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

bristol-myers squibb australia pty ltd - lomustine -

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

bristol-myers squibb australia pty ltd - lomustine, quantity: 40 mg - capsule, hard - excipient ingredients: gelatin; indigo carmine; magnesium stearate; mannitol; titanium dioxide; iron oxide yellow; butan-1-ol; shellac; iron oxide black - (1) brain tumours (primary and secondary). (2) hodgkin's disease (as secondary therapy). lomustine is used in addition to appropriate surgical and/or radiotherapeutic procedures or as a component of various chemotherapeutic regimens in the palliative treatment of primary and metastatic brain tumours. ceenu containing combinations should be used as alternative therapy in the treatment of disseminated hodgkin's disease in patients refractory to other established treatment regimens.

New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - atazanavir sulfate 113.9mg equivalent to 100 mg atazanavir;   - capsule - 100 mg - active: atazanavir sulfate 113.9mg equivalent to 100 mg atazanavir   excipient: capsugel blue 3546 capsugel blue g2hcsrr0358 capsule white 0999 crospovidone lactose monohydrate magnesium stearate opacode white s-1-7085 - reyataz is indicated for the treatment of hiv 1 infection, in combination with other antiretroviral agents. this indication is based on analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled studies.

New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - atazanavir sulfate 170.84mg equivalent to 150 mg atazanavir - capsule - 150 mg - active: atazanavir sulfate 170.84mg equivalent to 150 mg atazanavir excipient: capsugel blue 2614 capsugel blue 3546 capsugel blue g1hcsrr0484 crospovidone lactose monohydrate magnesium stearate opacode white s-1-7085 - reyataz is indicated for the treatment of hiv 1 infection, in combination with other antiretroviral agents. this indication is based on analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled studies.

New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - atazanavir sulfate 227.79mg equivalent to 200 mg atazanavir - capsule - 200 mg - active: atazanavir sulfate 227.79mg equivalent to 200 mg atazanavir excipient: capsugel blue 3546 capsugel blue g0hcsrr0655 crospovidone lactose monohydrate magnesium stearate opacode white s-1-7085 - reyataz is indicated for the treatment of hiv 1 infection, in combination with other antiretroviral agents. this indication is based on analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled studies.

New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - atazanavir sulfate 341.69mg equivalent to 300 mg atazanavir - capsule - 300 mg - active: atazanavir sulfate 341.69mg equivalent to 300 mg atazanavir excipient: capsugel blue 3546 capsugel red 5226 crospovidone gelatin   indigo carmine processing aid processing aid iron oxide black iron oxide red iron oxide yellow lactose monohydrate magnesium stearate titanium dioxide   - reyataz is indicated for the treatment of hiv 1 infection, in combination with other antiretroviral agents. this indication is based on analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled studies.

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%.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - nivolumab - concentrate for solution for infusion - nivolumab 10 mg/ml - nivolumab - unresectable or metastatic melanoma:opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and pediatric patients 12 years and older.adjuvant treatment of melanoma:opdivo is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage iib, iic, iii, or iv melanoma.metastatic non-small cell lung cancer:- opdivo, in combination with ipilimumab 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.- opdivo is indicated for the treatment of adult patients with metastatic non small cell lung cancer (nsclc) with progression on or after platinum-based chemotherapy.renal cell carcinoma:- opdivo as a single agent is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) in patients who have received prior anti-angiogenic therapy.- opdivo in combination with ipilimumab is indicated for the first line treatment of adult patients with intermediate or poor risk, advanced renal cell carcinoma (rcc).- opdivo, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced rcc.classical hodgkin lymphoma:opdivo is indicated for the treatment of adult patients with classical hodgkin lymphoma (chl) that has relapsed or progressed after:* autologous hematopoietic stem cell transplantation (hsct) and brentuximab vedotin, or* 3 or more lines of systemic therapy that includes autologous hsct.squamous cell carcinoma of the head and neck:opdivo is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (scchn) with disease progression on or after platinum-based therapy.microsatellite instability-high (msi-h) or mismatch repair deficient(dmmr) metastatic colorectal cancer:opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years 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.urothelial carcinoma:- opdivo is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (uc) who are at high risk of recurrence after undergoing radical resection of uc.- opdivo (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: * have disease progression during or following platinum-containing chemotherapy * have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.hepatocellular carcinoma:opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult patients with hepatocellular carcinoma (hcc) child-pugh a who have been previously treated with sorafenib.esophageal cancer:-opdivo is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (crt). -opdivo is indicated for the treatment of adult patients with unresectable, advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.- opdivo in combination with ipilimumab 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%.-opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy 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%.malignant pleural mesothelioma:opdivo, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma:opdivo, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.neoadjuvant treatment of resectable non-small cell lung cancer:opdivo, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (nsclc).

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - fedratinib as dihydrochloride monohydrate - capsules - fedratinib as dihydrochloride monohydrate 100 mg - fedratinib - inrebic® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (mf)

Egypt - English - EDA (Egyptian Drug Authority)

bristol-myers squibb-egypt - capsule - 400 i.u.