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

sun pharma anz pty ltd - octreotide, quantity: 50 microgram - injection, solution - excipient ingredients: water for injections; sodium chloride; glacial acetic acid; sodium acetate trihydrate - for symptomatic control and reduction of growth hormone and igf-l plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment. octreotide treatment is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,for the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: - carcinoid tumours with features of the carcinoid syndrome - vasoactive intestinal peptide secreting tumours [vipomas] octreotide is not curative in these patients.,for reduction of the incidence of complications following pancreatic surgery.

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

sun pharma anz pty ltd - octreotide, quantity: 100 microgram - injection, solution - excipient ingredients: water for injections; sodium chloride; sodium acetate trihydrate; glacial acetic acid - for symptomatic control and reduction of growth hormone and igf-l plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment. octreotide treatment is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,for the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: - carcinoid tumours with features of the carcinoid syndrome - vasoactive intestinal peptide secreting tumours [vipomas] octreotide is not curative in these patients.,for reduction of the incidence of complications following pancreatic surgery.

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

sun pharma anz pty ltd - octreotide, quantity: 500 microgram - injection, solution - excipient ingredients: water for injections; sodium acetate trihydrate; glacial acetic acid; sodium chloride - for symptomatic control and reduction of growth hormone and igf-l plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment. octreotide treatment is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,for the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: - carcinoid tumours with features of the carcinoid syndrome - vasoactive intestinal peptide secreting tumours [vipomas] octreotide is not curative in these patients.,for reduction of the incidence of complications following pancreatic surgery.

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

link medical products pty ltd t/a link pharmaceuticals - aminolevulinic acid hydrochloride, quantity: 10.2 mg (equivalent: aminolevulinic acid, qty 8 mg) - patch, dermal - excipient ingredients: polyethylene terephthalate; polyethylene; aluminium; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - treatment of mild to moderate actinic keratoses (ak) lesions on the face and scalp (hairless areas).

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

maxx pharma pty ltd - bevacizumab, quantity: 100 mg - injection, concentrated - excipient ingredients: dibasic sodium phosphate; polysorbate 20; monobasic sodium phosphate dihydrate; water for injections; trehalose dihydrate; sodium hydroxide; phosphoric acid - metastatic colorectal cancer,abevmy (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.,locally recurrent or metastatic breast cancer,abevmy (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 pharmacodynamic properties, clinical trials).,advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc),abevmy (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for firstline treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non- small cell lung cancer.,advanced and/or metastatic renal cell cancer,abevmy (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer.,grade iv glioma,abevmy (bevacizumab) as a single agent, is indicated for the treatment of patients with grade iv glioma after relapse or disease progression after standard therapy, including chemotherapy.,epithelial ovarian, fallopian tube or primary peritoneal cancer,abevmy (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for firstline treatment of patients with advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer.,recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer,abevmy (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other vegf-targeted angiogenesis inhibitors.,abevmy (bevacizumab) in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab.,cervical cancer,abevmy (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. abevmy (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

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

maxx pharma pty ltd - bevacizumab, quantity: 400 mg - injection, concentrated - excipient ingredients: monobasic sodium phosphate dihydrate; trehalose dihydrate; water for injections; polysorbate 20; dibasic sodium phosphate; sodium hydroxide; phosphoric acid - metastatic colorectal cancer,abevmy (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.,locally recurrent or metastatic breast cancer,abevmy (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 pharmacodynamic properties, clinical trials).,advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc),abevmy (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for firstline treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non- small cell lung cancer.,advanced and/or metastatic renal cell cancer,abevmy (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer.,grade iv glioma,abevmy (bevacizumab) as a single agent, is indicated for the treatment of patients with grade iv glioma after relapse or disease progression after standard therapy, including chemotherapy.,epithelial ovarian, fallopian tube or primary peritoneal cancer,abevmy (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for firstline treatment of patients with advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer.,recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer,abevmy (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other vegf-targeted angiogenesis inhibitors.,abevmy (bevacizumab) in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab.,cervical cancer,abevmy (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. abevmy (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

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

pfizer australia pty ltd - raltitrexed, quantity: 2 mg - injection, powder for - excipient ingredients: sodium hydroxide; mannitol; dibasic sodium phosphate dodecahydrate - for use as a single agent in the palliative treatment of advanced colorectal cancer (distant metastases or unresectable local disease).

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

sun pharma anz pty ltd - pantoprazole sodium, quantity: 42.29 mg (equivalent: pantoprazole, qty 40 mg) - injection, powder for - excipient ingredients: - short-term use where oral therapy is not appropriate for the following conditions. 1. symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion, e.g. duodenal ulcer, gastric ulcer, reflux oesophagitis, gastrointestinal lesions refractory to h2 blockers, zollinger-ellison syndrome. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.,note: patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to anti-secretory drugs, whether on first presentation or recurrence.

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

eisai new zealand limited - lenvatinib mesilate 12.25mg equivalent to lenvatinib 10mg - capsule - 10 mg - active: lenvatinib mesilate 12.25mg equivalent to lenvatinib 10mg excipient: calcium carbonate hyprolose as 25mg low-substituted hydroxypropyl cellulose + 3mg hydroxypropylcellulose hypromellose iron oxide black iron oxide red iron oxide yellow mannitol microcrystalline cellulose potassium hydroxide propylene glycol purified talc shellac titanium dioxide - lenvima is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine refractory differentiated thyroid cancer.

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

eisai new zealand limited - lenvatinib mesilate 4.9mg equivalent to lenvatinib 4mg - capsule - 4 mg - active: lenvatinib mesilate 4.9mg equivalent to lenvatinib 4mg excipient: calcium carbonate hyprolose as 25mg low-substituted hydroxypropyl cellulose + 3mg hydroxypropylcellulose hypromellose iron oxide black iron oxide red iron oxide yellow mannitol microcrystalline cellulose potassium hydroxide propylene glycol purified talc shellac titanium dioxide - lenvima is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine refractory differentiated thyroid cancer.