Approvals/TGA/ARX-Oxycodone/Naloxone oxycodone hydrochloride / naloxone hydrochloride 20/10 mg modified release tablets blister pack

Approved

STANDARD

ARX-Oxycodone/Naloxone oxycodone hydrochloride / naloxone hydrochloride 20/10 mg modified release tablets blister pack

Mundipharma Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: c3729b0629a82396
Product Name: ARX-Oxycodone/Naloxone oxycodone hydrochloride / naloxone hydrochloride 20/10 mg modified release tablets blister pack
Artg Id: 446592
Artg Name: ARX-Oxycodone/Naloxone oxycodone hydrochloride / naloxone hydrochloride 20/10 mg modified release tablets blister pack
Sponsor: Mundipharma Pty Ltd
Company Detail Path: /organization/mundipharma-pty-ltd
Artg Date: 2024-10-08
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-2025-CMI-01374-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2024-PI-02715-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

c3729b0629a82396

Type

Standard