Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp & dohme ireland (human health) limited - tibolone - tablet - 2.5 milligram(s) - other estrogens; tibolone

Ireland - English - HPRA (Health Products Regulatory Authority)

organon pharma (ireland) limited - tibolone - tablet - 2.5 milligram(s) - other estrogens; tibolone

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

southern cross pharma pty ltd - tibolone, quantity: 2.5 mg - tablet, uncoated - excipient ingredients: magnesium stearate; mannitol; lactose monohydrate; potato starch; ascorbyl palmitate - - short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women.,- second line therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pi pharma - tibolone - tablet - 2,5 mg - tibolone 2.5 mg - tibolone

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pi pharma - tibolone - tablet - 2,5 mg - tibolone 2.5 mg - tibolone

Ireland - English - HPRA (Health Products Regulatory Authority)

ltt pharma limited - tibolone - tablet - 2.5 milligram(s) - other estrogens; tibolone

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - tibolone - tablet - 2.5 milligram(s) - other estrogens; tibolone

Ireland - English - HPRA (Health Products Regulatory Authority)

imbat limited - tibolone - tablet - 2.5 milligram(s) - other estrogens; tibolone

Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - tibolone - tablet - 2.5 milligram(s) - other estrogens; tibolone

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

arrotex pharmaceuticals pty ltd - tibolone, quantity: 2.5 mg - tablet, uncoated - excipient ingredients: pregelatinised potato starch; ascorbyl palmitate; magnesium stearate; lactose monohydrate; lactose - ? short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women. ? second line therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. after careful selection of users, <> (tibolone tablets) should be prescribed for the shortest duration consistent with treatment goals. review the need for continuation of treatment after 6 months, taking into account the risk-benefit ratio for the individual user at that moment (including cardiovascular disease and breast cancer, see clinical trials and precautions). <> (tibolone tablets) should only be continued for as long as the benefit outweighs the risks.