MHRA-100075-PIP01-21-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • leniolisib
Invented Name
PIP Number MHRA-100075-PIP01-21-M01 (update)
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 (δ) syndrome (APDS)
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Pharming Technologies B.V.
  • Country Netherlands
  • Tel +31715247400
  • Email
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance opinion date
Compliance Check Procedure Number
Compliance procedure number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):leniolisib.pdf
Published Date 07/12/2022