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

abbvie pty ltd - beractant -

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

abbvie pty ltd - isoflurane -

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

abbvie pty ltd - venetoclax, quantity: 100 mg - tablet, film coated - excipient ingredients: sodium stearylfumarate; colloidal anhydrous silica; copovidone; calcium hydrogen phosphate; polysorbate 80; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - acute myeloid leukaemia,venclexta, as part of combination therapy, is indicated for the treatment of newly diagnosed adult patients with acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.,this medicine has provisional approval in australia for the treatment of newly diagnosed patients with aml who are ineligible for intensive chemotherapy. the decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). continued approval of this indication depends on verification and description of benefit in confirmatory trials. chronic lymphocytic leukaemia/small lymphocytic lymphoma,venclexta in combination with obinutuzumab is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll) who are considered unfit or unsuitable for chemo-immunotherapy.,venclexta in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.,venclexta monotherapy is indicated for the treatment of:,? patients with relapsed or refractory cll with 17p deletion, or,? patients with relapsed or refractory cll for whom there are no other suitable treatment options.,acute myeloid leukaemia,venclexta, in combination with azacitidine or low-dose cytarabine, is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

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

abbvie pty ltd - venetoclax, quantity: 50 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; sodium stearylfumarate; copovidone; colloidal anhydrous silica; polysorbate 80; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - chronic lymphocytic leukaemia/small lymphocytic lymphoma,venclexta in combination with obinutuzumab is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll) who are considered unfit or unsuitable for chemo-immunotherapy.,venclexta in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.,venclexta monotherapy is indicated for the treatment of:,? patients with relapsed or refractory cll with 17p deletion, or,? patients with relapsed or refractory cll for whom there are no other suitable treatment options.,acute myeloid leukaemia,venclexta, in combination with azacitidine or low-dose cytarabine, is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy. acute myeloid leukaemia,venclexta, as part of combination therapy, is indicated for the treatment of newly diagnosed adult patients with acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.,this medicine has provisional approval in australia for the treatment of newly diagnosed patients with aml who are ineligible for intensive chemotherapy. the decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). continued approval of this indication depends on verification and description of benefit in confirmatory trials.

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

abbvie pty ltd - venetoclax, quantity: 50 mg - tablet, film coated - excipient ingredients: sodium stearylfumarate; copovidone; polysorbate 80; colloidal anhydrous silica; calcium hydrogen phosphate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - acute myeloid leukaemia,venclexta, as part of combination therapy, is indicated for the treatment of newly diagnosed adult patients with acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.,this medicine has provisional approval in australia for the treatment of newly diagnosed patients with aml who are ineligible for intensive chemotherapy. the decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). continued approval of this indication depends on verification and description of benefit in confirmatory trials. chronic lymphocytic leukaemia/small lymphocytic lymphoma,venclexta in combination with obinutuzumab is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll) who are considered unfit or unsuitable for chemo-immunotherapy.,venclexta in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.,venclexta monotherapy is indicated for the treatment of:,? patients with relapsed or refractory cll with 17p deletion, or,? patients with relapsed or refractory cll for whom there are no other suitable treatment options.,acute myeloid leukaemia,venclexta, in combination with azacitidine or low-dose cytarabine, is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

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

abbvie pty ltd - venetoclax, quantity: 10 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; copovidone; sodium stearylfumarate; polysorbate 80; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - chronic lymphocytic leukaemia/small lymphocytic lymphoma,venclexta in combination with obinutuzumab is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll) who are considered unfit or unsuitable for chemo-immunotherapy.,venclexta in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.,venclexta monotherapy is indicated for the treatment of:,? patients with relapsed or refractory cll with 17p deletion, or,? patients with relapsed or refractory cll for whom there are no other suitable treatment options.,acute myeloid leukaemia,venclexta, in combination with azacitidine or low-dose cytarabine, is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy. chronic lymphocytic leukaemia/small lymphocytic lymphoma,venclexta in combination with obinutuzumab is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll) who are considered unfit or unsuitable for chemo-immunotherapy.,venclexta in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.,venclexta monotherapy is indicated for the treatment of: ? patients with relapsed or refractory cll with 17p deletion, or ? patients with relapsed or refractory cll for whom there are no other suitable treatment options.

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

abbvie pty ltd - leuprorelin acetate, quantity: 45 mg - injection - excipient ingredients: mannitol; polylactic acid; stearic acid; glacial acetic acid; carmellose sodium; polysorbate 80; water for injections - lucrin depot is indicated for the palliative treatment of metastatic or locally advanced prostate cancer.

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

abbvie pty ltd - leuprorelin acetate, quantity: 30 mg - injection, modified release - excipient ingredients: mannitol; polylactic acid - lucrin depot paediatric 30 mg 3-month pds injection is indicated in the treatment of children with central precocious puberty (cpp).

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

abbvie pty ltd - adalimumab, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium chloride; monobasic sodium phosphate dihydrate; citric acid monohydrate; dibasic sodium phosphate dihydrate; polysorbate 80; water for injections; sodium citrate dihydrate; mannitol - rheumatoid arthritis: humira 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. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis: - polyarticular juvenile idiopathic arthritis: humira 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). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - enthesitis-related arthritis: humira 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: humira 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: humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn's disease in adults and children (6 years and older): humira 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 of infliximab.,ulcerative colitis: humira 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 clinical trials).,psoriasis in adults and children: humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira 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): humira 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: humira 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.

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

abbvie pty ltd - adalimumab, quantity: 50 mg/ml - injection, solution - excipient ingredients: dibasic sodium phosphate dihydrate; polysorbate 80; monobasic sodium phosphate dihydrate; sodium chloride; citric acid monohydrate; water for injections; sodium citrate dihydrate; mannitol - rheumatoid arthritis: humira 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. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis: - polyarticular juvenile idiopathic arthritis: humira 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). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - enthesitis-related arthritis: humira 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: humira 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: humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn's disease in adults and children (6 years and older): humira 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 of infliximab.,ulcerative colitis: humira 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 clinical trials).,psoriasis in adults and children: humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira 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): humira 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: humira 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.