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

pfizer australia pty ltd - lorlatinib, quantity: 25 mg - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; sodium starch glycollate; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; macrogol 3350; iron oxide black - lorviqua is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc), as determined by a validated test.

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

pfizer australia pty ltd - lorlatinib, quantity: 100 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; magnesium stearate; microcrystalline cellulose; calcium hydrogen phosphate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; macrogol 3350; iron oxide black - lorviqua is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc), as determined by a validated test.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - lorlatinib - film coated tablets - lorlatinib 25 mg - lorlatinib - lorviqua is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk) positive.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - lorlatinib - film coated tablets - lorlatinib 100 mg - lorlatinib - lorviqua is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk) positive.

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

pfizer australia pty ltd - lorlatinib, quantity: 25 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; calcium hydrogen phosphate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; macrogol 3350; iron oxide black - lorviqua is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc), as determined by a validated test.

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

pfizer australia pty ltd - lorlatinib, quantity: 100 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; calcium hydrogen phosphate; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; macrogol 3350; iron oxide black - lorviqua is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc), as determined by a validated test.

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

pfizer laboratories div pfizer inc - lorlatinib (unii: osp71s83eu) (lorlatinib - unii:osp71s83eu) - lorbrena® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk)-positive as detected by an fda-approved test. lorbrena is contraindicated in patients taking strong cyp3a inducers, due to the potential for serious hepatotoxicity [see warnings and precautions (5.1)] . risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , lorbrena can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on lorbrena use in pregnant women. administration of lorlatinib to pregnant rats and rabbits by oral gavage during the period of organogenesis resulted in malformations, increased post-implantation loss, and abortion at maternal exposures that were equal to or less than the human exposure at the recommended dose of 100 mg once daily based on auc (see data) . advise a pregnant woman of the potential risk to a fetus. in the u.s. general p

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

u.s. pharmaceuticals - lorlatinib (unii: osp71s83eu) (lorlatinib - unii:osp71s83eu) - lorbrena® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk)-positive as detected by an fda-approved test. lorbrena is contraindicated in patients taking strong cyp3a inducers, due to the potential for serious hepatotoxicity [see warnings and precautions (5.1)] . risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , lorbrena can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on lorbrena use in pregnant women. administration of lorlatinib to pregnant rats and rabbits by oral gavage during the period of organogenesis resulted in malformations, increased post-implantation loss, and abortion at maternal exposures that were equal to or less than the human exposure at the recommended dose of 100 mg once daily based on auc (see data) . advise a pregnant woman of the potential risk to a fetus. in the u.s. general p

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - lorlatinib - carcinoma, non-small-cell lung - antineoplastic agents, protein kinase inhibitors - lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor.lorviqua as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc whose disease has progressed after:alectinib or ceritinib as the first alk tyrosine kinase inhibitor (tki) therapy; orcrizotinib and at least one other alk tki.

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - lorlatinib - tablet, film coated - lorlatinib 100 mg