אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - perindopril erbumine, quantity: 4 mg; indapamide hemihydrate, quantity: 1.25 mg - tablet, uncoated - excipient ingredients: magnesium stearate; lactose - treatment of hypertension. treatment should not be initiated with this combination.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - perindopril arginine, quantity: 5 mg; indapamide hemihydrate, quantity: 1.25 mg - tablet, film coated - excipient ingredients: magnesium stearate; macrogol 6000; maltodextrin; sodium starch glycollate type a; colloidal anhydrous silica; lactose monohydrate; colour - treatment of hypertension. treatment should not be initiated with this combination.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - perindopril erbumine, quantity: 8 mg - tablet, uncoated - excipient ingredients: hydrophobic colloidal silica anhydrous; magnesium stearate; chlorophyllin-copper complex; lactose monohydrate; microcrystalline cellulose - treatment of hypertension. treatment of heart failure. in such patients it is recommended that perindo be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of perindo has not been demonstrated for new york heart association category iv patients). patients with established coronary artery disease (see clinical trials) who are stable on concomitant therapy and have no heart failure to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - perindopril erbumine, quantity: 4 mg - tablet, uncoated - excipient ingredients: magnesium stearate; microcrystalline cellulose; lactose monohydrate; hydrophobic colloidal silica anhydrous - treatment of hypertension. treatment of heart failure. in such patients it is recommended that perindo be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of perindo has not been demonstrated for new york heart association category iv patients). patients with established coronary artery disease (see clinical trials) who are stable on concomitant therapy and have no heart failure to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - perindopril erbumine, quantity: 2 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; magnesium stearate; hydrophobic colloidal silica anhydrous; lactose monohydrate - treatment of hypertension. treatment of heart failure. in such patients it is recommended that perindo be given with a diuretic and/or digoxin under close medical supervision. (the safety and efficacy of perindo has not been demonstrated for new york heart association category iv patients). patients with established coronary artery disease (see clinical trials) who are stable on concomitant therapy and have no heart failure to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - perindopril arginine, quantity: 5 mg; indapamide hemihydrate, quantity: 1.25 mg - tablet, film coated - excipient ingredients: sodium starch glycollate type a; lactose monohydrate; macrogol 6000; colloidal anhydrous silica; maltodextrin; magnesium stearate; colour - treatment of hypertension. treatment should not be initiated with this combination.

האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

novartis europharm limited - tislelizumab - esophageal squamous cell carcinoma - antineoplastic agents - oesophageal squamous cell carcinoma (oscc) tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; water for injections; citric acid monohydrate; mannitol; hydrochloric acid; adipic acid; polysorbate 80; sodium hydroxide - rheumatoid arthritis hyrimoz? is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.,hyrimoz? can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis hyrimoz? in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). hyrimoz? can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis hyrimoz? is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis hyrimoz? is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis hyrimoz? is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (?6 years) hyrimoz? is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab.,ulcerative colitis hyrimoz? is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see section 5.1 clinical trials).,psoriasis in adults and children hyrimoz? is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. hyrimoz? is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age) hyrimoz? is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis hyrimoz? is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; mannitol; sodium hydroxide; citric acid monohydrate; water for injections; hydrochloric acid; polysorbate 80; adipic acid - rheumatoid arthritis hyrimoz? is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.,hyrimoz? can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis hyrimoz? in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). hyrimoz? can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis hyrimoz? is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis hyrimoz? is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis hyrimoz? is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (?6 years) hyrimoz? is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab.,ulcerative colitis hyrimoz? is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see section 5.1 clinical trials).,psoriasis in adults and children hyrimoz? is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. hyrimoz? is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age) hyrimoz? is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis hyrimoz? is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - adalimumab, quantity: 80 mg - injection, solution - excipient ingredients: sodium chloride; sucrose; polysorbate 80; water for injections - rheumatoid arthritis,adalicip is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. adalicip can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,adalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing greater than or equal to 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). adalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,adalicip is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,adalicip is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,adalicip is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (greater than or equal to 6 years; weighing greater than or equal to 40 kg) adalicip is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis,adalicip is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties -clinical trials).,psoriasis in adults and children,adalicip is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,adalicip is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing greater than or equal to 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),adalicip is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,adalicip is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.