Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - acalabrutinib -

New Zealand - English - 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).

Singapore - English - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - acalabrutinib - capsule - acalabrutinib 100mg

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

astrazeneca pharmaceuticals lp - acalabrutinib (unii: i42748elqw) (acalabrutinib - unii:i42748elqw) - calquence is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy. this indication is approved under accelerated approval based on overall response rate [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. calquence is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll). none. risk summary based on findings in animals, calquence may cause fetal harm and dystocia when administered to a pregnant woman. there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of acalabrutinib to animals during organogenesis resulted in dystocia in rats and reduced fetal growth in rabbits at maternal exposures (auc) 2 times exposures in patients at the recommended dose of 100 mg approximately every 12 hours (s

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

astrazeneca pharmaceuticals lp - acalabrutinib (unii: i42748elqw) (acalabrutinib - unii:i42748elqw) - acalabrutinib 100 mg - calquence is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy. this indication is approved under accelerated approval based on overall response rate [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. calquence is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll). none. risk summary based on findings in animals, calquence may cause fetal harm and dystocia when administered to a pregnant woman. there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of acalabrutinib to animals during organogenesis resulted in dystocia in rats and reduced fetal growth in rabbits at maternal exposures (auc) 2 times exposures in patients at the recommended dose of 100 mg approximately every 12 hours (s

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

astrazeneca pharmaceuticals (pty) ltd - capsules - see ingredients - each capsule contains acalabrutinib 100,0 mg

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

genentech, inc. - glofitamab (unii: 06p3klk2j8) (glofitamab - unii:06p3klk2j8) - columvi is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma, not otherwise specified (dlbcl, nos) or large b-cell lymphoma (lbcl) arising from follicular lymphoma, after two or more lines of systemic therapy. this indication is approved under accelerated approval based on response rate and durability of response [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none. risk summary based on its mechanism of action columvi may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of columvi in pregnant women to evaluate for a drug-associated risk. no animal reproductive and developmental toxicity studies have been conducted with glofitamab-gxbm. glofitamab-gxbm causes t-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. i

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

astrazeneca pty ltd - acalabrutinib, quantity: 100 mg - capsule, hard - excipient ingredients: iron oxide yellow; indigo carmine aluminium lake; pregelatinised starch; sodium starch glycollate type a; gelatin; shellac; silicified microcrystalline cellulose; propylene glycol; titanium dioxide; iron oxide black; magnesium stearate - 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 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).

Australia - English - 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).

Singapore - English - HSA (Health Sciences Authority)

abbvie pte. ltd. - venetoclax - tablet, film coated - venetoclax 100.0 mg