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

vital diagnostics pty ltd -

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).

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

alvogen inc. - amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e), dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - amphetamine aspartate monohydrate 1.25 mg - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. attention deficit hyperactivity disorder (adhd) a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental eff

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

the royal children's hospital - monosodium aspartate, quantity: 1.4 mmol/ml - injection, concentrated - excipient ingredients: water for injections - substrate for organ perfusion.

New Zealand - English - Medsafe (Medicines Safety Authority)

servier laboratories nz ltd - pegaspargase 3750 u (4050u including overage) - powder for injection - 3750 u/5ml - active: pegaspargase 3750 u (4050u including overage) excipient: dibasic sodium phosphate hydrochloric acid monobasic sodium phosphate sodium chloride sodium hydroxide sucrose - oncaspar is indicated as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia (all).

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

astellas pharma us, inc. - gilteritinib fumarate (unii: 5rzz0z1gjt) (gilteritinib - unii:66d92mgc8m) - xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (aml) with a fms-like tyrosine kinase 3 (flt3) mutation as detected by an fda-approved test. xospata is contraindicated in patients with hypersensitivity to gilteritinib or any of the excipients. anaphylactic reactions have been observed in clinical trials [see adverse reactions (6) and description (11)] . risk summary based on findings from animal studies (see data) and its mechanism of action, xospata can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on xospata use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, administration of gilteritinib to pregnant rats during organogenesis caused adverse developmental outcomes including embryo-fetal lethality, suppressed fetal growth, and teratogenicity at maternal exposures (auc24 ) approximately 0.4 times the auc

Israel - English - Ministry of Health

astellas pharma international b.v., israel - gilteritinib as fumarate - film coated tablets - gilteritinib as fumarate 40 mg - gilteritinib - xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (aml) with a flt3 mutation

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

astellas pharma australia pty ltd - gilteritinib fumarate, quantity: 44.2 mg - tablet, film coated - excipient ingredients: hyprolose; magnesium stearate; mannitol; titanium dioxide; macrogol 8000; hypromellose; purified talc; iron oxide yellow - xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (aml) with a flt3 mutation.

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.,

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

servier laboratories australia pty ltd - pegaspargase -