Malta - English - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - celecoxib - hard capsule - celecoxib 200 mg - antiinflammatory and antirheumatic products

Malta - English - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - rivastigmine - transdermal patch - rivastigmine 13.3 mg/24 h - psychoanaleptics

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

elekta pty ltd - 35159 - accelerator system, linear - elekta unity using magnetic resonance imaging, is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a define treatment plan. elekta unity is intended for use with compatible treatment planning and oncology information systems. the elekta unity 1.5t mri scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during and after the radiotherapy treatment. when interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology

Malta - English - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - film-coated tablet - cefuroxime axetil 250 mg - antibacterials for systemic use

Malta - English - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - granules for oral suspension - cefuroxime 250 mg/5ml - antibacterials for systemic use

Malta - English - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - film-coated tablet - cefuroxime 500 mg - antibacterials for systemic use

Malta - English - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - granules for oral suspension - cefuroxime 125 mg/5ml - antibacterials for systemic use

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

elekta pty ltd - 45065 - patient monitoring system, respiratory, radiation procedure - the active breathing coordinator is indicated for use when there is a need to reduce the anatomical movement in the thorax and abdomen caused by breathing and cardiac motion. it is intended for breath-hold (bh) during simulation and delivery of external beam radiation therapy (ebrt) using photons, in single or multiple fractions, administered via static and/or dynamic delivery processes, in any and all areas of the body where such treatment is indicated. it also provides electrical prompts and status information for the elekta limited response? gating interface when automated gating of the linac is used.the active breathing coordinator is specifically indicated for:a. breast tumors, including total and partial breast irradiation techniques, where immobilized anatomy provided by deep inspiration breath-hold (dibh) allows critical organ sparing, such as decreasing radiation dose to heart, lung and other surrounding normal tissue.b. lung cancers and other thoracic tumors (such as esophagus, lymphoma, and metastatic lesions) where immobilized anatomy provided by dibh allows critical organ sparing, including reducing both dose and volume of irradiated normal tissue, and enabling potential reduction of tumor target margins. also included is the use of linac-based stereotactic radiosurgery (srs) and stereotactic radiation therapy (srt) that may be employed to treat such lesions.c. liver tumors, where immobilized anatomy provides critical organ sparing, including reducing both dose and volume of irradiated normal tissue enabling potential reduction of tumor target tissue margins. also included is the use of linac-based srs and srt that may be employed to treat such lesions.d. pancreatic tumors, where immobilized anatomy allows critical organ sparing including reducing both dose and volume of irradiated normal tissue, enabling potential reduction of tumor target tissue margins. also included is the use of linac-based srs and srt that may be employed to treat such lesions

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

elekta pty ltd - 45446 - patient positioning system, ultrasound - clarity? is indicated for use in external beam radiation therapy. it provides 3d ultrasound and hybrid imaging of soft tissue anatomy to aid in radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment (image guided radiation therapy). when configured with an autoscan probe kit for transperineal ultrasound (tpus) imaging, clarity? may be used to continuously track and monitor the motion of the prostate and to accurately and precisely guide patient positioning during the delivery of treatment (intrafractional position tracking and monitoring). when configured with a gating option, clarity? may also interface with radiation delivery systems equipped with a compatible external gating control device. with this option, while in tracking and monitoring mode, clarity? can signal the radiation delivery system to automatically impose a beam-hold when the position of the tracked anatomy has exceeded pre-defined monitoring (tracking) limits, and signal again to release the beam-hold when the tracked anatomy returns to a position within those limits (exception gating). exception gating has been shown to be compatible with radiation delivery systems equipped with elekta?s response? gating control system.

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

novartis corporation (malaysia) sdn. bhd. - entecavir monohydrate -