EMEA-002989-PIP01-21

Table of contents

Key facts

Active substance
Leniolisib
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0556/2021
PIP number
EMEA-002989-PIP01-21
Pharmaceutical form(s)
  • Capsule, hard
  • Film-coated tablet
  • Granules
Condition(s) / indication(s)
Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)
Route(s) of administration
Oral use
Contact for public enquiries
Pharming Group N.V.
Tel. +31 715247400
E-mail: info@pharming.com
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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