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

azurity pharmaceuticals, inc. - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - amphetamine sulfate 5 mg - evekeo® (amphetamine sulfate tablets, usp) is indicated for: - narcolepsy - attention deficit disorder with hyperactivity 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 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 the 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 not be warranted. - exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group pro

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

amgen inc - romosozumab (unii: 3vhf2zd92j) (romosozumab - unii:3vhf2zd92j) - evenity is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.  the anabolic effect of evenity wanes after 12 monthly doses of therapy. therefore, the duration of evenity use should be limited to 12 monthly doses. if osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered [see dosage and administration ( 2.2 ) and clinical studies ( 14.1 )] . evenity is contraindicated in patients with: - hypocalcemia. pre-existing hypocalcemia must be corrected prior to initiating therapy with evenity [ see warnings and precautions ( 5.3 ) , adverse reactions ( 6.1 ) and use in specific populations ( 8.7 )] . - a history of systemic hypersensitivity to romosozumab or to any component of the product formulation. reactions have included angioedema, erythema m

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

azurity pharmaceuticals, inc. - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - evekeo odt is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in pediatric patients 6 to 17 years of age. evekeo odt is contraindicated in patients: - with known hypersensitivity to amphetamine, or other components of evekeo odt. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see adverse reactions (6.2)] . - receiving concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi (including maois such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see warnings and precautions (5.8), drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including evekeo odt, during pregnancy. healthcare providers are encouraged to register patients by calling the national

Israel - English - Ministry of Health

amgen europe b.v. - romosozumab - solution for injection - romosozumab 90 mg / 1 ml - romosozumab - evenity is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

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

every man jack - pyrithione zinc (unii: r953o2rhz5) (pyrithione zinc - unii:r953o2rhz5) - anti dandruff - for relief of flaking and itching due to dandruff and seborrheic dermatitis , and to help prevent their recurrence.

Philippines - English - FDA (Food And Drug Administration)

nobel vet, inc.; distributor: nobel vet, inc. - live classical swine fever (csf) virus vaccine (vet.) - freeze-dried powder for injection (im) - formulation: each 1 ml (dose) contains: classical swine fever virus (lom-e strain) .................>10^3 tcid50 tcid - tissue culture infective dose

European Union - English - EMA (European Medicines Agency)

ucb pharma s.a. - romosozumab - osteoporosis - drugs for treatment of bone diseases - evenity is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

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

amgen australia pty ltd - romosozumab, quantity: 105 mg - injection, solution - excipient ingredients: calcium; polysorbate 20; sucrose; water for injections; sodium hydroxide; acetate - evenity is indicated for:,- the treatment of osteoporosis in postmenopausal women at high risk of fracture (see section 5.1 pharmacodynamic properties, clinical trials).,- treatment to increase bone mass in men with osteoporosis at high risk of fracture.

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - yellow fever virus 17 d-204 strain - suspension for injection - 1000 - yellow fever vaccines

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - yellow fever, virus strain, d - powder and solvent for suspension for injection - yellow fever virus strain 17d 1000 iu - vaccines