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

pahang pharmacy sdn. bhd. - losartan potassium; hydrochlorothiazide -

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

arrotex pharmaceuticals pty ltd - raloxifene hydrochloride, quantity: 60 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; crospovidone; polysorbate 80; povidone; microcrystalline cellulose; magnesium stearate; glycine; titanium dioxide; hypromellose; carnauba wax; macrogol 400 - raloxifene is indicated for the prevention and treatment of osteoporosis in post-menopausal women.,raloxifene is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis.raloxifene is indicated for the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

janssen biotech, inc. - teclistamab (unii: 54534mx6z9) (teclistamab - unii:54534mx6z9) - tecvayli is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody. this indication is approved under accelerated approval based on response rate [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary based on the mechanism of action, tecvayli may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of tecvayli in pregnant women to evaluate for a drug associated risk. no animal reproductive or developmental toxicity studies have been conducted with tecvayli. teclistamab-cqyv causes t-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. human immunoglobulin g (igg) is known to cross the placenta; therefore, teclistamab-cqyv has the potential to be transmitted from the mother to the developing fetus. advise women of the potential risk to the fetus. tecvayli is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with tecvayli should be considered. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there are no data on the presence of teclistamab-cqyv in human milk, the effect on the breastfed child, or the effects on milk production. maternal igg is known to be present in human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to tecvayli are unknown. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with tecvayli and for 5 months after the last dose. tecvayli may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating tecvayli. contraception females advise females of reproductive potential to use effective contraception during treatment and for 5 months after the last dose of tecvayli. the safety and efficacy of tecvayli have not been established in pediatric patients. of the 165 patients with relapsed or refractory multiple myeloma treated with tecvayli in majestec-1 at the recommended dosage, 48% were 65 years of age or older, and 15% were 75 years of age or older. no overall differences in safety or effectiveness were observed between patients 65 to 74 years of age compared to younger patients. there is an insufficient number of patients 75 years of age or older to assess whether there are differences in safety or effectiveness.

Bangladesh - Inggeris - DGDA (Directorate General of Drug Administration)

square formulations ltd. - orlistat - capsule - 120 mg

Bangladesh - Inggeris - DGDA (Directorate General of Drug Administration)

square formulations ltd. - orlistat - capsule - 60 mg

Bangladesh - Inggeris - DGDA (Directorate General of Drug Administration)

square pharmaceuticals plc, gazipur - orlistat - capsule - 120 mg

Bangladesh - Inggeris - DGDA (Directorate General of Drug Administration)

square pharmaceuticals plc, gazipur - orlistat - capsule - 60 mg

Malta - Inggeris - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - orlistat - hard capsule - orlistat 60 mg - antiobesity preparations, excl. diet products

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

pharmaco australia ltd - orlistat, quantity: 120 mg - capsule, hard - excipient ingredients: lecithin; gelatin; sodium lauryl sulfate; dimeticone 1510; indigo carmine; sodium starch glycollate; iron oxide black; titanium dioxide; microcrystalline cellulose; shellac; purified talc; povidone - xenical is indicated for the treatment of obese patients with a body mass index (bmi) >= 30, and overweight patients with a bmi >= 27 in the presence of other risk factors, in conjunction with a mildly hypocaloric diet.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

haleon us holdings llc - orlistat (unii: 95m8r751w8) (orlistat - unii:95m8r751w8) - orlistat 60 mg - weight loss aid - for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet