European Union - English - EMA (European Medicines Agency)

seqirus s.r.l.  - zoonotic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza a virus, h5n1 subtype - vaccines - active immunisation against h5 subtype of influenza a virus

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

cipla australia pty ltd - entecavir monohydrate, quantity: 0.532 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; hyprolose; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; macrogol 6000 - entac is indicated for the treatment of chronic hepatitis b virus infection in adults 16 years or older with evidence of active liver inflammation.,this indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

cipla australia pty ltd - entecavir monohydrate, quantity: 0.532 mg - tablet, film coated - excipient ingredients: crospovidone; lactose monohydrate; microcrystalline cellulose; hyprolose; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000 - entecavir-gh is indicated for the treatment of chronic hepatitis b virus infection in adults 16 years or older with evidence of active liver inflammation.,this indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

cipla australia pty ltd - entecavir monohydrate, quantity: 1.064 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; hyprolose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - entac is indicated for the treatment of chronic hepatitis b virus infection in adults 16 years or older with evidence of active liver inflammation.,this indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

cipla australia pty ltd - entecavir monohydrate, quantity: 1.064 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; hyprolose; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - entecavir-gh is indicated for the treatment of chronic hepatitis b virus infection in adults 16 years or older with evidence of active liver inflammation.,this indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

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

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg); metformin hydrochloride, quantity: 1000 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; sodium stearylfumarate; povidone; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - velmetia (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 850 mg; sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium stearylfumarate; povidone; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - velmetia (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

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

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg); metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: povidone; microcrystalline cellulose; sodium stearylfumarate; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - velmetia (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

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

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 32.13 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; sodium stearylfumarate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - xelevia (sitagliptin phosphate monohydrate) 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)

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; calcium hydrogen phosphate; croscarmellose sodium; sodium stearylfumarate; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - xelevia (sitagliptin phosphate monohydrate) 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.