New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - nivolumab 10 mg/ml;  ;  ;   - concentrate for infusion - 100 mg/10ml - active: nivolumab 10 mg/ml       excipient: hydrochloric acid mannitol pentetic acid polysorbate 80 sodium chloride sodium citrate dihydrate sodium hydroxide water for injection - opdivo, as monotherapy is indicated for the treatment of patients with unresectable or metastatic melanoma. opdivo, in combination with yervoy (ipilimumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - nivolumab 10 mg/ml;  ;  ;   - concentrate for infusion - 40 mg/4ml - active: nivolumab 10 mg/ml       excipient: hydrochloric acid mannitol pentetic acid polysorbate 80 sodium chloride sodium citrate dihydrate sodium hydroxide water for injection - opdivo, as monotherapy is indicated for the treatment of patients with unresectable or metastatic melanoma. opdivo, in combination with yervoy (ipilimumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

bristol-myers squibb pharmaceuticals uc - paracetamol - solution for infusion - 10 mg/ml - analgesics and antipyretics

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

bristol-myers squibb australia pty ltd - aripiprazole -

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

bristol-myers squibb australia pty ltd - entecavir monohydrate -

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

bristol-myers squibb australia pty ltd - exenatide -

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

bristol-myers squibb australia pty ltd - exenatide -

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

bristol-myers squibb australia pty ltd - lomustine -