Approvals/TGA/SIMIPEX XR pramipexole dihydrochloride monohydrate 0.75 mg modified release tablet blister pacl

Approved

STANDARD

SIMIPEX XR pramipexole dihydrochloride monohydrate 0.75 mg modified release tablet blister pacl

Arrotex Pharmaceuticals Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 55b0fb6a74aa3b58
Product Name: SIMIPEX XR pramipexole dihydrochloride monohydrate 0.75 mg modified release tablet blister pacl
Artg Id: 225573
Artg Name: SIMIPEX XR pramipexole dihydrochloride monohydrate 0.75 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: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022-CMI-02477-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022-PI-02476-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

55b0fb6a74aa3b58

Type

Standard