Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Novartis South Africa (Pty) Ltd., Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090
GALVUS MET 50 mg/850 mg tablet.
GALVUS MET 50 mg/1 000 mg tablet.
| Pharmaceutical Form |
|---|
|
GALVUS MET 50 mg/850 mg: yellow, ovaloid bevelled edge, film-coated tablet imprinted with “NVR” on one side and “SEH” on the other side. GALVUS MET 50 mg/1 000 mg: dark yellow, ovaloid bevelled edge, film-coated tablet imprinted with “NVR” on one side and “FLO” on the other side. |
GALVUS MET 50 mg/850 mg: Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride.
GALVUS MET 50 mg/1 000 mg: Each tablet contains 50 mg vildagliptin and 1 000 mg metformin hydrochloride.
| 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. |
|
| Vildagliptin |
Vildagliptin enhances the sensitivity of beta cells to glucose, resulting in improved glucose-dependent insulin secretion by increasing the endogenous levels of these incretin hormones. The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide). |
| List of Excipients |
|---|
|
GALVUS MET 50 mg/850 mg: Hydroxypropyl cellulose, hypromellose, iron oxide yellow, magnesium stearate, polyethylene glycol, talc, titanium dioxide. GALVUS MET 50 mg/1000 mg: Hydroxypropyl cellulose, hypromellose, iron oxide yellow, magnesium stearate, polyethylene glycol, talc, titanium dioxide. |
10, 30, 60, 120, 180 or 360’s tablets in PA / AI / PVC (polyamide / aluminium / polyvinylchloride) blisters with an aluminium foil backing. Not all pack sizes may be marketed.
Novartis South Africa (Pty) Ltd., Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090
GALVUS MET 50 mg/850 mg tablet: 43/21.2/1055
GALVUS MET 50 mg/1 000 mg tablet: 43/21.2/1056
Namibia:
GALVUS MET 50 mg/850 mg: 12/21.2/0128 NS2
GALVUS MET 50 mg/1 000 mg: 12/21.2/0129 NS2
Botswana:
GALVUS MET 50 mg/850 mg: BOT1302432/A S2
GALVUS MET 50 mg/1 000 mg: BOT1302431/A S2
Date of Registration of medicine: 27 July 2012
| Drug | Countries | |
|---|---|---|
| GALVUS MET | Brazil, Hong Kong, Mexico, New Zealand, Singapore, Turkey, South Africa |
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