01 2Centocor
02 19GSK
03 4Janssen-Cilag
04 2Johnson & Johnson Innovative Medicine
01 1CAPSULE;ORAL
02 1Capsule
03 2FCT
04 6Film Coated Tablet
05 1Hard Capsule
06 3TABLET
07 3TABLET;ORAL
08 2Tablet, film-coated
09 8Blank
01 4Allowed
02 4Authorized
03 1DISCN
04 2Originator
05 3Prescription
06 3RX
07 10Blank
01 2AKEEGA
02 1AKEEGA 100 mg /500 mg
03 1AKEEGA 50 mg /500 mg
04 2Akeega
05 2Akeega mg
06 5ZEJULA
07 13Zejula
08 1Zejula capsules
01 8Australia
02 3Canada
03 2Norway
04 2South Africa
05 4Spain
06 4Switzerland
07 4USA
Regulatory Info : Prescription
Registration Country : Canada
NIRAPARIB (NIRAPARIB TOSYLATE)
Brand Name : AKEEGA
Dosage Form : TABLET
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number : 2538555
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
NIRAPARIB (NIRAPARIB TOSYLATE)
Brand Name : AKEEGA
Dosage Form : TABLET
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 2538563
Regulatory Info : Prescription
Registration Country : Canada
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 : Authorized
Registration Country : Spain
Niraparib Tosylate Monohydrate
Brand Name : Zejula
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date : 2024-04-12
Application Number : 1171235006
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Niraparib Tosylate Monohydrate
Brand Name : Zejula
Dosage Form : Hard Capsule
Dosage Strength : 100MG
Packaging :
Approval Date : 2018-03-08
Application Number : 1171235001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Prescription
Registration Country : Canada
NIRAPARIB (NIRAPARIB TOSYLATE)
Brand Name : ZEJULA
Dosage Form : TABLET
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 2530031
Regulatory Info : Prescription
Registration Country : Canada
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 : 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 : Authorized
Registration Country : Spain
Abiraterone Acetate; Niraparib Tosylate Monohydrate
Brand Name : Akeega
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG; 500 MG
Packaging :
Approval Date : 2023-04-27
Application Number : 1231722002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Abiraterone Acetate; Niraparib Tosylate Monohydrate
Brand Name : Akeega
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG; 500 MG
Packaging :
Approval Date : 2023-04-27
Application Number : 1231722001
Regulatory Info : Authorized
Registration Country : Spain
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
