Malta - angļu - Medicines Authority

ferring pharmaceuticals limited drayton hall, church road, west drayton ub7 7ps, united kingdom - misoprostol - vaginal delivery system - misoprostol 200 µg - other gynecologicals

Lielbritānija - angļu - MHRA (Medicines & Healthcare Products Regulatory Agency)

ferring pharmaceuticals ltd - misoprostol - vaginal delivery system - 7microgram/1hour

Beļģija - angļu - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

purna pharmaceuticals - zinc oxide - ointment - zinc oxide 250 mg/g - zinc products

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - rivastigmine, quantity: 27 mg - drug delivery system, transdermal - excipient ingredients: acrylates copolymer; dl-alpha-tocopherol; dimeticone 12500; ethyl acetate; methylated trimethylated silica; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - exelon / prometax is indicated for the treatment of patients with mild, moderate and severe dementia of the alzheimer's type.

Austrālija - angļu - 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.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 0.77 mg (equivalent: estradiol, qty 0.75 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). estraderm mx 25 is not indicated for the prevention of post-menopausal bone mineral density loss. 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

Austrālija - angļu - 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.

Eiropas Savienība - angļu - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - umeclidinium bromide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).,

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

care pharmaceuticals pty ltd - zinc oxide -

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - lanadelumab, quantity: 300 mg - injection, solution - excipient ingredients: citric acid monohydrate; water for injections; dibasic sodium phosphate dihydrate; polysorbate 80; histidine; sodium chloride - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (c1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years and older.