Approvals/TGA/SIMIPEX XR pramipexole dihydrochloride monohydrate 3.75 mg modified release tablet blister pack

Approved

STANDARD

SIMIPEX XR pramipexole dihydrochloride monohydrate 3.75 mg modified release tablet blister pack

Arrotex Pharmaceuticals Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: c8d90dc594fda710
Product Name: SIMIPEX XR pramipexole dihydrochloride monohydrate 3.75 mg modified release tablet blister pack
Artg Id: 225578
Artg Name: SIMIPEX XR pramipexole dihydrochloride monohydrate 3.75 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/aab3c64bcee3c5611322d00c626c73dc.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/ecdf64c22af43436c0659adc5a6b8ed8.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

c8d90dc594fda710

Type

Standard