Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

astrazeneca ab - acalabrutinib - leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors, - calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll).calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

astrazeneca limited - acalabrutinib 100mg - capsule - 100 mg - active: acalabrutinib 100mg excipient: black ink (calquence) gelatin indigo carmine iron oxide yellow magnesium stearate silicified microcrystalline cellulose sodium starch glycolate starch titanium dioxide - calquence is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. calquence is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll)/small lymphocytic lymphoma (sll).

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lipegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: acetic acid; polysorbate 20; sorbitol; sodium hydroxide; water for injections - lonquex? is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)

Israel - Tiếng Anh - Ministry of Health

astrazeneca (israel) ltd - acalabrutinib - capsules - acalabrutinib 100 mg - mantle cell lymphomacalquence is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.chronic lymphocytic leukemia or small lymphocytic lymphomacalquence is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll)or small lymphocytic lymphoma (sll).

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - acalabrutinib maleate monohydrate, quantity: 129 mg - tablet, film coated - excipient ingredients: mannitol; microcrystalline cellulose; hyprolose; sodium stearylfumarate; hypromellose; copovidone; titanium dioxide; macrogol 3350; medium chain triglycerides; iron oxide yellow; iron oxide red - calquence is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.,this indication is approved via the provisional approval pathway, based on overall response rate. full registration for this indication depends on verification and description of clinical benefit in confirmatory trials. calquence is indicated for the treatment of patients with chronic lymphocytic leukaemia (cll)/small lymphocytic lymphoma (sll).

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - quetiapine fumarate, quantity: 230.244 mg (equivalent: quetiapine, qty 200 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate type a; calcium hydrogen phosphate dihydrate; purified talc; povidone; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - bipolar disorder,adults,? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes,? treatment of depressive episodes associated with bipolar disorder (see dosage and administration),? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years,? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years),? treatment of schizophrenia

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - quetiapine fumarate, quantity: 115.122 mg (equivalent: quetiapine, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate dihydrate; purified talc; colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; povidone; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - bipolar disorder,adults,? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes,? treatment of depressive episodes associated with bipolar disorder (see dosage and administration),? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years,? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years),? treatment of schizophrenia

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - quetiapine fumarate, quantity: 172.683 mg (equivalent: quetiapine, qty 150 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; calcium hydrogen phosphate dihydrate; povidone; magnesium stearate; microcrystalline cellulose; purified talc; colloidal anhydrous silica; sodium starch glycollate type a; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - bipolar disorder,adults,? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes,? treatment of depressive episodes associated with bipolar disorder (see dosage and administration),? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years,? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years),? treatment of schizophrenia

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - quetiapine fumarate, quantity: 115.122 mg (equivalent: quetiapine, qty 100 mg) - tablet, film coated - excipient ingredients: magnesium stearate; calcium hydrogen phosphate dihydrate; colloidal anhydrous silica; lactose monohydrate; sodium starch glycollate type a; purified talc; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - bipolar disorder,adults,? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes,? treatment of depressive episodes associated with bipolar disorder (see dosage and administration),? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years,? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years),? treatment of schizophrenia

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - quetiapine fumarate, quantity: 345.366 mg (equivalent: quetiapine, qty 300 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; macrogol 400; calcium hydrogen phosphate dihydrate; povidone; hypromellose; colloidal anhydrous silica; titanium dioxide; magnesium stearate; purified talc; sodium starch glycollate type a; lactose monohydrate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - bipolar disorder,adults,? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes,? treatment of depressive episodes associated with bipolar disorder (see dosage and administration),? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years,? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years),? treatment of schizophrenia