Approvals/TGA/ZEJULA niraparib (as tosilate monohydrate) 100 mg film-coated tablet blister pack

Approved

STANDARD

ZEJULA niraparib (as tosilate monohydrate) 100 mg film-coated tablet blister pack

GlaxoSmithKline Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: d54c0aa614f8be52
Product Name: ZEJULA niraparib (as tosilate monohydrate) 100 mg film-coated tablet blister pack
Artg Id: 395406
Artg Name: ZEJULA niraparib (as tosilate monohydrate) 100 mg film-coated tablet blister pack
Sponsor: GlaxoSmithKline Australia Pty Ltd
Company Detail Path: /organization/glaxosmithkline-australia-pty-ltd
Artg Date: 2023-08-02
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/17e3c8b8f0d8319becdefb3f25d02f7d.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/3e5f19e39ed2e61f282cf5020e3fe0e0.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

d54c0aa614f8be52

Type

Standard