Israel - English - Ministry of Health

abir therapeutics ltd, israel - naloxegol as oxalate - film coated tablets - naloxegol as oxalate 25 mg - naloxegol - moventig is indicated for the treatment of opioid-induced constipation (oic) in adult patients who have had an inadequate response to laxative(s).

Israel - English - Ministry of Health

abir therapeutics ltd, israel - naloxegol as oxalate - film coated tablets - naloxegol as oxalate 25 mg - naloxegol - moventig is indicated for the treatment of opioid-induced constipation (oic) in adult patients who have had an inadequate response to laxative(s).

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - florfenicol; mometasone furoate; terbinafine hydrochloride - topical soln & aural,opthal,oro - florfenicol antibiotic active 16.7 mg/ml; mometasone furoate adrenocorticoid-synthetic active 2.2 mg/ml; terbinafine hydrochloride active 14.8 mg/ml - dermatological preps.

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dapagliflozin - film-coated tablet - dapagliflozin

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dapagliflozin - film-coated tablet - dapagliflozin

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanediol monohydrate, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - type 2 diabetes mellitusfor the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.as monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.for study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.type 1 diabetes mellitusedistride is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with bmi ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab  - metformin hydrochloride, saxagliptin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - metformin hydrochloride, dapagliflozin propanediol monohydrate - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:•    in patients insufficiently controlled on their maximally tolerated dose of metformin alone •    in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products•    in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.for study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - metformin hydrochloride - tablet - 850mg

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - rivaroxaban - film-coated tablet - 10 milligram(s) - rivaroxaban