Approvals/TGA/APO-PRAMIPEXOLE ER pramipexole dihydrochloride monohydrate 0.375 mg modified release tablet blister pack

Approved

STANDARD

APO-PRAMIPEXOLE ER pramipexole dihydrochloride monohydrate 0.375 mg modified release tablet blister pack

Arrotex Pharmaceuticals Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 106efe077f056260
Product Name: APO-PRAMIPEXOLE ER pramipexole dihydrochloride monohydrate 0.375 mg modified release tablet blister pack
Artg Id: 225622
Artg Name: APO-PRAMIPEXOLE ER pramipexole dihydrochloride monohydrate 0.375 mg modified release tablet blister pack
Sponsor: Arrotex Pharmaceuticals Pty Ltd
Company Detail Path: /organization/arrotex-pharmaceuticals-pty-ltd
Artg Date: 2015-06-17
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/d3504263b1976e331f41e846c49df17b.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/f4d507e724e0f9d3be4f04ed2c9ffced.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

106efe077f056260

Type

Standard