European Union - English - EMA (European Medicines Agency)

nova laboratories ireland limited - 6-mercaptopurine monohydrate - leukemia, lymphoid - antineoplastic agents - xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (all) in adults, adolescents and children.

European Union - English - EMA (European Medicines Agency)

nova laboratories ireland limited - hydroxycarbamide - anemia, sickle cell - antineoplastic agents - prevention of vaso-occlusive complications of sickle cell disease in patients over 2 years of age

European Union - English - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - graft rejection - immunosuppressants - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression).jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response.jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice.it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

European Union - English - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolactone - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension.neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2). 

Ireland - English - HPRA (Health Products Regulatory Authority)

norbrook laboratories (ireland) limited - eprinomectin - pour-on solution - 5 milligram(s)/millilitre - eprinomectin

Ireland - English - HPRA (Health Products Regulatory Authority)

norbrook laboratories (ireland) limited - eprinomectin - pour-on solution - 5 milligram(s)/millilitre - eprinomectin

Ireland - English - HPRA (Health Products Regulatory Authority)

norbrook laboratories (ireland) limited - thiamazole - oral solution - 5 milligram(s)/millilitre - thiamazole

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

inova pharmaceuticals (australia) pty ltd - tetrabenazine, quantity: 25 mg - tablet, uncoated - excipient ingredients: purified talc; iron oxide yellow; maize starch; lactose monohydrate; magnesium stearate - may be useful for the control of chorea, hemiballismus, tardive and buccolingual dyskinesias and certain dystonic syndromes.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 80 mg - tablet, modified release - excipient ingredients: polyethylene oxide; magnesium stearate; hypromellose; indigo carmine; hyprolose; polysorbate 80; iron oxide yellow; macrogol 400 - novacodone is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long term treatment. novacodone modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. novacodone is not indicated as an as-needed-(prn) analgesia.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 40 mg - tablet, modified release - excipient ingredients: magnesium stearate; polyethylene oxide; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; macrogol 400 - novacodone is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long term treatment. novacodone modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. novacodone is not indicated as an as-needed-(prn) analgesia.