MHRA-100106-PIP01-21

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

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