Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Janumet 50 mg/850 mg film-coated tablets.
Janumet 50 mg/1,000 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Janumet 50 mg/850 mg film-coated tablets: Capsule-shaped, pink film-coated tablet with “515” debossed on one side. Janumet 50 mg/1,000 mg film-coated tablets: Capsule-shaped, red film-coated tablet with “577” debossed on one side. |
Janumet 50 mg/850 mg film-coated tablets: Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
Janumet 50 mg/1,000 mg film-coated tablets: Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Metformin |
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. |
|
| Metformin and Sitagliptin |
Combination of two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class. |
|
| Sitagliptin |
Sitagliptin is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors. The improvement in glycaemic control observed with this medicinal product may be mediated by enhancing the levels of active incretin hormones. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460) Film coating: Poly(vinyl alcohol) |
Opaque blisters (PVC/PE/PVDC and aluminium). Packs of 14, 28, 56, 60, 112, 168, 180, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) and 168 (2 packs of 84) film-coated tablets. Pack of 50 × 1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Janumet 50 mg/850 mg film-coated tablets:
EU/1/08/455/001
EU/1/08/455/002
EU/1/08/455/003
EU/1/08/455/004
EU/1/08/455/005
EU/1/08/455/006
EU/1/08/455/007
EU/1/08/455/015
EU/1/08/455/017
EU/1/08/455/019
EU/1/08/455/020
Janumet 50 mg/1,000 mg film-coated tablets:
EU/1/08/455/008
EU/1/08/455/009
EU/1/08/455/010
EU/1/08/455/011
EU/1/08/455/012
EU/1/08/455/013
EU/1/08/455/014
EU/1/08/455/016
EU/1/08/455/018
EU/1/08/455/021
EU/1/08/455/022
Date of first authorisation: 16 July 2008
Date of latest renewal: 13 March 2013
| Drug | Countries | |
|---|---|---|
| JANUMET | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
