Canada - English - Health Canada

merck canada inc - hepatitis b surface antigen (recombinant) - solution - 40mcg - hepatitis b surface antigen (recombinant) 40mcg - vaccines

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

viiv healthcare uk ltd - lamivudine; zidovudine - tablet - 150mg ; 300mg

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

carl zeiss pty ltd - 36108 - aqueous/vitreous humour replacement medium kit - the performance of combivisc? cohesive and dispersive are due to the rheological properties of the sodium hyaluronate solutions (1.5 and 3.0% respectively). they are clear viscoelastic solutions at rest, yet under pressure they are easily passed through a fine cannula. the cohesive solution creates space and maintains a deep anterior chamber. the dispersive solution offers corneal endothelial cell protection due to increased retention during phacoemulsification. combivisc? consists of two ophthalmic viscosurgical devices (dispersive and cohesive) that can be used jointly or independently in surgical interventions to remove cataract and implant a prosthetic lens. combivisc? dispersive coats the corneal endothelium providing a protective barrier during phacoemulsification, maintains the space in the anterior chamber and can be used to lubricate the surgical instruments used during the procedure. combivisc? cohesive creates and maintains a deep chamber and space in which to work within the anterior chamber of the eye, thus minimising the risk of mechanical damage to any of the ocular structures.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - recombinant human deoxyribonuclease - solution for inhalation - recombinant human deoxyribonuclease 1 mg/ml - dornase alfa (desoxyribonuclease) - dornase alfa (desoxyribonuclease) - management of cystic fibrosis not for patients under 5 years of age or with fvc<40% .

European Union - English - EMA (European Medicines Agency)

unigene uk ltd. - recombinant salmon calcitonin - hypercalcemia; osteitis deformans; bone resorption - calcium homeostasis - calcitonin is indicated for:prevention of acute bone loss due to sudden immobilisation such as in patients with recentosteoporotic fracturespaget's diseasehypercalcaemia of malignancy

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

philips electronics australia ltd - 45143 - combination diagnostic imaging system, pet/ct - a diagnostic imaging system that combines positron emission tomography (pet) and x-ray computed tomography (ct) systems. the ct subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. the pet subsystem produces images of the distribution of pet radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). ct data is applied to the pet data for attenuation correction. the pet subsystem also provides for list mode, dynamic, and gated acquisitions.

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

philips electronics australia ltd - 45143 - combination diagnostic imaging system, pet/ct - a diagnostic imaging device that combines positron emission tomography (pet) and x-ray computed tomography (ct) systems. the ct subsystem images anatomical cross-sections by computer reconstruction of x-ray transmission data. the pet subsystem images the distribution of pet anatomy-specific radiopharmaceuticals in the patient. the pet/ct system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. the system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic,and other major organs for a wide range of patient types, sizes, and extent of diseases. both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the ct scanner for diagnosis and for use in radiation therapy planning.

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

canon medical systems anz pty ltd - 45143 - combination diagnostic imaging system, pet/ct - a diagnostic imaging system that combines positron emission tomography (pet) and x-ray computed tomography (ct) systems. the ct component produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. the pet component images the distribution of pet radiopharmaceuticals in the patient body.

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

ge healthcare australia pty ltd - 45143 - combination diagnostic imaging system, pet/ct - the omni legend pet/ct system is intended for ct attenuation corrected, anatomically localized pet

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

siemens healthcare pty ltd - 45143 - combination diagnostic imaging system, pet/ct - a radiological imaging system that is a combination of a positron emission tomography camera system for nuclear medicine images, and a computed tomography camera system for x-ray images.