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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,advanced gastric cancer,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatmen

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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 440 mg - injection, powder for - excipient ingredients: histidine hydrochloride; histidine; polysorbate 20; trehalose dihydrate - early breast cancer herzuma? is indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer herzuma? is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant herzuma?.,metastatic breast cancer herzuma? is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or c) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormonereceptor positive metastatic breast cancer.,advanced gastric cancer herzuma? is indicated in combination with cisplatin and either capecitabine or 5-fu for the treatment of patients with her2 positive advanced adenocarcinoma of the stomach or gastro- oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

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

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

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

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

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

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

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

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

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

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

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

guerbet australia pty ltd - ioversol, quantity: 678 mg/ml (equivalent: iodine, qty 320 mg/ml) - injection, solution - excipient ingredients: trometamol; sodium calcium edetate; water for injections; trometamol hydrochloride; sodium hydroxide - this product accepted for registration as 'currently supplied' at the time of commencement of the act. indications approved as specified in the letter of 19 april 1993 from dr h. arora are as follows: optiray is indicated in adults for angiography throughout the cardiovascular system by conventional or digital subtraction techniques. these include cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. optiray may be used in intravenous excretory urography. optiray 320 is indicated in children (excluding neonates) for angiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

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

dr reddys laboratories australia pty ltd - pemetrexed disodium -

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

bristol-myers squibb australia pty ltd - nivolumab, quantity: 107 mg - injection, concentrated - excipient ingredients: sodium citrate dihydrate; pentetic acid; mannitol; sodium chloride; polysorbate 80; sodium hydroxide; water for injections; hydrochloric acid - 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.