Ирландия - английски - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - milbemycin oxime; praziquantel - tablet - 2.5, 25.0 mg/tablet - milbemycin oxime, combinations - dogs - endoparasiticide

Австралия - английски - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - vildagliptin, quantity: 50 mg; metformin hydrochloride, quantity: 1000 mg - tablet, film coated - excipient ingredients: iron oxide yellow; titanium dioxide; hypromellose; macrogol 4000; hyprolose; purified talc; magnesium stearate - for patients with type 2 diabetes mellitus (t2dm):,galvumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients whose diabetes is not adequately controlled on metformin hydrochloride alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. treatment should not be initiated with this fixed-dose combination.,galvumet is indicated in combination with a sulfonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulfonylurea.,galvumet is indicated as add-on to insulin as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - metformin hydrochloride, quantity: 850 mg; vildagliptin, quantity: 50 mg - tablet, film coated - excipient ingredients: macrogol 4000; hypromellose; iron oxide yellow; magnesium stearate; titanium dioxide; hyprolose; purified talc - for patients with type 2 diabetes mellitus (t2dm):,galvumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients whose diabetes is not adequately controlled on metformin hydrochloride alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. treatment should not be initiated with this fixed-dose combination.,galvumet is indicated in combination with a sulfonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulfonylurea.,galvumet is indicated as add-on to insulin as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - metformin hydrochloride, quantity: 500 mg; vildagliptin, quantity: 50 mg - tablet, film coated - excipient ingredients: hypromellose; macrogol 4000; titanium dioxide; magnesium stearate; purified talc; iron oxide yellow; iron oxide red; hyprolose - for patients with type 2 diabetes mellitus (t2dm):,galvumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients whose diabetes is not adequately controlled on metformin hydrochloride alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. treatment should not be initiated with this fixed-dose combination.,galvumet is indicated in combination with a sulfonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulfonylurea.,galvumet is indicated as add-on to insulin as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - risperidone, quantity: 4 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol; iron oxide red - ? risperidone tablets are indicated for the treatment of schizophrenia and related psychoses. ? risperidone tablets are indicated for the short-term treatment of acute mania associated with bipolar 1 disorder (see section 4.2 dose and method of administration ? bipolar mania)). ? risperidone tablets are also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type. (see section 4.2 dose and method of administration: behavioural disturbances in dementia) ? risperidone tablets are indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (eg. aggression, impulsivity and self-injurious behaviours) are prominent. (see section 5.1 pharmacodynamic properties ? clinical trials for maintenance data). ? risperidone tablets are indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see section 5.1 pharmacodynamic properties ? clinical trials)

Австралия - английски - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - risperidone, quantity: 3 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol; iron oxide yellow - ? risperidone tablets are indicated for the treatment of schizophrenia and related psychoses. ? risperidone tablets are indicated for the short-term treatment of acute mania associated with bipolar 1 disorder (see section 4.2 dose and method of administration ? bipolar mania)). ? risperidone tablets are also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type. (see section 4.2 dose and method of administration: behavioural disturbances in dementia) ? risperidone tablets are indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (eg. aggression, impulsivity and self-injurious behaviours) are prominent. (see section 5.1 pharmacodynamic properties ? clinical trials for maintenance data). ? risperidone tablets are indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see section 5.1 pharmacodynamic properties ? clinical trials)

Австралия - английски - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - risperidone, quantity: 2 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol; sunset yellow fcf aluminium lake - ? risperidone tablets are indicated for the treatment of schizophrenia and related psychoses. ? risperidone tablets are indicated for the short-term treatment of acute mania associated with bipolar 1 disorder (see section 4.2 dose and method of administration ? bipolar mania)). ? risperidone tablets are also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type. (see section 4.2 dose and method of administration: behavioural disturbances in dementia) ? risperidone tablets are indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (eg. aggression, impulsivity and self-injurious behaviours) are prominent. (see section 5.1 pharmacodynamic properties ? clinical trials for maintenance data). ? risperidone tablets are indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see section 5.1 pharmacodynamic properties ? clinical trials)

Австралия - английски - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - risperidone, quantity: 1 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol - ? risperidone tablets are indicated for the treatment of schizophrenia and related psychoses. ? risperidone tablets are indicated for the short-term treatment of acute mania associated with bipolar 1 disorder (see section 4.2 dose and method of administration ? bipolar mania)). ? risperidone tablets are also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type. (see section 4.2 dose and method of administration: behavioural disturbances in dementia) ? risperidone tablets are indicated in the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (eg. aggression, impulsivity and self-injurious behaviours) are prominent. (see section 5.1 pharmacodynamic properties ? clinical trials for maintenance data). ? risperidone tablets are indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see section 5.1 pharmacodynamic properties ? clinical trials)

Австралия - английски - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - aciclovir, quantity: 200 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica - aciclovir tablets are indicated for use in adult patients for: (1) the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. (2) the treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. (3) the management of patients with advanced symptomatic hiv disease (cd4 + counts < 150 x 10(6)/l). in accordance with details specified in the "indications" and the "dosage and adminsitration" sections of the approved product information provided as attachment 1.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - aciclovir, quantity: 800 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica - aciclovir tablets are indicated for use in adult patients for: (1) the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. (2) the treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. (3) the management of patients with advaned symptomatic hiv disease cd4 + counts < 150 x 10(6)/l). in accordance with details specified in the "indications" and the "dosage and administration" sections of the approved product information provided as attachment 1.