Австралия - английский - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - ipilimumab, quantity: 53.5 mg - injection, concentrated - excipient ingredients: trometamol hydrochloride; sodium chloride; mannitol; pentetic acid; polysorbate 80; sodium hydroxide; hydrochloric acid; water for injections - melanoma,winglore, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,winglore, in combination with nivolumab, 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.,renal cell carcinoma (rcc),winglore, in combination with nivolumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,non-small cell lung cancer (nsclc),winglore, in combination with nivolumab 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.,malignant pleural mesothelioma (mpm),winglore, in combination with nivolumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,oesophageal squamous cell carcinoma (oscc),winglore in combination with nivolumab 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 greater than or equal to 1% as determined by a validated test.

Соединенные Штаты - английский - NLM (National Library of Medicine)

exelixis, inc. - cabozantinib s-malate (unii: dr7st46x58) (cabozantinib - unii:1c39jw444g) - cabozantinib 60 mg - cabometyx is indicated for the treatment of patients with advanced renal cell carcinoma (rcc). cabometyx, in combination with nivolumab, is indicated for the first-line treatment of patients with advanced rcc. cabometyx is indicated for the treatment of patients with hepatocellular carcinoma (hcc) who have been previously treated with sorafenib. cabometyx is indicated for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (dtc) that has progressed following prior vegfr-targeted therapy and who are radioactive iodine-refractory or ineligible. none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , cabometyx can cause fetal harm when administered to a pregnant woman. there are no available data in pregnant women to inform the drug-associated risk. in animal developmental and reproductive toxicology studies administration of cabozantinib to pregnant rats and rab

Ирландия - английский - HPRA (Health Products Regulatory Authority)

kora corporation limited trading as kora healthcare - magnesium - tablet - 97 milligram(s) - magnesium citrate

Сингапур - английский - HSA (Health Sciences Authority)

bristol-myers squibb (singapore) pte. ltd. - ipilimumab - injection, solution, concentrate - 5g - ipilimumab 5mg/ml

Сингапур - английский - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - pathology - pd-l1 ihc 28-8 pharmdx is a qualitative immunohistochemical assay using monoclonal rabbit anti-pd-l1, clone 28-8 intended for use in the detection of pd-l1 protein in formalin-fixed, paraffin-embedded (ffpe) non-squamous non-small cell lung cancer (nsnsclc) and muscle invasive urothelial carcinoma (miuc) tissues using envision flex visualization system on autostainer link 48. pd-l1 protein expression in nsnsclc and miuc is determined by using % tumor cell expression, which is the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity. pd-l1 ihc 28-8 pharmdx is indicated as an aid in identifying miuc patients with ≥ 1% tumor cell pd-l1 expression for treatment with opdivo® (nivolumab). pd-l1 expression (≥ 1% or ≥ 5% or ≥ 10% tumor cell expression), as detected by pd-l1 ihc 28-8 pharmdx in non-squamous nsclc (nsnsclc) may be associated with enhanced survival from opdivo® (nivolumab).

Австралия - английский - Department of Health (Therapeutic Goods Administration)

agilent technologies australia pty ltd - ct1056 - immunohistology cell marker ivds - pd-l1 ihc 28-8 pharmdx is a qualitative immunohistochemical assay using monoclonal rabbit anti-pd-l1, clone 28-8 intended for use in the detection of pd-l1 protein in formalin-fixed, paraffin-embedded (ffpe) cancer tissues using envision flex visualization system on autostainer link 48. pd-l1 ihc 28-8 pharmdx is a qualitative immunohistochemical assay using monoclonal rabbit anti-pd-l1, clone 28-8 intended for use in the detection of pd-l1 protein in formalin-fixed, paraffin-embedded (ffpe) non-squamous non-small cell lung cancer (nsnsclc), melanoma, and esophageal squamous cell carcinoma (escc) tissues. it is indicated as an aid in identifying escc patients with tumour cell pd-l1 expression ? 1% for treatment with opdivo? (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy or opdivo? (nivolumab) in combination with yervoy? (ipilimumab).

