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

alphapharm pty ltd - selegiline hydrochloride -

Canada - English - Health Canada

teva canada limited - selegiline hydrochloride - tablet - 5mg - selegiline hydrochloride 5mg - monoamine oxidase b inhibitors

Canada - English - Health Canada

mylan pharmaceuticals ulc - selegiline hydrochloride - tablet - 5mg - selegiline hydrochloride 5mg - monoamine oxidase b inhibitors

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

mylan specialty l.p. - selegiline (unii: 2k1v7gp655) (selegiline - unii:2k1v7gp655) - selegiline 6 mg in 24 h - emsam (selegiline transdermal system) is a monoamine oxidase inhibitor (maoi) indicated for the treatment of adults with major depressive disorder (mdd) [see clinical studies (14)] . the available data on emsam use in pregnant women are not sufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. in animal embryo-fetal development studies, transdermal administration of selegiline to rats and rabbits at doses up to 60 and 64 times the maximum recommended human dose (mrhd) respectively, produced slight increases in malformations in both rats and rabbits, and decreased fetal weight, delayed ossification, and embryo-fetal post-implantation loss in rats. most of these effects were seen at the high dose in both rats and rabbits. these effects were not seen at 8 times and 16 times the mrhd in rats and rabbits, respectively. in a pre-natal and post-natal development study, transdermal administration of selegiline in rats at doses 8, 24, and 60 times mrhd produced a decrease in pup weight an

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

bausch health us, llc - selegiline hydrochloride (unii: 6w731x367q) (selegiline - unii:2k1v7gp655) - selegiline hydrochloride 1.25 mg - zelapar is indicated as an adjunct in the management of patients with parkinson’s disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. there is no evidence from controlled studies that zelapar has any beneficial effect in the absence of concurrent levodopa therapy [see clinical studies (14) ]. zelapar is contraindicated in patients with: risk summary there are no adequate data on the developmental risk associated with the use of zelapar in pregnant women. in animal studies, administration of selegiline during pregnancy was associated with developmental toxicity (decreased embryofetal and postnatal offspring growth and survival) at doses greater than those used clinically. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage in the indicated population is u

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

teva takeda pharma ltd. - selegiline hydrochloride - white tablet, diameter: 6.5 mm, thickness: 2.7 mm

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

teva pharma australia pty ltd - modafinil, quantity: 100 mg - tablet - excipient ingredients: lactose monohydrate; pregelatinised maize starch; croscarmellose sodium; povidone; magnesium stearate; microcrystalline cellulose - modavigil is indicated: to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy; to treat excessive sleepiness associate with moderate to severe chronic shift work sleep disorder where nonpharmacological interventions are unsuccessful or inappropriate; as an adjunct to continuous positive airways pressure (cpap) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness.

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - selegiline hydrochloride 5mg;  ;  ;   - tablet - 5 mg - active: selegiline hydrochloride 5mg       excipient: lactose monohydrate magnesium stearate microcrystalline cellulose starch

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.