États-Unis - anglais - NLM (National Library of Medicine)

rising pharma holdings, inc. - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. teratogenic effects pregnancy category c there are no studies of darifenacin in pregnant women. darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the auc. dystocia was observed in dams at approximately 17 times the auc (10 mg/kg/day). slight developmental delays were observed i

Canada - anglais - Health Canada

searchlight pharma inc - darifenacin (darifenacin hydrobromide) - tablet (extended-release) - 7.5mg - darifenacin (darifenacin hydrobromide) 7.5mg - antimuscarinics

Canada - anglais - Health Canada

searchlight pharma inc - darifenacin (darifenacin hydrobromide) - tablet (extended-release) - 15mg - darifenacin (darifenacin hydrobromide) 15mg - antimuscarinics

Australie - anglais - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - darifenacin hydrobromide, quantity: 17.857 mg (equivalent: darifenacin, qty 15 mg) - tablet, modified release - excipient ingredients: hypromellose; magnesium stearate; calcium hydrogen phosphate; titanium dioxide; purified talc; macrogol 4000; iron oxide yellow; iron oxide red - enablex prolonged-release tablets are indicated for the treatment of overactive bladder, with the symptoms of urgency, urge urinary incontinence or frequency of micturition.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - darifenacin hydrobromide, quantity: 8.929 mg (equivalent: darifenacin, qty 7.5 mg) - tablet, modified release - excipient ingredients: magnesium stearate; hypromellose; calcium hydrogen phosphate; titanium dioxide; purified talc; macrogol 4000 - enablex prolonged-release tablets are indicated for the treatment of overactive bladder, with the symptoms of urgency, urge urinary incontinence or frequency of micturition.

États-Unis - anglais - NLM (National Library of Medicine)

allergan, inc. - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - enablex (darifenacin) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. enablex is contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. pregnancy category c there are no studies of darifenacin in pregnant women. darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the auc. dystocia was observed in dams at approximately 17 times the auc (10 mg/kg/day). slight developmental delays were observed in pups at this dose. at five times the auc (3 mg/kg/day), there were no effect

Union européenne - anglais - EMA (European Medicines Agency)

pharmaand gmbh - darifenacin hydrobromide - urinary incontinence, urge; urinary bladder, overactive - urologicals, drugs for urinary frequency and incontinence - symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

j m mcgill ltd - darifenacin hydrobromide - modified-release tablet - 15mg

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

incepta pharmaceuticals ltd. - darifenacin - pr tablet - 15 mg

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

merus labs luxco s.a r.l. - darifenacin hydrobromide - modified-release tablet - 7.5mg