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 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.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

heiniger australia pty ltd - urogastrone epidermal growth factor (uro-egf) - parenteral liquid/solution/suspension - urogastrone epidermal growth factor (uro-egf) ungrouped active 7.5 mg/ml - endocrine system - sheep | ewe | hogget | lamb | ovine | ram | weaner | wether - wool shearing - biological

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

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - bevacizumab - concentrate for solution for infusion - bevacizumab 25 mg/ml - bevacizumab - bevacizumab - - avastin in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.- avastin in addition to platinum - based chemotherapy is indicated for first - line treatment of patients with unresectable advanced metastatic or recurrent non- small cell lung cancer other than predominantly squamous cell histology. - avastin in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and /or metastatic renal cell cancer. - avastin in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer.- avastin as asingle agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.- avastin, in combination with carboplatin and paclitaxel, is indicated for the front-line treatment of advanced (figo stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are at high risk for recurrence (residual disease after debulking).- avastin, in combination with carboplatin and gemcitabine, is indicated for the treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents.- avastin ( bevacizumab) in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents - avastin ( bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for treatment of patients with persistent, recurrent, or metastatic carcinoma of the cervix.- bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. - bevacizumab, in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (hcc) who have not received prior systemic 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.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig  - palbociclib - breast neoplasms - antineoplastic agents - ibrance is indicated for the treatment of hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer:in combination with an aromatase inhibitor;in combination with fulvestrant in women who have received prior endocrine therapy.in pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (lhrh) agonist.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - gefitinib - carcinoma, non-small-cell lung - antineoplastic agents - iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase.

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.

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

pfizer australia pty ltd - palbociclib, quantity: 100 mg - capsule, hard - excipient ingredients: magnesium stearate; iron oxide yellow; silicon dioxide; iron oxide red; microcrystalline cellulose; sodium starch glycollate type a; lactose monohydrate; titanium dioxide; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid - 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.