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KOMBIGLYZE XR 5/500 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 500 mg metformin hydrochloride modified release - TGA Drug Approval Details
Approvals
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TGA
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KOMBIGLYZE XR 5/500 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 500 mg metformin hydrochloride modified release
Approved
STANDARD
KOMBIGLYZE XR 5/500 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 500 mg metformin hydrochloride modified release
AstraZeneca Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 29, 2025
Approval ID
e45d25196952f2fa
Company
AstraZeneca Pty Ltd
Type
Standard
Approval Details
Approval Id
e45d25196952f2fa
Product Name
KOMBIGLYZE XR 5/500 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 500 mg metformin hydrochloride modified release
Artg Id
202209
Artg Name
KOMBIGLYZE XR 5/500 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 500 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
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 29, 2025
Approval ID
e45d25196952f2fa
Type
Standard
Back to TGA Approvals