United States - English - NLM (National Library of Medicine)

physicians total care, inc. - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - evista is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] . evista is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . evista is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)] . the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)] . twenty-seven percent of the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not known. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-

United States - English - NLM (National Library of Medicine)

eli lilly and company - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - evista is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] . evista is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . evista is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)] . the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)] . twenty-seven percent of the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not known. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-y

Israel - English - Ministry of Health

eli lilly israel ltd, israel - raloxifene hydrochloride - film coated tablets - raloxifene hydrochloride 60 mg - raloxifene - raloxifene - evista is indicated for the treatment of osteoporosis in post menopausal women. evista is indicated for the prevention of osteoporosis in post menopausal women . evista is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. evista is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.

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

eli lilly australia pty ltd - raloxifene hydrochloride, quantity: 60 mg - tablet, film coated - excipient ingredients: crospovidone; polysorbate 80; magnesium stearate; lactose monohydrate; lactose; povidone; carnauba wax; colour; propylene glycol; indigo carmine; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; industrial methylated spirit; ethanol - evista is indicated for the prevention and treatment of osteoporosis in post-menopausal women. evista is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis. evista is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer >1.66% (based on the modified gail model). among the factors included in the modified gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.

European Union - English - EMA (European Medicines Agency)

substipharm - raloxifene hydrochloride - osteoporosis, postmenopausal - sex hormones and modulators of the genital system, - evista is indicated for the treatment and prevention of osteoporosis in post-menopausal women. a significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. when determining the choice of evista or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

lilly, s.a. - raloxifeno clorhidrato - raloxifeno clorhidrato....60.00 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

eli lilly and company (nz) limited - raloxifene hydrochloride 60mg equivalent to 55.7 mg raloxifene free base - film coated tablet - 60 mg - active: raloxifene hydrochloride 60mg equivalent to 55.7 mg raloxifene free base excipient: carnauba wax crospovidone lactose lactose monohydrate magnesium stearate opacode blue s-1-10537g opadry white ys-1-18027-a polysorbate 80 povidone

Singapore - English - HSA (Health Sciences Authority)

lotus international pte. ltd. - raloxifene hcl - tablet, film coated - 60 mg - raloxifene hcl 60 mg

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

raloxifene hydrochloride -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

lotus pharmaceutical co ltd - raloxifene hydrochloride -