Israel - English - Ministry of Health

truemed ltd. - estradiol as hemihydrate - patches - estradiol as hemihydrate 3.2 mg - estradiol - deficiency symptoms by absence of estrogen after the menopause or after surgical removal of the ovarians. they comprise hot flushes, insomnia, atrophies of the urogenital system, changes of mood and increasing loss of the bone substance, which can lead to osteoporosis. in women with intact uterus, estrogen substitution must always be supplemented with a sequential gestagen therapy.

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

servier pharmaceuticals llc - calaspargase pegol (unii: t9fvh03hmz) (calaspargase pegol - unii:t9fvh03hmz) - asparlas is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. asparlas is contraindicated in patients with: - history of serious hypersensitivity reactions, including anaphylaxis, to pegylated l-asparaginase therapy [see warnings and precautions (5.1)] - history of serious pancreatitis during previous l-asparaginase therapy [see warnings and precautions (5.2)] - history of serious thrombosis during previous l-asparaginase therapy [see warnings and precautions (5.3)] - history of serious hemorrhagic events during previous l-asparaginase therapy [see warnings and precautions (5.4)] - severe hepatic impairment [see warnings and precautions (5.5)] risk summary based on published literature studies with l-asparaginase in pregnant animals, asparlas can cause fetal harm when administered to a pregnant woman. there are no available data on asparlas use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, intravenous administration of calaspargase pegol-mknl to pregnant rats during organogenesis at doses 0.2 to 1 times the maximum recommended human doses did not result in adverse developmental outcomes. published literature studies in pregnant rabbits, however, suggest asparagine depletion may cause harm to the animal offspring (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. data animal data in an embryo-fetal development study, calaspargase pegol-mknl was administered intravenously at doses of 75, 150, and 300 u/kg (0.2, 0.6 and 1 times the maximum recommended human dose, respectively, based on auc) to pregnant rats during the period of organogenesis. maternal toxicity of decreased body weight and food consumption was seen at all dose levels resulting in reductions in gravid uterine and placental weights, and slight reductions in fetal body weights. no evidence of structural abnormalities or embryo-fetal mortality were observed in this study at any of the doses tested. published literature studies in which pregnant rabbits were administered l-asparaginase suggested harm to the animal offspring. risk summary there are no data on the presence of calaspargase pegol-mknl in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with asparlas and for 3 months after the last dose. asparlas can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing pregnancy testing is recommended in females of reproductive potential prior to initiating asparlas. contraception advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with asparlas and for at least 3 months after the last dose. the safety and effectiveness of asparlas in the treatment of all have been established in pediatric patients 1 month to <17 years (no data for the age group <1 month old). use of asparlas in these age groups is supported by evidence from an adequate and well-controlled trial with additional safety from a second trial. the trials included 208 children with all or lymphoblastic lymphoma treated with asparlas; there were 19 infants (1 month to <2 years old), 128 children (2 years to <12 years old), and 61 adolescents (12 years to <17 years old). there were no clinically meaningful differences in safety or nadir serum asparaginase activity across age groups [see adverse reactions (6.1), clinical studies (14)] .

Israel - English - Ministry of Health

neopharm ltd, israel - certolizumab pegol - solution for injection - certolizumab pegol 200 mg/ml - certolizumab pegol - rheumatoid arthritis:cimzia, in combination with methotrexate (mtx), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis (ra) in adult patients when the response to disease-modifying antirheumatic drugs (dmards) including methotrexate, has been inadequate. cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.axial spondyloarthritis:cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: ankylosing spondylitis (as): adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). axial spondyloarthritis without radiographic evidence of as adults with severe active axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated c reactive protein (crp) and /or magnetic resonance imaging (mri), who have had an inadequate response to, or are intolerant to nsaids. crohn's disease :cimzia is indicated for reducing signs and symptoms of crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.plaque psoriasis:cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who arecandidates for systemic therapy.

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

iveric bio, inc. - avacincaptad pegol sodium (unii: k86enl12i5) (avacincaptad pegol - unii:tt0v5jlg5b) - izervay™ is indicated for the treatment of geographic atrophy (ga) secondary to age-related macular degeneration (amd). izervay is contraindicated in patients with ocular or periocular infections. izervay is contraindicated in patients with active intraocular inflammation. risk summary there are no adequate and well-controlled studies of izervay administration in pregnant women. the use of izervay may be considered following an assessment of the risks and benefits. administration of avacincaptad pegol to pregnant rats and rabbits throughout the period of organogenesis resulted in no evidence of adverse effects to the fetus or pregnant female at intravenous (iv) doses 5.1 times and 3.2 times the human exposure (based on auc) at the maximum recommended human dose (mrhd) of 2 mg once monthly, respectively (see data) . in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15%-20%, respectively. data animal data an embryo fetal developmental toxicity study was conducted with pregnant rats. pregnant rats received daily intravenous (iv) injections of avacincaptad pegol from day 6 to day 17 of gestation at 0.1, 0.4, 1.2 mg/kg/day. no maternal or embryofetal adverse effects were observed at any dose evaluated. an increase in the incidence of a non-adverse skeletal variation, described as short thoracolumbar (ossification site without distal cartilage) supernumerary ribs, was observed at all doses evaluated. the clinical relevance of this finding is unknown. plasma exposures at the high dose were 5.1 times the mrhd, based on area under the curve (auc). an embryo fetal developmental toxicity study was conducted with pregnant rabbits. pregnant rabbits received daily iv injections of avacincaptad pegol from day 7 to day 19 of gestation at 0.12, 0.4, 1.2 mg/kg/day. no maternal or embryofetal adverse effects were observed at any dose evaluated. plasma exposure in pregnant rabbits at the highest dose of 1.2 mg/kg/day was 3.2 times the human exposure at the mrhd, based on auc. risk summary there is no information regarding the presence of avacincaptad pegol in human milk, the effects of the drug on the breastfed infant, or the effects of avacincaptad pegol on milk production. many drugs are transferred in human milk with the potential for absorption and adverse reactions in the breastfed child. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for izervay, and any potential adverse effects on the breastfed infant from izervay. safety and effectiveness of izervay in pediatric patients have not been established. of the total number of patients who received izervay in the two clinical trials, 90% (263/292) were ≥65 years and 61% (178/292) were ≥75 years of age. no significant differences in efficacy or safety of avacincaptad pegol were seen with increasing age in these studies. no dose adjustment is required in patients 65 years and above.

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

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

theramex hq uk ltd - norethisterone acetate; estradiol - transdermal patch - 170microgram/24hour ; 50microgram/24hour

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

mansa healthcare sdn bhd - temozolomide -