MHRA-100075-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • leniolisib
Invented Name
  • Joenja
  • Joenja
  • Joenja
  • Joenja
PIP Number MHRA-100075-PIP01-21-M03 (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 info@pharming.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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 28/07/2025