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).

Canada - English - Health Canada

hollister-stier, unit pharm, division of miles canada inc. - bacterials - suspension - nil - bacterials nil - allergenic extracts

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - ibrutinib 140mg;  ;   - capsule - 140 mg - active: ibrutinib 140mg     excipient: croscarmellose sodium gelatin magnesium stearate microcrystalline cellulose opacode black s-1-17822 opacode black s-1-17823 sodium laurilsulfate titanium dioxide - imbruvica is indicated for the treatment of · patients with mcl who have received at least one prior therapy

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

target corporation - benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y) - antibacterial for handwashing to decrease bacteria on the skin - if irritation and redness develop - comdition persists for more than 72 hours

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

key diagnostics pty ltd - ct353 - bacterial infectious disease ivds - bacterial infectious diseases ivds.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - film coated tablets - ibrutinib 140 mg - ibrutinib - • mantle cell lymphoma:imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.• chronic lymphocytic leukemia/small lymphocytic lymphoma :imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)• chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion:imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion.• waldenström’s macroglobulinemiaimbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm).• marginal zone lymphomaimbruvica is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who require systemic therapy and have received at least one prior anti-cd20-based therapy.• chronic graft versus host diseaseimbruvica is indicated for the treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - film coated tablets - ibrutinib 280 mg - ibrutinib - • mantle cell lymphoma:imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.• chronic lymphocytic leukemia/small lymphocytic lymphoma :imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)• chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion:imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion.• waldenström’s macroglobulinemiaimbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm).• marginal zone lymphomaimbruvica is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who require systemic therapy and have received at least one prior anti-cd20-based therapy.• chronic graft versus host diseaseimbruvica is indicated for the treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - film coated tablets - ibrutinib 420 mg - ibrutinib - • mantle cell lymphoma:imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.• chronic lymphocytic leukemia/small lymphocytic lymphoma :imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)• chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion:imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion.• waldenström’s macroglobulinemiaimbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm).• marginal zone lymphomaimbruvica is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who require systemic therapy and have received at least one prior anti-cd20-based therapy.• chronic graft versus host diseaseimbruvica is indicated for the treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - film coated tablets - ibrutinib 560 mg - ibrutinib - • mantle cell lymphoma:imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.• chronic lymphocytic leukemia/small lymphocytic lymphoma :imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)• chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion:imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion.• waldenström’s macroglobulinemiaimbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm).• marginal zone lymphomaimbruvica is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who require systemic therapy and have received at least one prior anti-cd20-based therapy.• chronic graft versus host diseaseimbruvica is indicated for the treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy.

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).