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

pfizer laboratories div pfizer inc - crizotinib (unii: 53ah36668s) (crizotinib - unii:53ah36668s) - crizotinib 250 mg - xalkori is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk) or ros1-positive as detected by an fda-approved test [see dosage and administration (2.1)] . xalkori is indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (alcl) that is alk-positive. limitations of use : the safety and efficacy of xalkori have not been established in older adults with relapsed or refractory, systemic alk-positive alcl. xalkori is indicated for the treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (imt) that is alk-positive. none. risk summary based on findings from animal studies and its mechanism of action, xalkori can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available dat

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - crizotinib - capsules - crizotinib 200 mg - crizotinib - crizotinib - xalkori is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive. xalkori is indicated for the treatment of patients with metastatic nsclc whose tumors are ros1-positive.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - crizotinib - capsules - crizotinib 200 mg - crizotinib - crizotinib - xalkori is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive. xalkori is indicated for the treatment of patients with metastatic nsclc whose tumors are ros1-positive.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - crizotinib - capsules - crizotinib 250 mg - crizotinib - crizotinib - xalkori is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive. xalkori is indicated for the treatment of patients with metastatic nsclc whose tumors are ros1-positive.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - crizotinib - capsules - crizotinib 250 mg - crizotinib - crizotinib - xalkori is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive. xalkori is indicated for the treatment of patients with metastatic nsclc whose tumors are ros1-positive.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - crizotinib - carcinoma, non-small-cell lung - antineoplastic agents - xalkori as monotherapy is indicated for:the first‑line treatment of adults with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc)the treatment of adults with previously treated anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc)the treatment of adults with ros1‑positive advanced non‑small cell lung cancer (nsclc)the treatment of paediatric patients (age ≥6 to

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - crizotinib 200mg;  ;   - capsule - 200 mg - active: crizotinib 200mg     excipient: calcium hydrogen phosphate colloidal silicon dioxide gelatin iron oxide red magnesium stearate microcrystalline cellulose sodium starch glycolate tekprint black sw-9008 titanium dioxide - xalkori is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive advanced non-small cell lung cancer (nsclc). xalkori is indicated for the treatment of patients with ros1-positive advanced non-small cell lung cancer (nsclc).

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - crizotinib 250mg;  ;   - capsule - 250 mg - active: crizotinib 250mg     excipient: calcium hydrogen phosphate colloidal silicon dioxide gelatin iron oxide red magnesium stearate microcrystalline cellulose sodium starch glycolate tekprint black sw-9008 titanium dioxide - xalkori is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive advanced non-small cell lung cancer (nsclc). xalkori is indicated for the treatment of patients with ros1-positive advanced non-small cell lung cancer (nsclc).

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

pfizer australia pty ltd - crizotinib, quantity: 250 mg - capsule, hard - excipient ingredients: gelatin; calcium hydrogen phosphate; iron oxide red; sodium starch glycollate; microcrystalline cellulose; titanium dioxide; colloidal anhydrous silica; magnesium stearate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - xalkori is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive advanced non-small cell lung cancer (nsclc). xalkori is indicated for the treatment of patients with ros1-positive advanced non-small cell lung cancer (nsclc).

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

pfizer australia pty ltd - crizotinib, quantity: 200 mg - capsule, hard - excipient ingredients: titanium dioxide; gelatin; calcium hydrogen phosphate; colloidal anhydrous silica; microcrystalline cellulose; iron oxide red; magnesium stearate; sodium starch glycollate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - xalkori is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive advanced non-small cell lung cancer (nsclc). xalkori is indicated for the treatment of patients with ros1-positive advanced non-small cell lung cancer (nsclc).