Ireland - English - HPRA (Health Products Regulatory Authority)

recordati ireland limited - alprostadil - cream - 3 milligram(s)/gram - drugs used in erectile dysfunction; alprostadil - : drugs used in erectile dysfunction - treatment of men
18 years of age with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance

European Union - English - EMA (European Medicines Agency)

recordati ireland ltd. - lidocaine, prilocaine - sexual dysfunction, physiological - anesthetics - treatment of primary premature ejaculation in adult men.

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

recordati rare diseases, inc. - ethotoin (unii: 46qg38nc4u) (ethotoin - unii:46qg38nc4u) - ethotoin 250 mg - peganone (ethotoin tablets, usp) is indicated for the control of tonic-clonic (grand mal) and complex partial (psychomotor) seizures. peganone (ethotoin tablets, usp) is contraindicated in patients with hepatic abnormalities or hematologic disorders.

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

recordati rare diseases, inc. - methamphetamine hydrochloride (unii: 997f43z9cv) (methamphetamine - unii:44ral3456c) - methamphetamine hydrochloride 5 mg - attention deficit disorder with hyperactivity: desoxyn tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. in patients known to be hypersensitive to amphetamine, or other components of desoxyn. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine p

European Union - English - EMA (European Medicines Agency)

recordati rare diseases - osilodrostat phosphate - cushing syndrome - corticosteroids for systemic use - isturisa is indicated for the treatment of endogenous cushing’s syndrome in adults.

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

recordati rare diseases australia pty ltd - dinutuximab beta, quantity: 4.5 mg/ml - solution - excipient ingredients: polysorbate 20; hydrochloric acid; sucrose; water for injections; histidine - qarziba is indicated for the treatment of high-risk neuroblastoma in patients who have previously received induction chemotherapy and achieved at least a partial response.

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

recordati industria chimica e farmaceutica s.p.a. - fenticonazole (fenticonazole nitrate) - cream for vaginal and external use - 20mg/g

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

recordati rare diseases, inc. - pasireotide (unii: 98h1t17066) (pasireotide - unii:98h1t17066) - signifor is indicated for the treatment of adult patients with cushing's disease for whom pituitary surgery is not an option or has not been curative. none. risk summary the limited data with signifor in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in embryo-fetal development studies in rabbits, findings indicating developmental delay were observed with subcutaneous administration of pasireotide during organogenesis at doses less than the exposure in humans at the highest recommended dose; maternal toxicity was not observed at this dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. data animal data in embryo-fetal development studies in rats given 1, 5, and 10 mg/kg/day subcutaneously throughout org

Ireland - English - HPRA (Health Products Regulatory Authority)

casen-recordati s.l. - sodium picosulfate; light magnesium oxide; citric acid anhydrous - powder for oral solution in sachet - 10,3.5,10.97 gram(s) - contact laxatives; sodium picosulfate, combinations

Ireland - English - HPRA (Health Products Regulatory Authority)

casen-recordati s.l. - macrogol 4000 - powder for oral solution - 10 gram(s) - osmotically acting laxatives; macrogol - drugs for constipation. osmotically acting laxatives - symptomatic treatment of constipation in adults and children aged 8 years and above