New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - ipilimumab 5 mg/ml;   - concentrate for injection - 200 mg/40 ml - active: ipilimumab 5 mg/ml   excipient: hydrochloric acid mannitol nitrogen pentetic acid polysorbate 80 sodium chloride sodium hydroxide trometamol hydrochloride water for injection - yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma in adults, 18 years of age or older. yervoy, in combination with opdivo (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic disease melanoma.

New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - ipilimumab 5 mg/ml;   - concentrate for injection - 50 mg/10 ml - active: ipilimumab 5 mg/ml   excipient: hydrochloric acid mannitol nitrogen pentetic acid polysorbate 80 sodium chloride sodium hydroxide trometamol hydrochloride water for injection - yervoy, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma in adults, 18 years of age or older. yervoy, in combination with opdivo (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic disease melanoma.

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.

United States - English - NLM (National Library of Medicine)

e.r. squibb & sons, l.l.c. - ipilimumab (unii: 6t8c155666) (ipilimumab - unii:6t8c155666) - ipilimumab 5 mg in 1 ml - yervoy, as a single agent or in combination with nivolumab, is indicated for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older. yervoy is indicated for the adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. yervoy, in combination with nivolumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (rcc). yervoy, in combination with nivolumab, 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 (mcrc) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. this indication is approved under accelerated approval based on overall response rate and duration of response [

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%.

New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - ipilimumab 5 mg/ml;   - concentrate for injection - 200 mg/40ml - active: ipilimumab 5 mg/ml   excipient: hydrochloric acid mannitol nitrogen pentetic acid polysorbate 80 sodium chloride sodium hydroxide trometamol hydrochloride water for injection - winglore as monotherapy, is indicated for the treatement of patients with unresectable or metastatic melanoma in adults, 18 years of age or older. winglore, in combination with opdivo (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic disease melanoma.

New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - ipilimumab 5 mg/ml;   - concentrate for injection - 50 mg/10ml - active: ipilimumab 5 mg/ml   excipient: hydrochloric acid mannitol nitrogen pentetic acid polysorbate 80 sodium chloride sodium hydroxide trometamol hydrochloride water for injection - winglore as monotherapy, is indicated for the treatement of patients with unresectable or metastatic melanoma in adults, 18 years of age or older. winglore, in combination with opdivo (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic disease melanoma.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

bristol-myers squibb, united states - ipilimumab - intravenous infusion - 5 mg/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

bristol-myers squibb - ipilimumab - intravenous infusion - 5 mg/ml