Approvals/TGA/SIMIPEX XR pramipexole dihydrochloride monohydrate 0.375 mg modified release tablet blister pack

Approved

STANDARD

SIMIPEX XR pramipexole dihydrochloride monohydrate 0.375 mg modified release tablet blister pack

Arrotex Pharmaceuticals Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 7eb7f2b2f4c2f65d
Product Name: SIMIPEX XR pramipexole dihydrochloride monohydrate 0.375 mg modified release tablet blister pack
Artg Id: 225592
Artg Name: SIMIPEX XR 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: 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

7eb7f2b2f4c2f65d

Type

Standard