Approvals/TGA/KOMBIGLYZE XR 5/1000 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release

Approved

STANDARD

KOMBIGLYZE XR 5/1000 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release

AstraZeneca Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: fd83c7becbf6c754
Product Name: KOMBIGLYZE XR 5/1000 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release
Artg Id: 202208
Artg Name: KOMBIGLYZE XR 5/1000 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 1000 mg metformin hydrochloride modified release
Sponsor: AstraZeneca Pty Ltd
Company Detail Path: /organization/astrazeneca-pty-ltd
Artg Date: 2013-10-10
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/d0b993c88e7e08b198854593358c5e38.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/0aad235579b2b82c4e39d9181215dc88.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

fd83c7becbf6c754

Type

Standard