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

bristol-myers squibb australia pty ltd - naltrexone hydrochloride -

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

bristol-myers squibb australia pty ltd - nivolumab, quantity: 250 mg - injection, solution - excipient ingredients: sodium citrate dihydrate; sodium chloride; mannitol; pentetic acid; polysorbate 80; hydrochloric acid; sodium hydroxide; water for injections - melanoma,opdivo, as monotherapy, is indicated for the adjuvant treatment of adults and adolescent patients 12 years and older with completely resected stage iib, iic, iii or iv melanoma.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,opdivo, in combination with ipilimumab, 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.,non-small cell lung cancer (nsclc),opdivo, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (nsclc).,opdivo, in combination with ipilimumab 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.,opdivo, as monotherapy, is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (nsclc) with progression on or after prior chemotherapy.,opdivo, as monotherapy, is indicated for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsclc) with progression on or after prior chemotherapy. in patients with tumour egfr or alk genomic aberrations, opdivo should be used after progression on or after targeted therapy.,malignant pleural mesothelioma (mpm),opdivo, in combination with ipilimumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,renal cell carcinoma (rcc),opdivo, in combination with ipilimumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,opdivo, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.,opdivo, as monotherapy, is indicated for the treatment of patients with advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy.,classical hodgkin lymphoma (chl),opdivo, as monotherapy, is indicated for the treatment of patients with relapsed or refractory classical hodgkin lymphoma (chl) after autologous stem cell transplant and treatment with brentuximab vedotin. the approval of this indication is based on objective response rate in a single arm study.,squamous cell carcinoma of the head and neck (scchn),opdivo, as monotherapy, is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in patients progressing on or after platinum based therapy.,urothelial carcinoma (uc),opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with muscle invasive urothelial carcinoma (miuc) who are at high risk of recurrence after undergoing radical resection of miuc.,opdivo, as monotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. the approval of this indication is based on objective response rate and duration of response in a single arm study.,hepatocellular carcinoma (hcc),opdivo, as monotherapy, is indicated for the treatment of patients with hepatocellular carcinoma after prior sorafenib therapy. this indication is approved based on objective response rate and duration of response in a single arm study. an improvement in survival or disease-related symptoms has not been established.,oesophageal squamous cell carcinoma (oscc),opdivo in combination with ipilimumab 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 ? 1% as determined by a validated test.,opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy 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 ? 1% as determined by a validated test.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum based chemotherapy.,adjuvant oesophageal cancer (oc) or gastro-oesophageal junction cancer (gojc),opdivo, as monotherapy, is indicated for the adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer in patients who have received neoadjuvant chemoradiotherapy.,gastric cancer (gc), gastro-oesophageal junction cancer (gojc), or oesophageal adenocarcinoma (oac),opdivo, in combination with fluoropyrimidine- and platinum-based combination chemotherapy, is indicated for the first-line treatment of patients with her2 negative advanced or metastatic gastric or gastro-oesophageal junction or oesophageal adenocarcinoma.

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - stavudine 15mg - capsule - 15 mg - active: stavudine 15mg excipient: gelatin lactose lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - zerit (stavudine) is indicated for the treatment of hiv infection in adults and paediatric patients, in combination with other anti-retrovirals.

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - stavudine 20mg - capsule - 20 mg - active: stavudine 20mg excipient: gelatin lactose lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - zerit (stavudine) is indicated for the treatment of hiv infection in adults and paediatric patients, in combination with other anti-retrovirals.

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - stavudine 30mg - capsule - 30 mg - active: stavudine 30mg excipient: gelatin lactose lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - zerit (stavudine) is indicated for the treatment of hiv infection in adults and paediatric patients, in combination with other anti-retrovirals.

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - stavudine 40mg - capsule - 40 mg - active: stavudine 40mg excipient: gelatin lactose lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - zerit (stavudine) is indicated for the treatment of hiv infection in adults and paediatric patients, in combination with other anti-retrovirals.

Irlanda - inglés - HPRA (Health Products Regulatory Authority)

bristol-myers squibb (holdings) limited - etoposide - capsules, soft - 100 milligram - podophyllotoxin derivatives

Irlanda - inglés - HPRA (Health Products Regulatory Authority)

bristol-myers squibb (holdings) limited - etoposide - capsule - 50 mg milligram - podophyllotoxin derivatives

Unión Europea - inglés - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - clopidogrel (as hydrogen sulfate) - stroke; peripheral vascular diseases; myocardial infarction; acute coronary syndrome - antithrombotic agents - clopidogrel is indicated in adults for the prevention of atherothrombotic events in:- patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.- patients suffering from acute coronary syndrome:non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa).st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy.

Unión Europea - inglés - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - irbesartan - hypertension - agents acting on the renin-angiotensin system - treatment of essential hypertension.treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).