European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - pegaspargase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents, - oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years, and adult patients.,

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

servier pharmaceuticals llc - pegaspargase (unii: 7d96ir0ppm) (pegaspargase - unii:7d96ir0ppm) - oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with all. oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with all and hypersensitivity to native forms of l-asparaginase. oncaspar is contraindicated in patients with a: - history of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients [see warnings and precautions (5.1)] . - history of serious thrombosis with prior l-asparaginase therapy [see warnings and precautions (5.2)] . - history of pancreatitis, including pancreatitis related to prior l-asparaginase therapy [see warnings and precautions (5.3)] . - history of serious hemorrhagic events with prior l-asparaginase therapy [see warnings and precautions (5.5)] . - severe hepatic impairment [see warnings and precautions (5.6)] . risk summary based on published literature studies with l-asparaginase in pregnant animals, oncaspar can cause fetal harm when administered to a pregnant woman. there are no available data on oncaspar use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. published literature studies in pregnant animals 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 risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. data animal data animal reproduction studies have not been conducted with oncaspar to evaluate its effect on reproduction and fetal development. published literature studies in which pregnant rabbits were administered l-asparaginase or pregnant rats were deprived of dietary asparagine suggested harm to the animal offspring. risk summary there are no data on the presence of pegaspargase 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 oncaspar and for 1 month after the last dose. oncaspar can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy pregnancy testing is recommended in females of reproductive potential prior to initiating oncaspar. contraception advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with oncaspar and for 3 months after the last dose. the safety and effectiveness of oncaspar in the treatment of all have been established in pediatric patients. use of oncaspar in these age groups is supported by evidence of efficacy as first-line treatment from one adequate and well-controlled trial, and evidence of efficacy for treatment of patients with hypersensitivity to asparaginase from four adequate and well-controlled trials [see clinical studies (14.1)] , and safety data from 7 total trials. the pediatric patients treated with oncaspar 2,500 international units/m2 on these trials included 26 infants (1 month to <2 years old), 165 children (2 years to <12 years old), and 39 adolescents (12 to 17 years old). clinical studies of oncaspar did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects.

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

novartis pharmaceuticals australia pty ltd - onasemnogene abeparvovec, quantity: 1 u - injection, intravenous infusion - excipient ingredients: magnesium chloride hexahydrate; water for injections; sodium chloride; poloxamer; hydrochloric acid; trometamol - zolgensma (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (smn1) gene and 1 to 3 copies of the smn2 gene.

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

novartis pharmaceuticals australia pty ltd - onasemnogene abeparvovec, quantity: 1 u - injection, intravenous infusion - excipient ingredients: sodium chloride; water for injections; hydrochloric acid; trometamol; magnesium chloride hexahydrate; poloxamer - zolgensma (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (smn1) gene and 1 to 3 copies of the smn2 gene.

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

novartis pharmaceuticals australia pty ltd - onasemnogene abeparvovec, quantity: 1 u - injection, intravenous infusion - excipient ingredients: sodium chloride; poloxamer; magnesium chloride hexahydrate; water for injections; hydrochloric acid; trometamol - zolgensma (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (smn1) gene and 1 to 3 copies of the smn2 gene.

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

tesaro, inc. - niraparib (unii: hmc2h89n35) (niraparib - unii:hmc2h89n35) - niraparib 100 mg - zejula® is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. zejula® is indicated for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either: - a deleterious or suspected deleterious brca mutation, or - genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy [see clinical studies (14.2)] . select patients for therapy based on an fda-approved companion diagnostic for zejula. none. risk summary based on its mechanism of action, zejula can cause fetal harm when administered to pregnant women [see clinical pharmacology (12.1)] . there are no data regarding the use

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

glaxosmithkline australia pty ltd - niraparib tosilate monohydrate, quantity: 159.4 mg (equivalent: niraparib, qty 100 mg) - capsule, hard - excipient ingredients: lactose monohydrate; gelatin; magnesium stearate; titanium dioxide; erythrosine; tartrazine; brilliant blue fcf; propylene glycol; ethanol; isopropyl alcohol; shellac; povidone; tert-butyl alcohol; sodium hydroxide; butan-1-ol; purified water; ethanol absolute; iron oxide black; ammonia; potassium hydroxide - for the maintenance treatment of adult patients with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.,as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

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

de pharmaceuticals - metoclopramide hydrochloride; paracetamol - oral tablet - 5mg ; 500mg

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

servier laboratories (aust) pty ltd - pegaspargase, quantity: 750 u/ml - solution, powder for - excipient ingredients: sucrose; dibasic sodium phosphate; monobasic sodium phosphate; sodium chloride; sodium hydroxide; hydrochloric acid - oncaspar is indicated as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia (all).

Kenya - English - Pharmacy and Poisons Board

beacon medicare limited 9/b/2, toyenbee circular road, motijheel, - niraparib tosylate monohydrate - capsule - niraparib 100mg - niraparib