Australija - anglų - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 44.34 mg - tablet, film coated - excipient ingredients: crospovidone; titanium dioxide; polysorbate 80; lactose monohydrate; macrogol 400; colloidal anhydrous silica; microcrystalline cellulose; hypromellose; magnesium stearate; purified talc; indigo carmine aluminium lake - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 59.12 mg - tablet, film coated - excipient ingredients: titanium dioxide; macrogol 400; purified talc; crospovidone; lactose monohydrate; hypromellose; microcrystalline cellulose; indigo carmine aluminium lake; colloidal anhydrous silica; polysorbate 80; magnesium stearate - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - afatinib dimaleate, quantity: 29.56 mg - tablet, film coated - excipient ingredients: lactose monohydrate; polysorbate 80; magnesium stearate; macrogol 400; titanium dioxide; crospovidone; microcrystalline cellulose; colloidal anhydrous silica; hypromellose; purified talc - giotrif is indicated as monotherapy for the treatment of adult patients with:,? locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have activating epidermal growth factor receptor (egfr) mutations.,? locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

zo skin health, inc. - oatmeal (unii: 8pi54v663y) (oatmeal - unii:8pi54v663y) - oatmeal 10 mg in 1 ml - skin protectant temporarily protects and helps relieve minor skin irritation and itching due to: - rashes.

Australija - anglų - 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.

Australija - anglų - 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.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

zo skin health, inc. - oatmeal (unii: 8pi54v663y) (oatmeal - unii:8pi54v663y) - oatmeal 10 mg in 1 ml - skin protectant temporarily protects and helps relieve minor skin irritation and itching due to: - rashes.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ribociclib succinate, quantity: 254.4 mg (equivalent: ribociclib, qty 200 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; hyprolose; crospovidone; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin; iron oxide black; iron oxide red - kisqali is indicated for the treatment of patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer, in combination with an aromatase inhibitor or fulvestrant, as initial endocrine-based therapy or following prior endocrine therapy.

Izraelis - anglų - Ministry of Health

astrazeneca (israel) ltd - olaparib - film coated tablets - olaparib 100 mg - olaparib - ovarian cancer:lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (figo stages iii and iv) brca1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.first-line maintenance treatment of advanced ovarian cancer in combination with bevacizumablynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either:• a deleterious or suspected deleterious brca mutation, and/or• genomic instability breast cancer:germline brca-mutated her2-negative metastatic breast cancerlynparza is indicated in patients with deleterious or suspected deleterious gbrcam, her2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. patients with hormone receptor (hr)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.adjuvant treatment of germline brca-mutated her2-negative high risk early breast cancer lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gbrcam human epidermal growth factor receptor 2 (her2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. adenocarcinoma of the pancreas:first-line maintenance treatment of germline brca-mutated metastatic pancreatic adenocarcinomalynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.prostate cancer:• germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer (mcrpc) who have progressed following prior treatment with enzalutamide or abiraterone.• lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious hrr-mutated (hrrm) metastatic castration-resistant prostate cancer (mcrpc). select patients for therapy based on an approved companion diagnostic for lynparza

Izraelis - anglų - Ministry of Health

astrazeneca (israel) ltd - olaparib - film coated tablets - olaparib 100 mg - olaparib - ovarian cancer:lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (figo stages iii and iv) brca1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.first-line maintenance treatment of advanced ovarian cancer in combination with bevacizumablynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either:• a deleterious or suspected deleterious brca mutation, and/or• genomic instability breast cancer:germline brca-mutated her2-negative metastatic breast cancerlynparza is indicated in patients with deleterious or suspected deleterious gbrcam, her2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. patients with hormone receptor (hr)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.adjuvant treatment of germline brca-mutated her2-negative high risk early breast cancer lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gbrcam human epidermal growth factor receptor 2 (her2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. adenocarcinoma of the pancreas:first-line maintenance treatment of germline brca-mutated metastatic pancreatic adenocarcinomalynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.prostate cancer:germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancerlynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer (mcrpc) who have progressed following prior treatment with enzalutamide or abiraterone.