Estados Unidos - inglês - NLM (National Library of Medicine)

amneal pharmaceuticals llc - saxagliptin hydrochloride (unii: z8j84yix6l) (saxagliptin anhydrous - unii:8i7io46ivq) - saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies (14) ]. saxagliptin tablets are not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. saxagliptin tablets are contraindicated in patients with a history of a serious hypersensitivity reaction to saxagliptin, such as anaphylaxis, angioedema, or exfoliative skin conditions [see warnings and precautions (5.4)  and adverse reactions (6.2) ]. risk summary limited data with saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriages. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . no adverse developmental effects independent of maternal toxicity were observed when saxagliptin was administered to pregnant rats and rabbits during the period

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

astrazeneca limited - saxagliptin hydrochloride 2.98mg equivalent to saxagliptin 2.5 mg - film coated tablet - 2.5 mg - active: saxagliptin hydrochloride 2.98mg equivalent to saxagliptin 2.5 mg excipient: croscarmellose sodium hydrochloric acid lactose monohydrate magnesium stearate microcrystalline cellulose opacode blue s-1-10619 opadry ii yellow 85f92209 opadry white 85f18422 purified water - onglyza is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

astrazeneca limited - saxagliptin hydrochloride 5.95mg equivalent to saxagliptin 5 mg - film coated tablet - 5 mg - active: saxagliptin hydrochloride 5.95mg equivalent to saxagliptin 5 mg excipient: croscarmellose sodium hydrochloric acid lactose monohydrate magnesium stearate microcrystalline cellulose opacode blue s-1-4118 opadry pink 85f14452 opadry white 85f18422 purified water - onglyza is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Malásia - inglês - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - metformin hydrochloride; saxagliptin hydrochloride -

Malásia - inglês - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - metformin hydrochloride; saxagliptin hydrochloride -

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - saxagliptin hydrochloride - tablet - 5mg

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - saxagliptin hydrochloride - tablet - 2.5mg

Malásia - inglês - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - saxagliptin hydrochloride; dapagliflozin propanediol -

Israel - inglês - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin as propanediol; saxagliptin as hydrochloride monohydrate - film coated tablets - dapagliflozin as propanediol 10 mg; saxagliptin as hydrochloride monohydrate 5 mg - saxagliptin and dapagliflozin - qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:- to improve glycaemic control when metformin and/or sulphonylurea (su) and one of the monocomponents of qtern do not provide adequate glycaemic control,- when already being treated with the free combination of dapagliflozin and saxagliptin.

Israel - inglês - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin as propanediol; saxagliptin as hydrochloride monohydrate - film coated tablets - dapagliflozin as propanediol 10 mg; saxagliptin as hydrochloride monohydrate 5 mg - saxagliptin and dapagliflozin - qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:- to improve glycaemic control when metformin and/or sulphonylurea (su) and one of the monocomponents of qtern do not provide adequate glycaemic control,- when already being treated with the free combination of dapagliflozin and saxagliptin.