
Reset all filters
01 18GSK
02 4Janssen-Cilag
03 2Johnson & Johnson Innovative Medicine
Reset all filters
01 1CAPSULE;ORAL
02 1Capsule
03 2FCT
04 6Film Coated Tablet
05 1Hard Capsule
06 3TABLET;ORAL
07 2Tablet, film-coated
08 8Blank
Reset all filters
01 4Allowed
02 4Authorized
03 1DISCN
04 2Originator
05 3RX
06 10Blank
Reset all filters
01 1AKEEGA 100 mg /500 mg
02 1AKEEGA 50 mg /500 mg
03 2Akeega
04 2Akeega mg
05 4ZEJULA
06 13Zejula
07 1Zejula capsules
Reset all filters
01 8Australia
02 2Norway
03 2South Africa
04 4Spain
05 4Switzerland
06 4USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ZEJULA
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2017-03-27
Application Number : 208447
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEJULA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2023-04-26
Application Number : 214876
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEJULA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 200MG BASE
Packaging :
Approval Date : 2023-04-26
Application Number : 214876
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEJULA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 300MG BASE
Packaging :
Approval Date : 2023-04-26
Application Number : 214876
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Zejula
Dosage Form : Tablet, film-coated
Dosage Strength : 100 mg
Packaging : Blisterpakning 56item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Zejula
Dosage Form : Tablet, film-coated
Dosage Strength : 100 mg
Packaging : Blisterpakning 84item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Zejula capsules
Dosage Form : Capsule
Dosage Strength : 100mg
Packaging :
Approval Date : 03/10/2018
Application Number : 66763
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Zejula
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 20/01/2023
Application Number : 68652
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Zejula
Dosage Form :
Dosage Strength :
Packaging : 84
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Allowed
Registration Country : Switzerland
Niraparib; Abiraterone Acetate
Brand Name : Akeega mg
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg;500mg
Packaging :
Approval Date : 18/04/2024
Application Number : 68977
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Niraparib; Abiraterone Acetate
Brand Name : Akeega mg
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg;500mg
Packaging :
Approval Date : 18/04/2024
Application Number : 68977
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : AKEEGA 50 mg /500 mg
Dosage Form : FCT
Dosage Strength : 50mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : AKEEGA 100 mg /500 mg
Dosage Form : FCT
Dosage Strength : 100mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa