Israel - English - Ministry of Health

eli lilly israel ltd, israel - abemaciclib - film coated tablets - abemaciclib 150 mg - abemaciclib - verzenio™ (abemaciclib) is indicated:•in combination with a non-steroidal aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer.•in combination with fulvestrant for the treatment of women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.•as monotherapy for the treatment of adult patients with hr-positive, her2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy in the metastatic setting and prior chemotherapy in the metastatic setting including taxane in adjuvant or metastatic setting.verzenio should not be used in women after prior treatment with cyclin-dependent kinases 4 and 6 (cdk4 and cdk6) inhibitor..• verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence.in pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.

Israel - English - Ministry of Health

eli lilly israel ltd, israel - abemaciclib - film coated tablets - abemaciclib 200 mg - abemaciclib - verzenio™ (abemaciclib) is indicated:•in combination with a non-steroidal aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer.•in combination with fulvestrant for the treatment of women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.•as monotherapy for the treatment of adult patients with hr-positive, her2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy in the metastatic setting and prior chemotherapy in the metastatic setting including taxane in adjuvant or metastatic setting.verzenio should not be used in women after prior treatment with cyclin-dependent kinases 4 and 6 (cdk4 and cdk6) inhibitor.• verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence.in pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.

Israel - English - Ministry of Health

eli lilly israel ltd, israel - abemaciclib - film coated tablets - abemaciclib 50 mg - abemaciclib - verzenio™ (abemaciclib) is indicated:•in combination with a non-steroidal aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer.•in combination with fulvestrant for the treatment of women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.•as monotherapy for the treatment of adult patients with hr-positive, her2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy in the metastatic setting and prior chemotherapy in the metastatic setting including taxane in adjuvant or metastatic setting.verzenio should not be used in women after prior treatment with cyclin-dependent kinases 4 and 6 (cdk4 and cdk6) inhibitor.• verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence.in pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.

Israel - English - Ministry of Health

novartis israel ltd - trametinib as dimethyl sulfoxide - film coated tablets - trametinib as dimethyl sulfoxide 0.5 mg - trametinib - trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy. non-small cell lung cancer (nsclc) :trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.adjuvant treatment of melanoma :trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection.braf v600e mutation-positive locally advanced or metastatic anaplastic thyroid cancertafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment optionsbraf v600e mutation-positive unresectable or metastatic solid tumorsmekinist is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. limitations of use: trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to braf inhibitiontrametinib is indicated, in combination with dabrafenib, for the treatment of pediatric patients 6 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy

Israel - English - Ministry of Health

novartis israel ltd - trametinib as dimethyl sulfoxide - film coated tablets - trametinib as dimethyl sulfoxide 2 mg - trametinib - trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy. non-small cell lung cancer (nsclc) :trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.adjuvant treatment of melanoma :trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection.braf v600e mutation-positive locally advanced or metastatic anaplastic thyroid cancertafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment optionsbraf v600e mutation-positive unresectable or metastatic solid tumorsmekinist is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with braf v600e mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. limitations of use: trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to braf inhibitiontrametinib is indicated, in combination with dabrafenib, for the treatment of pediatric patients 6 year of age and older with low-grade glioma (lgg) with a braf v600e mutation who require systemic therapy

Israel - English - Ministry of Health

eli lilly israel ltd, israel - ramucirumab - concentrate for solution for infusion - ramucirumab 10 mg/ml - ramucirumab - gastric cancercyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy. cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate.colorectal cancercyramza, in combination with folfiri (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mcrc) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.non-small cell lung cancercyramza in combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung adenocarcinoma with activating epidermal growth factor receptor (egfr) mutations.cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.hepatocellular carcinomacyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (afp) of ≥ 400 ng/ml and who have been previously treated with sorafenib.

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

bristol-myers squibb australia pty ltd - nivolumab, quantity: 250 mg - injection, solution - excipient ingredients: sodium citrate dihydrate; sodium chloride; mannitol; pentetic acid; polysorbate 80; hydrochloric acid; sodium hydroxide; water for injections - melanoma,opdivo, as monotherapy, is indicated for the adjuvant treatment of adults and adolescent patients 12 years and older with completely resected stage iib, iic, iii or iv melanoma.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,opdivo, in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. the approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. all analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,non-small cell lung cancer (nsclc),opdivo, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (nsclc).,opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (nsclc) with no egfr or alk genomic tumour aberrations.,opdivo, as monotherapy, is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (nsclc) with progression on or after prior chemotherapy.,opdivo, as monotherapy, is indicated for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsclc) with progression on or after prior chemotherapy. in patients with tumour egfr or alk genomic aberrations, opdivo should be used after progression on or after targeted therapy.,malignant pleural mesothelioma (mpm),opdivo, in combination with ipilimumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,renal cell carcinoma (rcc),opdivo, in combination with ipilimumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,opdivo, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.,opdivo, as monotherapy, is indicated for the treatment of patients with advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy.,classical hodgkin lymphoma (chl),opdivo, as monotherapy, is indicated for the treatment of patients with relapsed or refractory classical hodgkin lymphoma (chl) after autologous stem cell transplant and treatment with brentuximab vedotin. the approval of this indication is based on objective response rate in a single arm study.,squamous cell carcinoma of the head and neck (scchn),opdivo, as monotherapy, is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in patients progressing on or after platinum based therapy.,urothelial carcinoma (uc),opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with muscle invasive urothelial carcinoma (miuc) who are at high risk of recurrence after undergoing radical resection of miuc.,opdivo, as monotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. the approval of this indication is based on objective response rate and duration of response in a single arm study.,hepatocellular carcinoma (hcc),opdivo, as monotherapy, is indicated for the treatment of patients with hepatocellular carcinoma after prior sorafenib therapy. this indication is approved based on objective response rate and duration of response in a single arm study. an improvement in survival or disease-related symptoms has not been established.,oesophageal squamous cell carcinoma (oscc),opdivo in combination with ipilimumab is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ? 1% as determined by a validated test.,opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ? 1% as determined by a validated test.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum based chemotherapy.,adjuvant oesophageal cancer (oc) or gastro-oesophageal junction cancer (gojc),opdivo, as monotherapy, is indicated for the adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer in patients who have received neoadjuvant chemoradiotherapy.,gastric cancer (gc), gastro-oesophageal junction cancer (gojc), or oesophageal adenocarcinoma (oac),opdivo, in combination with fluoropyrimidine- and platinum-based combination chemotherapy, is indicated for the first-line treatment of patients with her2 negative advanced or metastatic gastric or gastro-oesophageal junction or oesophageal adenocarcinoma.

Israel - English - Ministry of Health

j-c health care ltd - erdafitinib - film coated tablets - erdafitinib 3 mg - erdafitinib - balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (muc), that has:- susceptible fgfr3 or fgfr2 genetiic alterations, and- progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Israel - English - Ministry of Health

j-c health care ltd - erdafitinib - film coated tablets - erdafitinib 4 mg - erdafitinib - balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (muc), that has:- susceptible fgfr3 or fgfr2 genetiic alterations, and- progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Israel - English - Ministry of Health

j-c health care ltd - erdafitinib - film coated tablets - erdafitinib 5 mg - erdafitinib - balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (muc), that has:- susceptible fgfr3 or fgfr2 genetiic alterations, and- progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.