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

novel laboratories, inc. - phenelzine sulfate (unii: 2681d7p965) (phenelzine - unii:o408n561gf) - phenelzine 15 mg - phenelzine sulfate tablets, usp has been found to be effective in depressed patients clinically characterized as “atypical,” “nonendogenous,” or “neurotic.” these patients often have mixed anxiety and depression and phobic or hypochondriacal features. there is less conclusive evidence of its usefulness with severely depressed patients with endogenous features. phenelzine sulfate tablets should rarely be the first antidepressant drug used. rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions. phenelzine sulfate tablets should not be used in patients who are hypersensitive to the drug or its ingredients, with pheochromocytoma, congestive heart failure, severe renal impairment or renal disease, a history of liver disease, or abnormal liver function tests. the potentiation of sympathomimetic substances and related compounds by mao inhibitors may result in hypertensive crises (see warnings). therefore, patients being treated with phenelzi

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

novel laboratories, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 2.5 mg - attention  deficit  disorders , narcolepsy attention  deficit  disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride chewable 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 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 centra

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

nova pharmaceuticals australasia pty ltd - levonorgestrel, quantity: 1.5 mg - tablet, uncoated - excipient ingredients: maize starch; povidone; magnesium stearate; colloidal anhydrous silica; pregelatinised starch; lactose monohydrate; ethanol - emergency contraception within 72 hours of unprotected intercourse.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - midazolam maleate 20.8mg equivalent to 15 mg midazolam - tablet - 15 mg - active: midazolam maleate 20.8mg equivalent to 15 mg midazolam excipient: lactose monohydrate magnesium stearate maize starch microcrystalline cellulose

European Union - English - EMA (European Medicines Agency)

eisai gmbh - rufinamide - epilepsy - antiepileptics, - inovelon is indicated as adjunctive therapy in the treatment of seizures associated with lennox gastaut syndrome in patients 4 years of age and older.

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

gilead sciences pty ltd - tenofovir alafenamide fumarate, quantity: 11.2 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; hyprolose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; microcrystalline cellulose; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - genvoya is indicated as a single tablet regimen for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment?na?ve; or virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see 5.1 pharmacodynamic properties, clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of genvoya. genvoya is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

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

southern cross pharma pty ltd - roxithromycin, quantity: 150 mg - tablet, film coated - excipient ingredients: povidone; sodium starch glycollate type a; glucose; purified talc; hypromellose; maize starch; sodium starch glycollate type b; propylene glycol; hyprolose; poloxamer; titanium dioxide; colloidal anhydrous silica; magnesium stearate - adults: roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections caused by or likely to be caused by susceptible microorganisms: upper respiratory tract infection: acute pharyngitis, tonsillitis and sinusitis. lower respiratory tract infection: acute bronchitis and acute exacerbations of chronic bronchitis; community acquired pneumonia. skin and skin structure infections. nongonococcal urethritis. children: roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible microorganisms: acute pharyngitis. acute tonsillitis, impetigo. appropriate culture and sensitivity tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

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

gilead sciences pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: hyprolose; lactose monohydrate; microcrystalline cellulose; silicon dioxide; croscarmellose sodium; magnesium stearate; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - stribild is indicated as a single tablet regimen for the treatment of hiv infection in treatment-na?ve adults. stribild is also indicated in certain virologically suppressed (hiv1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of stribild (tenofovir df, emtricitabine or elvitegravir). stribild is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

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

alphapharm pty ltd - roxithromycin, quantity: 300 mg - tablet, film coated - excipient ingredients: povidone; hyprolose; maize starch; poloxamer; colloidal anhydrous silica; purified talc; magnesium stearate; glucose; titanium dioxide; hypromellose; propylene glycol - adults: roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections in adults caused by or likely to be caused by susceptible micro-organisms: upper respiratory tract infection: acute pharyngitis, tonsillitis, and sinusitis. lower respiratory tract infection: acute bronchitis and acute exacerbation of chronic bronchitis; community acquired pneumonia. skin and skin structure infections. non-gonococcal urethritis. children: roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children weighing greater than 40 kg caused by or likely to be caused by susceptible micro-organisms: acute pharyngitis. acute tonsillitis. impetigo. appropriate culture and sensitivity tests should be performed when necessary to determine an organisms susceptibility and thus treatment suitability. therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

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

alphapharm pty ltd - roxithromycin, quantity: 150 mg - tablet, film coated - excipient ingredients: povidone; hyprolose; maize starch; poloxamer; colloidal anhydrous silica; purified talc; magnesium stearate; glucose; titanium dioxide; hypromellose; propylene glycol - adults: roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections in adults caused by or likely to be caused by susceptible micro-organisms: upper respiratory tract infection: acute pharyngitis, tonsillitis, and sinusitis. lower respiratory tract infection: acute bronchitis and acute exacerbation of chronic bronchitis; community acquired pneumonia. skin and skin structure infections. non-gonococcal urethritis. children: roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children weighing greater than 40 kg caused by or likely to be caused by susceptible micro-organisms: acute pharyngitis. acute tonsillitis. impetigo. appropriate culture and sensitivity tests should be performed when necessary to determine an organisms susceptibility and thus treatment suitability. therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.