澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

sigma company limited - 13755 - stethoscope, mechanical - a mechanical listening device used for listening to sounds from the heart and lungs. it typically comprises a membrane at the listening head connected by a split "y" tube to the head gear with ear olives that are placed into the users ears. mechanical stethoscopes are typically found in two variants: 1. a general-purpose stethoscope used for clinical/ward activities. 2. a reinforced stethoscope used by cardiologists.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

med & surgical requisites pty ltd - 13750 - stethoscope, - a mechanical listening device used for listening to sounds from the heart and lungs. comprising of a membrane at the listening head connected by a split "y" tube to the head gear with ear olives that are placed into the users ears. the mechanical stethoscope is suitable for use in clinical/ward activities and a reinforced stethoscope is available for cardiologists use.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 41670 - radiology picture archiving and communication system application software - this device is a web-based 3d visualization software to display, review, annotate and export the cardiac 3d models that is intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians).

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 57812 - radiology dicom image processing application software - us2.v1 is a software platform that automatically processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, producing a full report with measurements of several key cardiac structural and functional parameters. the data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making based on dicom images produced by fda approved ultrasound devices. us2.v1 is indicated for use in adult patients. us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumours, thrombi).

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

loop healthcare pty ltd - 41651 - electrocardiograph, holter analyser, software - rooticare system is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ecg technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ecg and ecg data acquired from rootirx. rooticare includes an algorithm that will analyze single lead ecg and produce measurements of the ecg recording as well as textual interpretation. rooticare system will be accessed over internet and data will be stored at the rooticare data warehouse. data will be secure, and with separate data stores for each client. users will be able to access specific modules for managing patient cardiac related data such as arrhythmia data that fit their patients' needs. rooticare is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. rooticare does not offer diagnosis or medical alarms. it is intended that competent human intervention be involved before any impact on health occurs. clinical judgment and experience are used to check and interpret the data.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

branded products pty ltd - 13755 - stethoscope, mechanical - a mechanical listening device designed for listening to sounds from the heart, lungs, and/or gastrointestinal tract. it typically comprises a membrane at the listening head connected by a split "y" tube to the headgear with ear olives that are placed into the users ears. mechanical stethoscopes are typically found in two variants 1) a general-purpose stethoscope used for clinical/ward activities; or 2) a reinforced stethoscope used by cardiologists.

马耳他 - 英文 - Medicines Authority

merz pharmaceuticals gmbh eckenheimer landstrasse 100, d-60318 frankfurt am main, germany - amantadine sulfate - solution for infusion - amantadine sulfate 0.4 mg/ml - anti-parkinson drugs

亚美尼亚 - 英文 - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ebewe pharma ges. m.b.h. nfg. kg - doxorubicin (doxorubicin hydrochloride) - concentrate for solution for infusion - 2mg/ml

亚美尼亚 - 英文 - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ebewe pharma ges. m.b.h. nfg. kg - doxorubicin (doxorubicin hydrochloride) - concentrate for solution for infusion - 2mg/ml

以色列 - 英文 - Ministry of Health

roche pharmaceuticals (israel) ltd - trastuzumab - solution for infusion - trastuzumab 440 mg/ml - trastuzumab - trastuzumab - herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: 1. as a single agent for the treatment of those patients who have received one or more chemotherapy regiments for their metastatic disease. 2. in combination with paclitaxel or docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 3. herceptin in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer. early breast cancer (ebc) :herceptin is indicated to treat patients with her2-positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding anthracyclines. herceptin should only be used in patients whose tumors have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.her2 metastatic gastric cancer (mgc)herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.herceptin should only be used in patients with metastatic gastric cancer whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory fish+ result, or ihc 3+, as determined by an accurate and validated assay