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

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 3.09 mg (equivalent: estradiol, qty 3 mg) - drug delivery system, transdermal - excipient ingredients: isopropyl palmitate; polyethylene terephthalate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - menopausal symptoms: short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. in women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (refer to section 5.1 pharmacodynamic properties - clinical trials and section 4.2 dose and method of administration). prevention of post-menopausal bone mineral density loss: estraderm mx 50, 75 and 100 may be used for prevention of post-menopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of bone mineral density loss. lifestyle modifications and the risk-benefit profile of estraderm mx should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing( see section 4.4 special warnings and precautions for use and section 4.2 dose and method of administration). combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer.

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

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 1.54 mg (equivalent: estradiol, qty 1.5 mg) - drug delivery system, transdermal - excipient ingredients: isopropyl palmitate; polyethylene terephthalate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - menopausal symptoms: short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. in women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (refer to section 5.1 pharmacodynamic properties - clinical trials and section 4.2 dose and method of administration). prevention of post-menopausal bone mineral density loss: estraderm mx 50, 75 and 100 may be used for prevention of post-menopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of bone mineral density loss. lifestyle modifications and the risk-benefit profile of estraderm mx should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing (see section 4.4 special warnings and precautions for use and sectoin 4.2 dose and method of administration). combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - pirfenidone - hard capsule - pirfenidone 267 mg - pirfenidone - esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).27/01/2019 בקשה לתוספת התויה renal impairment no dose adjustment is necessary in patients with mild to moderate renal impairment. esbriet should be used with caution in patients with moderate (crcl 30-50 ml/min) renal impairment.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - pirfenidone - hard capsule - pirfenidone 267 mg - pirfenidone - esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).27/01/2019 בקשה לתוספת התויה renal impairment no dose adjustment is necessary in patients with mild to moderate renal impairment. esbriet should be used with caution in patients with moderate (crcl 30-50 ml/min) renal impairment.

Malta - English - Medicines Authority

institute of isotopes co. ltd h-1121 budapest, konkoly-thege miklós út 29-33, hungary - tetrakis, methoxy isobutyl, isonitrile, copper, tetrafluorolborate - kit for radiopharmaceutical preparation powder for solution for injection - tetrakis (2-methoxy isobutyl isonitrile) copper (i) tetrafluorolborate 1 mg - diagnostic radiopharmaceuticals

Malta - English - Medicines Authority

medi-radiopharma ltd 2030 erd szamos st. 10-12, hungary - kit for radiopharmaceutical preparation - macroaggregated human albumin 2.5 mg - diagnostic radiopharmaceuticals

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

doseme pty ltd - 58842 - pharmaceutical information system application software - doseme is a software application program, containing bayesian dosing algorithms, intended for drug dosage decision support and use as an information system to store, manage and assist in the analysis of patient data within healthcare facilities. doseme assists with the dose management of therapeutic pharmaceuticals. the system has functionality to aid in dosing, in particular allowing for dosing adjustment when required by drug interactions. the device is available as an app for use on portable smart devices and for use via a web interface on many types of computers and networks.

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

ferring pharmaceuticals pty ltd -

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

aft pharmaceuticals pty ltd - granisetron hydrochloride -

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

aft pharmaceuticals pty ltd - granisetron hydrochloride -