Israel - English - 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).

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

Singapore - English - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - acalabrutinib maleate eqv acalabrutinib - tablet, film coated - acalabrutinib maleate eqv acalabrutinib 100mg

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).

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

uriel pharmacy inc. - astragalus propinquus root (unii: 922op8yupf) (astragalus propinquus root - unii:922op8yupf) - astragalus propinquus root 3 [hp_x] in 1 ml - directions: for oral use. use: temporary relief of headache.

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

uriel pharmacy inc. - astragalus propinquus root (unii: 922op8yupf) (astragalus propinquus root - unii:922op8yupf) - astragalus propinquus root 2 [hp_x] in 1 ml - directions: for oral use only. use: temporary relief of headache.

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

uriel pharmacy inc. - astragalus propinquus root (unii: 922op8yupf) (astragalus propinquus root - unii:922op8yupf), arnica montana (unii: o80ty208zw) (arnica montana - unii:o80ty208zw) - astragalus propinquus root 3 [hp_x] in 1 ml - directions: for oral use only. use: temporary relief of headache.

European Union - English - 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.

Canada - English - Health Canada

astrazeneca canada inc - acalabrutinib - capsule - 100mg - acalabrutinib 100mg - antineoplastic agents