MHRA-100075-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • leniolisib
Invented Name
  • Joenja
  • Joenja
  • Joenja
  • Joenja
PIP Number MHRA-100075-PIP01-21-M02 (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
Yes
Compliance Check Decision Date
Compliance opinion date
16/10/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100075-PIP01-21-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):leniolisib.pdf
Published Date 19/12/2023