Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

ono pharmaceutical co., ltd. - nivolumab (genetical recombination) - injection

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

bristol-myers squibb - nivolumab (genetical recombination) - injection

Ireland - English - HPRA (Health Products Regulatory Authority)

norbrook laboratories limited - oxfendazole, cobaltous sulfate, selenium - oral suspension - 5 per cent - oxfendazole - ovine - endoparasiticide

Ireland - English - HPRA (Health Products Regulatory Authority)

norbrook laboratories limited - oxfendazole, cobaltous sulfate, selenium - oral suspension - 5 per cent - oxfendazole - ovine - endoparasiticide

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastic agents - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4). yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4.4 and 5.1).renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation.malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5.1).oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.

Singapore - English - HSA (Health Sciences Authority)

philips electronics singapore pte ltd - anaesthesiology - it is a portable medical device that is intended to aerosolize physician-prescribed solutions for inhalation to patients on ventilation or other positive pressure breathing assistance.

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

ipsen pty ltd - cabozantinib (s)-malate, quantity: 76.03 mg (equivalent: cabozantinib, qty 60 mg) - tablet, film coated - excipient ingredients: titanium dioxide; magnesium stearate; hypromellose; triacetin; colloidal anhydrous silica; iron oxide yellow; hyprolose; lactose; croscarmellose sodium; microcrystalline cellulose - 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.

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

bristol-myers squibb australia pty ltd - ipilimumab, quantity: 213 mg - injection, concentrated - excipient ingredients: trometamol hydrochloride; sodium chloride; mannitol; pentetic acid; polysorbate 80; sodium hydroxide; hydrochloric acid; water for injections - melanoma,yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,yervoy, 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),yervoy, 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),yervoy, 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),yervoy, in combination with nivolumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,oesophageal squamous cell carcinoma (oscc),yervoy 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.

Australia - English - 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,yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,yervoy, 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),yervoy, 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),yervoy, 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),yervoy, in combination with nivolumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,oesophageal squamous cell carcinoma (oscc),yervoy 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.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - ipilimumab - concentrate for solution for infusion - ipilimumab 5 mg/ml - ipilimumab - ipilimumab - unresectable or metastatic melanomayervoy (ipilimumab) is indicated for the treatment of adult patients with advanced (unresectable or metastatic) melanoma. yervoy in combination with nivolumab is indicated for the treatment of adult and pediatric patients 12 years and older with advanced (unresectable or metastatic) melanoma . advanced renal cell carcinomayervoy, in combination with nivolumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk, advanced renal cell carcinoma (rcc). microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) metastatic colorectal canceryervoy, in combination with nivolumab, is indicated for the treatment of adult and pediatric patients 12 years of age and older with microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) metastatic colorectal cancer (crc) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.metastatic non-small cell lung canceryervoy, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (nsclc) with no egfr or alk genomic tumor aberrations.hepatocellular carcinomayervoy, in combination with nivolumab, is indicated for the treatment of adult patients with hepatocellular carcinoma (hcc) child-pugh a who have been previously treated with sorafenib.malignant pleural mesotheliomayervoy, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesotheliomaesophageal canceryervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.