União Europeia - português - EMA (European Medicines Agency)

opk biotech netherlands bv - hemoglobina glutamer-200 (bovina) - substitutos de sangue e soluÇÕes para perfusÃo - cães - o oxiglobina fornece suporte oxigenador para cães, melhorando os sinais clínicos de anemia durante pelo menos 24 horas, independentemente da condição subjacente.

União Europeia - português - EMA (European Medicines Agency)

ceva-phylaxia co. ltd. - vírus de herpes de peru recombinante vivo associado a células (rhvt / nd) que expressa a proteína de fusão da linhagem lentogênica do vírus das doenças de newcastle d-26 - imunológicos para aves, ao vivo viral vacinas - chicken; embryonated eggs - para a imunização ativa de 18 dias embryonated de frango, ovos ou pintos do dia para reduzir a mortalidade e sinais clínicos causados por vírus da doença de newcastle e para reduzir a mortalidade, sinais clínicos e lesões causadas pelo vírus da doença de marek, com um fenótipo "virulento".

União Europeia - português - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (como fosfato) - myeloproliferative disorders; polycythemia vera; graft vs host disease - agentes antineoplásicos - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. polycythaemia vera (pv)jakavi é indicado para o tratamento de pacientes adultos com polycythaemia vera que são resistentes ou intolerantes hydroxyurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

União Europeia - português - EMA (European Medicines Agency)

retrophin europe ltd - ácido cólico - metabolismo, erros inatos - terapia bilis e hepática - cholic Ácido fgk é indicado para o tratamento de erros inatos do principal ácido biliar síntese, em crianças de um mês de idade para a contínua ao longo da vida de tratamento até a idade adulta, abrangendo os seguintes única enzima defeitos:sterol 27-hydroxylase (apresentando-se como cerebrotendinous xanthomatosis, ctx) de deficiência;2- (ou alfa) methylacyl-coa racemase (amacr) a deficiência de colesterol 7-alfa-hydroxylase (cyp7a1) deficiência.

União Europeia - português - EMA (European Medicines Agency)

pharmathen s.a. - cloridrato de memantina - doença de alzheimer - psychoanaleptics, , outros anti-demência drogas - tratamento de pacientes com doença de alzheimer moderada a grave.

União Europeia - português - EMA (European Medicines Agency)

sanofi winthrop industrie - clopidogrel hidrogen sulfato - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - agentes antitrombóticos - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six 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 patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic 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. prevenção de aterotrombóticos e de eventos tromboembólicos em atrial fibrillationin pacientes adultos com fibrilação atrial que tenham pelo menos um fator de risco para eventos vasculares não são adequados para o tratamento com vitamina-k antagonistas e que têm um baixo risco de sangramento, o clopidogrel é indicado em combinação com asa para a prevenção de aterotrombóticos e eventos tromboembólicos, incluindo acidente vascular cerebral.

União Europeia - português - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

União Europeia - português - EMA (European Medicines Agency)

merck sharp & dohme b.v. - fosfato de tedizólido - soft tissue infections; skin diseases, bacterial - antibacterials for systemic use, , other antibacterials - sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and adolescents 12 years of age and older.

União Europeia - português - EMA (European Medicines Agency)

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatite c, crônica - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 e 5. para o vírus da hepatite c (vhc) genótipo-actividade específica, consulte as secções 4. 4 e 5.

União Europeia - português - EMA (European Medicines Agency)

leo pharma a/s - tacrolimus - dermatite, atopic - outras preparações dermatológicas - flare treatmentadults and adolescents (16 years of age and above)treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. children (two years of age and above)treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. maintenance treatmentmaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i. ocorrência de quatro ou mais vezes por ano), que tiveram uma resposta inicial a um máximo de seis semanas de tratamento duas vezes ao dia, pomada de tacrolimus (lesões limpo, quase limpo ou levemente afetados).