European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole mylan pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole mylan pharma is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.aripiprazole mylan pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.

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

denton pharma, inc. dba northwind pharmaceuticals - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - indications and usage carefully consider the potential benefits and risks of naproxen and other treatment options before deciding to use naproxen tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings: gastrointestinal bleeding, ulceration, and perforation ). naproxen tablets are indicated: - for the relief of the signs and symptoms of rheumatoid arthritis - for the relief of the signs and symptoms of osteoarthritis - for the relief of the signs and symptoms of ankylosing spondylitis - for the relief of the signs and symptoms of juvenile arthritis naproxen tablets are also indicated: - for relief of the signs and symptoms of tendonitis - for relief of the signs and symptoms of bursitis - for relief of the signs and symptoms of acute gout - for the management of pain - for the management of primary dysmenorrhea contraindications naproxen tablets are contraindicated in the following patients: • known hypersensitivity (e.g., anaphylact

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

denton pharma, inc. dba northwind pharmaceuticals - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibuprofen tablets are indicated for relief of mild to moderate pain. ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see wa

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - temazepam 10mg; temazepam 10mg - tablet - 10 mg - active: temazepam 10mg excipient: lactose monohydrate magnesium stearate maize starch microcrystalline cellulose active: temazepam 10mg excipient: lactose monohydrate magnesium stearate maize starch microcrystalline cellulose sunset yellow aluminium lake - normison is indicated for use as a hypnotic or night-time sedative. as a hypnotic, normison is indicated for severe or disabling insomnia characterised by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakening. normison is indicated for use as a premedicant taken 30-60 minutes prior to surgical or other procedures.

European Union - English - EMA (European Medicines Agency)

taw pharma (ireland) limited - clopidogrel hydrochloride - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antithrombotic agents - , , , , secondary prevention of atherothrombotic events, , clopidogrel is indicated in: , - adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease., - adult patients suffering from acute coronary syndrome:,    - non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa).,     - st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy., , in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is), clopidogrel in combination with asa is indicated in:, - adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. , , prevention of atherothrombotic and thromboembolic events in atrial fibrillation, in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke., , for further information please refer to section 5.1. , , ,

European Union - English - EMA (European Medicines Agency)

takeda pharma a/s - fentanyl citrate - pain; cancer - analgesics - instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

European Union - English - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - agalsidase alfa - fabry disease - other alimentary tract and metabolism products, - replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of fabry disease (α-galactosidase-a deficiency).

European Union - English - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland - prucalopride succinate - constipation - other drugs for constipation - resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.

European Union - English - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - idursulfase - mucopolysaccharidosis ii - other alimentary tract and metabolism products, - elaprase is indicated for the long-term treatment of patients with hunter syndrome (mucopolysaccharidosis ii, mps ii). heterozygous females were not studied in the clinical trials.

European Union - English - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - hydrocortisone - adrenal insufficiency - corticosteroids for systemic use - treatment of adrenal insufficiency in adults.