Approvals/TGA/JANUMET XR 50/1000 sitagliptin (as phosphate monohydrate)/metformin hydrochloride 50 mg/1000 mg extended release tablet bottle

Approved

STANDARD

JANUMET XR 50/1000 sitagliptin (as phosphate monohydrate)/metformin hydrochloride 50 mg/1000 mg extended release tablet bottle

Merck Sharp & Dohme (Australia) Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 8f552a0ec923ca26
Product Name: JANUMET XR 50/1000 sitagliptin (as phosphate monohydrate)/metformin hydrochloride 50 mg/1000 mg extended release tablet bottle
Artg Id: 205317
Artg Name: JANUMET XR 50/1000 sitagliptin (as phosphate monohydrate)/metformin hydrochloride 50 mg/1000 mg extended release tablet bottle
Sponsor: Merck Sharp & Dohme (Australia) Pty Ltd
Company Detail Path: /organization/merck-sharp-and-dohme-australia-pty-ltd
Artg Date: 2013-11-01
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/a372618ff3429851e24c37bdc7ebcd74.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/e74b7fd4230d4a537675d20c74998dd0.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 29, 2025

Approval ID

8f552a0ec923ca26

Type

Standard