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

pharmacor pty ltd - sitagliptin hydrochloride monohydrate, quantity: 27.25 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: sodium stearylfumarate; croscarmellose sodium; povidone; microcrystalline cellulose; calcium hydrogen phosphate dihydrate; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - pharmacor sitagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,- monotherapy when metformin is considered inappropriate due to intolerance; or,- in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies].

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

pharmacor pty ltd - sitagliptin hydrochloride monohydrate, quantity: 109 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; magnesium stearate; sodium stearylfumarate; povidone; calcium hydrogen phosphate dihydrate; croscarmellose sodium; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - sitaglo is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,- monotherapy when metformin is considered inappropriate due to intolerance; or,- in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies].

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

pharmacor pty ltd - sitagliptin hydrochloride monohydrate, quantity: 109 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: sodium stearylfumarate; magnesium stearate; povidone; croscarmellose sodium; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - pharmacor sitagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,- monotherapy when metformin is considered inappropriate due to intolerance; or,- in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies].

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

generic health pty ltd - ibuprofen, quantity: 200 mg; paracetamol, quantity: 500 mg - tablet, film coated - excipient ingredients: hypromellose; crospovidone; pregelatinised maize starch; titanium dioxide; microcrystalline cellulose; colloidal anhydrous silica; purified talc; magnesium stearate; povidone; purified water; polysorbate 80; polyvinyl alcohol; macrogol 3350; mica - temporary relief of acute (short term) pain and / or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, rheumatic pain and arthritis, and the aches and pains associated with colds and flu. reduces fever.

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

arrotex pharmaceuticals pty ltd - voriconazole, quantity: 200 mg - tablet, film coated - excipient ingredients: lactose monohydrate; pregelatinised maize starch; maize starch; croscarmellose sodium; povidone; silicon dioxide; magnesium stearate; titanium dioxide; hypromellose; triacetin - voriconazole is indicated for treatment of the following fungal infections:invasive aspergillosis. serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). serious fungal infections caused by scedosporium spp and fusarium spp. other serious fungal infections, in patients intolerant of, or refractory to, other therapy. prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

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

arrotex pharmaceuticals pty ltd - voriconazole, quantity: 50 mg - tablet, film coated - excipient ingredients: lactose monohydrate; pregelatinised maize starch; maize starch; croscarmellose sodium; povidone; silicon dioxide; magnesium stearate; titanium dioxide; hypromellose; triacetin - voriconazole is indicated for treatment of the following fungal infections:invasive aspergillosis. serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). serious fungal infections caused by scedosporium spp and fusarium spp. other serious fungal infections, in patients intolerant of, or refractory to, other therapy. prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

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

astrazeneca pty ltd - dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg) - tablet, film coated - excipient ingredients: silicon dioxide; microcrystalline cellulose; magnesium stearate; crospovidone; purified water; lactose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - type 2 diabetes mellitus,glycaemic control,forxiga is indicated in adults with type 2 diabetes mellitus:,? as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated.,? as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy (for example, high initial haemoglobin a1c [hba1c] levels).,? in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 pharmacodynamic properties ? clinical trials and section 4.4 special warnings and precautions for use for available data on different add-on combination therapies).,prevention of hospitalisation for heart failure,forxiga is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure (see section 5.1 pharmacodynamic properties ? clinical trials). heart failure,forxiga is indicated in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy (see section 5.1 pharmacodynamic properties). chronic kidney disease,forxiga is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (ckd stage 2,3 or 4 and urine acr ? 30 mg/g)

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

pierre fabre australia pty ltd - binimetinib, quantity: 15 mg - tablet, film coated - excipient ingredients: iron oxide black; macrogol 3350; colloidal anhydrous silica; purified talc; iron oxide yellow; microcrystalline cellulose; polyvinyl alcohol; magnesium stearate; titanium dioxide; croscarmellose sodium; lactose monohydrate - binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600e or v600k mutation, as detected by a validated test.

Malta - English - Medicines Authority

jubilant pharmaceuticals nv axxes business park, guldensporenpark 22 – block c, 9820 merelbeke, belgium - donepezil hydrochloride - film-coated tablet - donepezil hydrochloride 5 mg - psychoanaleptics

Malta - English - Medicines Authority

jubilant pharmaceuticals nv axxes business park, guldensporenpark 22 – block c, 9820 merelbeke, belgium - donepezil hydrochloride - film-coated tablet - donepezil hydrochloride 10 mg - psychoanaleptics