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

pfizer australia pty ltd - palbociclib, quantity: 75 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; silicon dioxide; crospovidone; magnesium stearate; succinic acid; titanium dioxide; hypromellose; triacetin; iron oxide red; indigo carmine aluminium lake - ibrance is indicated for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with: ? an aromatase inhibitor as initial endocrine-based therapy ? fulvestrant in patients who have received prior therapy.

European Union - English - EMA (European Medicines Agency)

ab science s.a. - masitinib mesilate - antineoplastic agents - dogs - treatment of non-resectable dog mast-cell tumours (grade 2 or 3) with confirmed mutated c-kit tyrosine-kinase receptor.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - erlotinib - carcinoma, non-small-cell lung; pancreatic neoplasms - antineoplastic agents - non-small cell lung cancer (nsclc)tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with egfr activating mutations and stable disease after first-line chemotherapy.tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.in patients with tumours without egfr activating mutations, tarceva is indicated when other treatment options are not considered suitable.when prescribing tarceva, factors associated with prolonged survival should be taken into account.no survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with epidermal growth factor receptor (egfr)-ihc - negative tumours.pancreatic cancertarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.when prescribing tarceva, factors associated with prolonged survival should be taken into account.

European Union - English - EMA (European Medicines Agency)

advanced accelerator applications - lutetium (177lu) oxodotreotide - neuroendocrine tumors - other therapeutic radiopharmaceuticals - lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (g1 and g2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (gep‑nets) in adults.

Israel - English - Ministry of Health

j-c health care ltd - selexipag - film coated tablets - selexipag 1000 mcg - selexipag - uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients with who functional class (fc) ii-iii, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (era) and/or a phosphodiesterase type 5 (pde-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.efficacy has been shown in a pah population including idiopathic and heritable pah, pah associated with connective tissue disorders, and pah associated with corrected simple congenital heart disease

Israel - English - Ministry of Health

j-c health care ltd - selexipag - film coated tablets - selexipag 1200 mcg - selexipag - uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients with who functional class (fc) ii-iii, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (era) and/or a phosphodiesterase type 5 (pde-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.efficacy has been shown in a pah population including idiopathic and heritable pah, pah associated with connective tissue disorders, and pah associated with corrected simple congenital heart disease

Israel - English - Ministry of Health

j-c health care ltd - selexipag - film coated tablets - selexipag 1400 mcg - selexipag - uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients with who functional class (fc) ii-iii, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (era) and/or a phosphodiesterase type 5 (pde-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.efficacy has been shown in a pah population including idiopathic and heritable pah, pah associated with connective tissue disorders, and pah associated with corrected simple congenital heart disease

Israel - English - Ministry of Health

j-c health care ltd - selexipag - film coated tablets - selexipag 1600 mcg - selexipag - uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients with who functional class (fc) ii-iii, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (era) and/or a phosphodiesterase type 5 (pde-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.efficacy has been shown in a pah population including idiopathic and heritable pah, pah associated with connective tissue disorders, and pah associated with corrected simple congenital heart disease

Israel - English - Ministry of Health

j-c health care ltd - selexipag - film coated tablets - selexipag 200 mcg - selexipag - uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients with who functional class (fc) ii-iii, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (era) and/or a phosphodiesterase type 5 (pde-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.efficacy has been shown in a pah population including idiopathic and heritable pah, pah associated with connective tissue disorders, and pah associated with corrected simple congenital heart disease

Israel - English - Ministry of Health

j-c health care ltd - selexipag - film coated tablets - selexipag 400 mcg - selexipag - uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (pah) in adult patients with who functional class (fc) ii-iii, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (era) and/or a phosphodiesterase type 5 (pde-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.efficacy has been shown in a pah population including idiopathic and heritable pah, pah associated with connective tissue disorders, and pah associated with corrected simple congenital heart disease