União Europeia - português - EMA (European Medicines Agency)

viatris limited - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - imunossupressores - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

União Europeia - português - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drogas usadas em diabetes - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 e 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

União Europeia - português - EMA (European Medicines Agency)

viatris limited - clopidogrel besilate - peripheral vascular diseases; stroke; myocardial infarction - agentes antitrombóticos - secondary prevention of atherothrombotic events clopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischemic 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). segmento st elevação infarto agudo do miocárdio, em combinação com asa em medicamente tratados os pacientes elegíveis para terapia trombolítica. 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. para mais informações, por favor consulte a secção 5.

União Europeia - português - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - agentes antitrombóticos - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

União Europeia - português - EMA (European Medicines Agency)

mylan pharmaceuticals limited - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - agentes antitrombóticos - clopidogrel/ácido acetilsalicílico mylan é indicado para a prevenção secundária de eventos aterotrombóticos em pacientes adultos já de tomar clopidogrel e ácido acetilsalicílico (asa). clopidogrel/ácido acetilsalicílico mylan é uma combinação de dose fixa medicamento para a continuação da terapia em:sem elevação de segmento st de síndrome coronariana aguda (angina instável ou não-q-onda de infarto do miocárdio), incluindo pacientes submetidos a uma colocação de stent seguinte coronária percutânea interventionst segmento de elevação de infarto agudo do miocárdio em doentes tratados medicamente elegíveis para terapia trombolítica.

União Europeia - português - EMA (European Medicines Agency)

mylan pharmaceuticals limited - anagrelide cloridrato de - trombocitemia, essencial - agentes antineoplásicos - anagrelide é indicado para a redução das elevadas contagens de plaquetas em risco essenciais thrombocythaemia (et), os pacientes que são intolerantes ao seu atual terapia ou cuja elevadas contagens de plaquetas não são reduzidos para um nível aceitável, por sua actual terapêutica. an at-risk patientan at-risk essential thrombocythaemia patient is defined by one or more of the following features:>60 years of age ora platelet count >1,000 x 10⁹/l ora history of thrombo-haemorrhagic events.

União Europeia - português - EMA (European Medicines Agency)

mylan pharmaceuticals limited - prasugrel besilate - myocardial infarction; acute coronary syndrome; angina, unstable - agentes antitrombóticos - prasugrel mylan, co-administrado com ácido acetilsalicílico (asa), é indicada para a prevenção de eventos aterotrombóticos em pacientes adultos com síndrome coronariana aguda (eu. angina instável, não-elevação de segmento st infarto do miocárdio [ua/nstemi] ou elevação de segmento st infarto do miocárdio [stemi]) submetidos primária ou atrasada a intervenção coronária percutânea (pci).

União Europeia - português - EMA (European Medicines Agency)

mylan pharmaceuticals limited - monohidrato de entecavir - hepatite b - antivirais para uso sistêmico - entecavir mylan is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. descompensada, doença hepática. para tanto compensada e descompensada, doença hepática, esta indicação é baseada em dados de ensaios clínicos em análogos de ingênuo pacientes com hbeag positivo e hbeag negativo da infecção pelo vhb. em relação aos pacientes com hepatite b refratária à lamivudina. entecavir mylan é também indicado para o tratamento da infecção crônica pelo vhb em análogos de ingênuo pacientes pediátricos de 2 a.

União Europeia - português - EMA (European Medicines Agency)

mylan pharmaceuticals limited - febuxostat - hyperuricemia; arthritis, gouty; gout - antigout preparações - febuxostat mylan é indicado para a prevenção e tratamento de hiperuricemia em pacientes adultos submetidos a quimioterapia para doenças malignas hematológicas de risco intermediário a alto de síndrome de lise tumoral (tls). febuxostat mylan é indicado para o tratamento de doenças crônicas hyperuricaemia em condições onde a deposição de urato já ocorreu (incluindo uma história, ou a presença de, tophus e/ou artrite gotosa). febuxostat mylan é indicado em adultos.

União Europeia - português - EMA (European Medicines Agency)

mylan pharmaceuticals limited - cloridrato de memantina - doença de alzheimer - other anti-dementia drugs, psychoanaleptics, - tratamento de pacientes com doença de alzheimer moderada a grave.