Malaysia - engelska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

idaman pharma manufacturing sdn bhd - gliclazide -

Australien - engelska - Department of Health (Therapeutic Goods Administration)

interpharma pty ltd - bortezomib, quantity: 3.5 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections; mannitol - bortezomib ever pharma, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. bortezomib ever pharma, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. bortezomib ever pharma is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib ever pharma in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

interpharma pty ltd - bortezomib, quantity: 2.5 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections; mannitol - bortezomib ever pharma, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. bortezomib ever pharma, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. bortezomib ever pharma is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib ever pharma in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Israel - engelska - Ministry of Health

ofek pharma ltd, israel - posaconazole - tablets delayed release - posaconazole 100 mg - posaconazole - treatment of the following fungal infections in adults:- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b.- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patient intolerant to itraconazole.- coccidioidomycosis in patients with disease refractory to amphotericin b, itraconazole or fludonazole or in patient intolerant to these medicinal products.- zygomycosis in patients intolerant of or with disease that is refractory to alternative therapy.refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.these are also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukemia (aml) or myelodysplatic syndrome (mds) expected to result in prolonged neutropenia who are at high-risk of developing invasive fungal infections.-hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high-risk of developing invasive fungal infections.

Singapore - engelska - HSA (Health Sciences Authority)

qt instruments (s) pte ltd - bicisate dihydrochloride (ecd.2hcl) (in vial a- ligand)) - injection, powder, for solution - 0.9 mg/vial - bicisate dihydrochloride (ecd.2hcl) (in vial a- ligand)) 0.9 mg/vial

Australien - engelska - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 59690 - neuromuscular transmission electrode/sensor lead - this device is intended to be non-sterile insulated metal wire(s) designed to conduct electrical signals between neuromuscular transmission (nmt) electrodes and sensors placed on a patient's body and a patient monitoring system module, intended for the monitoring of patient relaxation to determine the level of neuromuscular block and the localization of a nerve in an area of the body. this is a reusable device.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 59693 - neuromuscular transmission electrical skin sensor - this is intended to be a non-sterile device intended to detect electrical neuromuscular transmission (nmt) signals, from an array of neuromuscular electrodes attached to the surface of the skin of the hand and forearm, or the foot, that are subsequently conducted through an nmt sensor cable to a patient monitoring module to assess the degree of neuromuscular block in a patient. it is typically used for applications when the hand alone cannot be used as the measurement site. this is a reusable device.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 59691 - neuromuscular transmission regional anaesthesia block adaptor - this is a non-sterile device intended to conduct electrical signals between itself and an injection needle on a patient?s body, via a neuromuscular transmission (nmt) sensor cable, and subsequently to a patient monitoring module for the localization of a nerve in an area of the body for the administration of regional anaesthesia. this is a reusable device.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 59689 - neuromuscular transmission electrode - this device is intended to be a non-sterile electrical conductor designed to be applied to a patient's body surface, typically the forearm or ankle, to deliver stimulating electrical pulses to a motor nerve or measure electrical impulses from the nerve during neuromuscular transmission (nmt) monitoring. it is typically a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled) intended to be used for neuromuscular block monitoring and nerve stimulation for brachial plexus anaesthesia. this is a single-use device.