MHRA-100075-PIP01-21

Key Facts

Active Substance
Active Substance:
  • leniolisib
Invented Name
Not available at present
PIP Number MHRA-100075-PIP01-21
Pharmaceutical form(s)
  • Film-coated tablet
  • Capsule, hard
  • Granules
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)
Route(s) of administration
Route(s) of administration:
  • Oral 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):leniolisib.pdf
Published Date 02/11/2022