European Union - English - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - umeclidinium bromide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).,

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

care pharmaceuticals pty ltd - zinc oxide -

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

meda pharmaceuticals - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - astelin nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. limited data from postmarketing experience over decades of use with astelin in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose.  oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (mrhdid) of 1.096 mg. however, the relevance of these findings

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

physicians total care, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug - astelin® nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older. astelin® nasal spray is contraindicated in patients with a known hypersensitivity to azelastine hydrochloride or any of its components. for intranasal use only important: follow instructions carefully to ensure proper dosing. dosing: the dosage of astelin® nasal spray is 1 spray per nostril twice daily for pediatric patients (ages 5-11 years) with seasonal allergic rhinitis. for patients age 12 and older with seasonal allergic rhinitis the dosage is one or two sprays per nostril twice daily. for patients age 12 and older with nonallergic vasomotor rhinitis the dosage is two sprays per nostril twice daily. keep your head tilted downward when spraying. alternate s

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

novartis pharmaceuticals australia pty ltd - inclisiran, quantity: 284 mg - injection, solution - excipient ingredients: sodium hydroxide; phosphoric acid; water for injections - leqvio is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (ldl-c) in adults with heterozygous familial hypercholesterolaemia, atherosclerotic cardiovascular disease, or at high risk of a cardiovascular event:,? in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,,? alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant.

European Union - English - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - macimorelin acetate - diagnostic techniques, endocrine - macimorelin - this medicinal product is for diagnostic use only. ghryvelin is indicated for the diagnosis of growth hormone deficiency (ghd) in adults.

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

sun pharmaceutical industries, inc. - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with sjögren’s syndrome. cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.

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

aurobindo pharma limited - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with sjögren’s syndrome. cevimeline hydrochloride capsules are contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.

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

advagen pharma ltd - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline is indicated for the treatment of symptoms of dry mouth in patients with sjögren’s syndrome. cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.

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

bionpharma inc - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with sjögren’s syndrome. cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.