MHRA-100106-PIP01-21

Key Facts

PIPS Key Facts
Active Substance
  • 3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxaminde
  • sodium chloride solution 4.2% (w/v)
Invented Name
Not yet available
PIP Number MHRA-100106-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Inhalation solution
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of primary ciliary dyskinesia
Route(s) of administration
Route(s) of administration:
  • Inhalation use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxaminde;sodium chloride solution 4.2% (w/v).pdf
Published Date 17/05/2022