Malta - English - Medicines Authority

egis pharmaceuticals plc kereszturi ut 30-38 1106 budapest, hungary - vildagliptin, metformin hydrochloride - film-coated tablet - metformin hydrochloride 850 mg vildagliptin 50 mg - drugs used in diabetes

Malta - English - Medicines Authority

bennett pharmaceuticals sa 16th km athinon-lamias kifisia 14564,, greece - vildagliptin, metformin hydrochloride - film-coated tablet - metformin hydrochloride 1000 mg vildagliptin 50 mg - drugs used in diabetes

Australia - English - Department of Health (Therapeutic Goods Administration)

actavis pty ltd - metformin hydrochloride -

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - metformin hydrochloride 1000mg;  ; saxagliptin 2.5mg (as saxagliptin hydrochloride) - modified release tablet - 2.5mg/1000mg - active: metformin hydrochloride 1000mg   saxagliptin 2.5mg (as saxagliptin hydrochloride) excipient: carmellose sodium hydrochloric acid   hypromellose magnesium stearate opacode blue s-1-10619 opadry ii yellow 85f92209 opadry white 85f18422 purified water     - kombiglyze xr is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - metformin hydrochloride 1000mg;  ; saxagliptin 5mg (as saxagliptin hydrochloride) - modified release tablet - 5mg/1000mg - active: metformin hydrochloride 1000mg   saxagliptin 5mg (as saxagliptin hydrochloride) excipient: carmellose sodium hydrochloric acid hypromellose magnesium stearate opacode blue s-1-10619 opadry pink 85f14452 opadry white 85f18422 purified water     - kombiglyze xr is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - metformin hydrochloride 500mg;  ; saxagliptin 5mg (as saxagliptin hydrochloride) - modified release tablet - 5mg/500mg - active: metformin hydrochloride 500mg   saxagliptin 5mg (as saxagliptin hydrochloride) excipient: carmellose sodium hydrochloric acid   hypromellose magnesium stearate microcrystalline cellulose opacode blue s-1-10619 opadry butterscotch 85f17417 opadry white 85f18422 purified water     - kombiglyze xr is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.

Malta - English - Medicines Authority

galenicum health, s.l.u calle sant gabriel, 50 esplugues de llobregat 08950 barcelona, spain - film-coated tablet - vildagliptin 50 mg metformin hydrochloride 850 mg - drugs used in diabetes

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - metformin hydrochloride -

Australia - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - metformin hydrochloride -

Israel - English - Ministry of Health

novartis israel ltd - metformin hydrochloride; vildagliptin - film coated tablets - metformin hydrochloride 1000 mg; vildagliptin 50 mg - metformin - eucreas is indicated in the treatment of type 2 diabetes mellitus:- eucreas is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.- eucreas is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulphonylurea.- eucreas is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.