Малайзия - английски - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

cta nutriceuticals (asia) sdn bhd - glutamine; l-phenylalanine -

Австралия - английски - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty limited - phenylalanine; tryptophan; alanine; glycylglutamine monohydrate; valine; aspartic acid; serine; glutamic acid; glycyltyrosine dihydrate; histidine; leucine; isoleucine; methionine; lysine acetate; proline; threonine; arginine -

Нова Зеландия - английски - Medsafe (Medicines Safety Authority)

boucher & muir (new zealand) limited t/a bnm group - amiodarone hydrochloride 50 mg/ml - concentrate for injection - 50 mg/ml - active: amiodarone hydrochloride 50 mg/ml excipient: benzyl alcohol hydrochloric acid polysorbate 80 sodium hydroxide water for injection - treatment should be initiated only under hospital or specialist supervision. indicated for treatment of · tachyarrhythmias associated with wolff-parkinson-white syndrome. · all types of tachyarrhythmias including · supraventricular, nodal and ventricular tachycardias, atrial flutter and fibrillation; · ventricular fibrillation; · when other agents cannot be used. the injection is to be used when a rapid response is required.

Нова Зеландия - английски - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - eltrombopag olamine 31.9mg equivalent to eltrombopag 25 mg;   - film coated tablet - 25 mg - active: eltrombopag olamine 31.9mg equivalent to eltrombopag 25 mg   excipient: magnesium stearate mannitol microcrystalline cellulose opadry white ys-1-7706-g povidone sodium starch glycolate - revolade is indicated for the treatment of adult patients with immune thrombocytopenia (itp) who have had an inadequate response or are intolerant to corticosteroids and immunoglobulins.

Израел - английски - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - fluconazole - powder for suspension - fluconazole 50 mg / 5 ml - fluconazole - fluconazole - fluconazole is indicated in the following fungal infections.fluconazole is indicated in adults for the treatment of:• cryptococcal meningitis.• coccidioidomycosis.• invasive candidiasis.• mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.• chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.• vaginal candidiasis, acute or recurrent; when local therapy is not appropriate.• candidal balanitis when local therapy is not appropriate.• dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.• tinea unguinium (onychomycosis) when other agents are not considered appropriate.fluconazole is indicated in adults for the prophylaxis of:• relapse of cryptococcal meningitis in patients with high risk of recurrence.• relapse of oropharyngeal or oesophageal candidiasis in patients infected with hiv who are at high risk of experiencing relapse.• to reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year).• prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving hematopoietic stem cell transplantation).fluconazole is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old:fluconazole is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti infective therapy should be adjusted accordingly.consideration should be given to official guidance on the appropriate use of antifungals.

Ирландия - английски - HPRA (Health Products Regulatory Authority)

fresenius kabi oncology plc - etoposide - concentrate for solution for infusion - 20 milligram(s)/millilitre - podophyllotoxin derivatives; etoposide

Ирландия - английски - HPRA (Health Products Regulatory Authority)

rowex ltd - fluconazole - solution for infusion - 2 milligram(s)/millilitre - triazole derivatives; fluconazole

Ирландия - английски - HPRA (Health Products Regulatory Authority)

claris lifesciences (uk) limited - fluconazole - solution for infusion - 2 milligram(s)/millilitre - triazole derivatives; fluconazole

Сингапур - английски - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - clofarabine - solution, concentrate - 1mg/ml - clofarabine 1mg/ml

Австралия - английски - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - nivolumab, quantity: 107 mg - injection, concentrated - excipient ingredients: sodium citrate dihydrate; pentetic acid; mannitol; sodium chloride; polysorbate 80; sodium hydroxide; water for injections; hydrochloric acid - 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.