Ireland - English - HPRA (Health Products Regulatory Authority)

aristo pharma gmbh - tibolone - tablet - 2.5 milligram(s) - other estrogens; tibolone

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

aristo pharma gmbh - tibolone 2,5 mg - tablet - 2,5 mg - tibolone 2.5 mg - tibolone

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

aristo pharma ltd - tibolone - oral tablet - 2.5mg

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.

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

strides pharma ltd. - tibolone 2,5 mg - tablet - 2,5 mg - tibolone 2.5 mg - tibolone

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

gedeon richter plc - tibolone 2,5 mg - tablet - 2,5 mg - tibolone 2.5 mg - tibolone

Israel - English - Ministry of Health

organon pharma israel ltd., israel - tibolone - tablets - tibolone 2.5 mg - tibolone - tibolone - • complaints resulting from the natural or artificial menopause.treatment of oestrogen deficiency symptoms in postmenopausal women, more than one year after menopause. women above 60 years of age should only start with livial treatment when they are intolerant of, or contraindicated for, other medicinal products approved for the treatment of oestrogen deficiency symptoms.• prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.for all women the decision to prescribe tibolone livial should be based on an assessment of the individual patient’s overall risks and, particularly in the over 60s, should include consideration of the risk of stroke.

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

southern cross pharma pty ltd - tibolone, quantity: 2.5 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; potato starch; ascorbyl palmitate; magnesium stearate; mannitol - - 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.

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

advanz pharma - tibolone - oral tablet - 2.5mg

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

actor pharmaceuticals pty ltd - tibolone, quantity: 2.5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; ascorbyl palmitate; magnesium stearate; potato starch - indications ? 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, tibogen 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 the moment (including cardiovascular disease and breast cancer, refer clinical trials and precautions). tibogen should only be continued for as long as the benefit outweighs the risks.