Canada - English - Health Canada

abbvie corporation - venetoclax; venetoclax; venetoclax - kit - 10mg; 50mg; 100mg - venetoclax 10mg; venetoclax 50mg; venetoclax 100mg - antineoplastic agents

United States - English - NLM (National Library of Medicine)

abbvie inc. - venetoclax (unii: n54aic43pw) (venetoclax - unii:n54aic43pw) - venetoclax 10 mg - venclexta is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll). venclexta is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (aml) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. concomitant use of venclexta with strong cyp3a inhibitors at initiation and during the ramp-up phase is contraindicated in patients with cll/sll due to the potential for increased risk of tumor lysis syndrome [see dosage and administration ( 2.6 ) and drug interactions ( 7.1 )] . risk summary based on findings in animals and its mechanism of action [see clinical pharmacology ( 12.1 )] , venclexta may cause embryo-fetal harm when administered to a pregnant woman. there are no available data on venclexta use in pregnant women to inform a drug-associated risk. administration of venetoclax to pregnant mice during

New Zealand - English - Medsafe (Medicines Safety Authority)

abbvie limited - venetoclax 10mg;  ; venetoclax 50mg; venetoclax 100mg - film coated tablet - active: venetoclax 10mg   excipient: calcium hydrogen phosphate colloidal silicon dioxide copovidone opadry ii yellow 85f32450 polysorbate 80 purified water sodium stearyl fumarate active: venetoclax 50mg excipient: calcium hydrogen phosphate colloidal silicon dioxide copovidone opadry ii beige 85f97497 polysorbate 80 purified water sodium stearyl fumarate active: venetoclax 100mg excipient: calcium hydrogen phosphate colloidal silicon dioxide copovidone opadry ii yellow 85f32450 polysorbate 80 purified water sodium stearyl fumarate - venclexta is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll).

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - venetoclax - film coated tablets - venetoclax 10 mg - venetoclax - chronic lymphocytic leukemia/small lymphocytic lymphomavenclexta in combination with rituximab or as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll), who have received at least one prior therapy.venclexta in combination with obinutuzumab is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll).acute myeloid leukemiavenclexta in combination with a hypomethylating agent or in combination with low dose cytarabine is indicated for newly diagnosed patients with acute myeloid leukemia (aml) who are ineligible for intensive chemotherapy.

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - venetoclax - film coated tablets - venetoclax 10 mg - venetoclax - chronic lymphocytic leukemia/small lymphocytic lymphoma :venclexta in combination with rituximab or as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll), who have received at least one prior therapy.venclexta in combination with obinutuzumab is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll).acute myeloid leukemia :venclexta in combination with a hypomethylating agent or in combination with low dose cytarabine is indicated for newly diagnosed patients with acute myeloid leukemia (aml) who are ineligible for intensive chemotherapy.

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - venetoclax - film coated tablets - venetoclax 10 mg - venetoclax - chronic lymphocytic leukemia/small lymphocytic lymphoma :venclexta in combination with rituximab or as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll), who have received at least one prior therapy.venclexta in combination with obinutuzumab is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll).acute myeloid leukemia :venclexta in combination with a hypomethylating agent or in combination with low dose cytarabine is indicated for newly diagnosed patients with acute myeloid leukemia (aml) who are ineligible for intensive chemotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

abbvie limited - venetoclax 10mg;   - film coated tablet - 10 mg - active: venetoclax 10mg   excipient: calcium hydrogen phosphate colloidal silicon dioxide copovidone opadry ii yellow 85f32450 polysorbate 80 purified water sodium stearyl fumarate - venclexta is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll).

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.

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - venetoclax - film coated tablets - venetoclax 10 mg - venetoclax - chronic lymphocytic leukemia/small lymphocytic lymphomavenclexta in combination with rituximab or as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll), who have received at least one prior therapy.venclexta in combination with obinutuzumab is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (cll) or small lymphocytic lymphoma (sll).acute myeloid leukemiavenclexta in combination with a hypomethylating agent or in combination with low dose cytarabine is indicated for newly diagnosed patients with acute myeloid leukemia (aml) who are ineligible for intensive chemotherapy.