Соединенные Штаты - английский - NLM (National Library of Medicine)

celtic biotech iowa, inc. - crotalus durissus terrificus venom (unii: 2xf6i0446g) (crotalus durissus terrificus venom - unii:2xf6i0446g), cardiotoxin iii (unii: 0qbh3y8m6j) (cardiotoxin iii - unii:0qbh3y8m6j) - crotalus durissus terrificus venom 4 [hp_x] in 1 ml - according to the fda reference text “clarkes’ materia medica 1900”; crotalus venom preparations are indicated as homeopathic medications for numerous conditions but especially; cancers. tongue, inflammation of ; cancer of. clinical experience shows that crotoxin also provide relief from some forms of pain. cobra venom preparations are indicated as homeopathic medications for several conditions but especially for; angina faucium, angina pectoris, asthma, dysmenia (painful menses), grief (depression), headache (migraine), pain in ovaries (ovarian cysts), spinal irritation (back pain) and sore throat. cardiotoxin is the principal active analgesic component. ctc-310 is intended to be used as a monotherapy. clinical experience suggests that concurrent use of radio- or chemotherapy may inhibit the activity of the drug. as the known receptors include those sensitive to nicotine is it is likely that nicotine will inhibit the activity of crotoxin.

Соединенные Штаты - английский - NLM (National Library of Medicine)

celtic biotech iowa, inc. - crotalus durissus terrificus venom (unii: 2xf6i0446g) (crotalus durissus terrificus venom - unii:2xf6i0446g) - crotalus durissus terrificus venom 4 [hp_x] in 1 ml - according to clarkes’s materia medica, crotalus venom preparations are indicated as homeopathic medications for; amblyopia. apoplexy. appendicitis. bilious fever. boils. cancers. carbuncles. cerebro-spinal meningitis. chancre. ciliary neuralgia. convulsions. delirium tremens. dementia. diphtheria. dysmenorrhoea. dyspepsia. ears, discharges from. ecchymosis. epilepsy. eyes, affections of. erysipelas, face, eruption on ; distortion of. haematuria. hemorrhagic diathesis. headache. heart, affections of. herpes. hydrophobia. intestinal haemorrhage. jaundice. keratitis. liver, disorders of. lungs, affections of, mastitis. measles. milk-leg. meningitis. ovaries, affections of. ozaena, palpitation. peritonitis. perityphlitis. phlebitis. psoriasis palmaris. purpura. pyaemia. remittent fever. rheumatism. scarlatina. sleeplessness. small-pox. stings. sunstroke. syphilis. tetanus. thirst. tongue, inflammation of ; cancer of. ulcers. urticaria. vaccination, effects of. varicosis. varicocele. vomiting, bilious. white-leg.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - cabozantinib (s)-malate, quantity: 50.69 mg (equivalent: cabozantinib, qty 40 mg) - tablet, film coated - excipient ingredients: lactose; microcrystalline cellulose; hypromellose; croscarmellose sodium; iron oxide yellow; hyprolose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; triacetin - renal cell carcinoma (rcc),cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):,- in treatment-na?ve adults with intermediate or poor risk,- in adults following prior treatment with vascular endothelial growth factor targeted therapy.,cabometyx in combination with nivolumab is indicated for the first-line treatment of advanced renal cell carcinoma.,hepatocellular carcinoma (hcc),cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.,differentiated thyroid carcinoma (dtc),cabometyx is indicated as monotherapy for the treatment of adult and paediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid carcinoma (dtc) that has progressed during or after prior vegfr-targeted therapy and who are radioactive iodine (rai) refractory or ineligible.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - cabozantinib (s)-malate, quantity: 25.34 mg (equivalent: cabozantinib, qty 20 mg) - tablet, film coated - excipient ingredients: magnesium stearate; triacetin; titanium dioxide; lactose; microcrystalline cellulose; colloidal anhydrous silica; hyprolose; croscarmellose sodium; hypromellose; iron oxide yellow - renal cell carcinoma (rcc),cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):,- in treatment-na?ve adults with intermediate or poor risk,- in adults following prior treatment with vascular endothelial growth factor targeted therapy.,cabometyx in combination with nivolumab is indicated for the first-line treatment of advanced renal cell carcinoma.,hepatocellular carcinoma (hcc),cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.,differentiated thyroid carcinoma (dtc),cabometyx is indicated as monotherapy for the treatment of adult and paediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid carcinoma (dtc) that has progressed during or after prior vegfr-targeted therapy and who are radioactive iodine (rai) refractory or ineligible.