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2 Information about leniolisib

Marketing authorisation indication

2.1

Leniolisib (Joenja, Pharming) is indicated for 'the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and paediatric patients 12 years of age and older'.

Dosage in the marketing authorisation

Price

2.3

The list price for leniolisib is commercial in confidence.

2.4

The company has a commercial arrangement, which would have applied if the leniolisib had been recommended.