Facts

Active Substance
Active Substance:
  • sivopixant
Invented Name
Not yet available
PIP Number MHRA-100194-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of unexplained or refractory chronic cough
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):sivopixant.pdf
Published Date 19/05/2022