Israel - English - Ministry of Health

merck serono ltd - cetuximab - solution for infusion - cetuximab 5 mg/ml - cetuximab - cetuximab - erbitux® is indicated for the treatment of patients with epidermal growth factor receptor (egfr) - expressing, ras wild-type metastatic colorectal cancer• in combination with irinotecan-based chemotherapy• in first-line in combination with folfox• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecanerbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck (scchn)• in combination with radiation therapy for locally advanced disease• in combination with platinum-based chemotherapy for recurrent and/or metastatic disease• as a single agent after failure of platinum-based chemotherapy for recurrent and/or metastatic disease

Ireland - English - HPRA (Health Products Regulatory Authority)

cipla (eu) limited - montelukast sodium - film coated tablet - 10 milligram - leukotriene receptor antagonists - leukotriene receptor antagonist - it is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting
-agonists provide inadequate clinical control of asthma. in those asthmatic patients in whom montelukast is indicated in asthma, montelukast can also provide symptomatic relief of seasonal allergic rhinitis.

Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp & dohme ireland (human health) limited - montelukast sodium - film-coated tablet - 10 milligram(s) - leukotriene receptor antagonists; montelukast - leukotriene receptor antagonist - it is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting
- agonists provide inadequate clinical control of asthma. in those asthmatic patients in whom singulair is indicated in asthma, singulair can also provide symptomatic relief of seasonal allergic rhinitis. singulair is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - everolimus - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - antineoplastic agents - hormone-receptor-positive advanced breast cancerafinitor is indicated for the treatment of hormone-receptor-positive, her2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.neuroendocrine tumours of pancreatic originafinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.neuroendocrine tumours of gastrointestinal or lung originafinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.renal-cell carcinomaafinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.

European Union - English - EMA (European Medicines Agency)

merck europe b.v.  - cetuximab - head and neck neoplasms; colorectal neoplasms - antineoplastic agents - erbitux is indicated for the treatment of patients with epidermal growth factor receptor (egfr)-expressing, ras wild-type metastatic colorectal cancer:in combination with irinotecan-based chemotherapy;in first-line in combination with folfox;as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.for details, see section 5.1.erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck:in combination with radiation therapy for locally advanced disease;in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

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

roche products pty ltd - trastuzumab, quantity: 600 mg - injection, solution - excipient ingredients: vorhyaluronidase alfa; histidine hydrochloride monohydrate; histidine; trehalose dihydrate; methionine; polysorbate 20; water for injections - early breast cancer: herceptin sc is indicated for the treatment of her2-positive localised breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer: herceptin sc is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant herceptin.,metastatic breast cancer: herceptin sc is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,- as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,- in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,- in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.

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

merck healthcare pty ltd - cetuximab, quantity: 5 mg/ml - injection, intravenous infusion - excipient ingredients: citric acid monohydrate; water for injections; sodium chloride; sodium hydroxide; glycine; polysorbate 80 - erbitux is indicated for the treatment of patients with epidermal growth factor receptor (egfr)-expressing, ras wild-type metastatic colorectal cancer. in combination with infusional 5-fluorouracil/folinic acid plus irinotecan. in combination with irinotecan in patients who are refractory to first-line chemotherapy. in first-line in combination with folfox. as a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and irinotecan-based therapy. (see clinical trials) erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck. in combination with radiation therapy for locally advanced disease. in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

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

merck healthcare pty ltd - cetuximab, quantity: 5 mg/ml - injection, intravenous infusion - excipient ingredients: water for injections; citric acid monohydrate; polysorbate 80; sodium chloride; sodium hydroxide; glycine - erbitux is indicated for the treatment of patients with epidermal growth factor receptor (egfr)-expressing, ras wild-type metastatic colorectal cancer. in combination with infusional 5-fluorouracil/folinic acid plus irinotecan. in combination with irinotecan in patients who are refractory to first-line chemotherapy. in first-line in combination with folfox. as a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and irinotecan-based therapy. (see clinical trials) erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck. in combination with radiation therapy for locally advanced disease. in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

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

astrazeneca pty ltd - fulvestrant, quantity: 50 mg/ml - injection, solution - excipient ingredients: ethanol; benzyl alcohol; benzyl benzoate; castor oil - faslodex is indicated for the treatment of postmenopausal women with:,? hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, locally advanced or metastatic breast cancer who have not been previously treated with endocrine therapy.,? hr positive, locally advanced or metastatic breast cancer who have progressive disease following prior endocrine (anti-oestrogen or aromatase inhibitor) therapy.

European Union - English - EMA (European Medicines Agency)

eli lilly nederland b.v. - abemaciclib - breast neoplasms - antineoplastic agents - early breast cancerverzenios 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 (see section 5.1).in pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.advanced or metastatic breast cancerverzenios is indicated for the treatment of women with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.in pre- or perimenopausal women, the endocrine therapy should be combined with a lhrh agonist.