União Europeia - português - EMA (European Medicines Agency)

krka, d.d., novo mesto - atazanavir (as sulfate) - infecções por hiv - antivirais para uso sistêmico - atazanavir krka cápsulas, co-administrado com baixa dose de ritonavir, são indicados para o tratamento de hiv-1 em adultos infectados e pacientes pediátricos de 6 anos de idade e mais velhos em combinação com outros medicamentos anti-retrovirais. com base no disponível virológica e os dados clínicos de pacientes adultos, nenhum benefício é esperado em pacientes com cepas resistentes a várias inibidores de protease (≥ 4 pi mutações). a escolha do atazanavir krka no tratamento experientes adultos e pacientes pediátricos deve ser de acordo com os testes de resistência viral e o paciente em tratamento com a história.

União Europeia - português - EMA (European Medicines Agency)

teva b.v. - salmeterol xinafoate, fluticasone propionate - asma - medicamentos para obstrutiva, doenças das vias respiratórias, - bropair spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β₂ agonists.

União Europeia - português - EMA (European Medicines Agency)

teva b.v. - fluticasone propionate, salmeterol xinafoate - asma - medicamentos para obstrutiva, doenças das vias respiratórias, - seffalair spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β₂ agonists.

União Europeia - português - EMA (European Medicines Agency)

koanaa healthcare gmbh - o imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - agentes antineoplásicos - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. os pacientes que têm um baixo ou muito baixo risco de recorrência não deve receber tratamento adjuvante. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. exceto em recém-diagnosticados lmc em fase crónica, não há ensaios clínicos controlados demonstrando um benefício clínico ou aumento da sobrevivência para essas doenças.

União Europeia - português - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - esclerose múltipla remitente-recorrente envio - imunossupressores - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

União Europeia - português - EMA (European Medicines Agency)

serb sas - glucarpidase - metabolic side effects of drugs and substances - todos os outros produtos terapêuticos - voraxaze is indicated to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity.

União Europeia - português - EMA (European Medicines Agency)

mylan ireland limited - fumarato de dimetilo - esclerose múltipla remitente-recorrente envio - imunossupressores - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

União Europeia - português - EMA (European Medicines Agency)

zaklady farmafarmaceutyczne polpharma s.aceutyczne polpharma s.a. - fumarato de dimetilo - esclerose múltipla remitente-recorrente envio - imunossupressores - dimethyl fumarate polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

União Europeia - português - EMA (European Medicines Agency)

laboratorios lesvi s.l. - fumarato de dimetilo - esclerose múltipla remitente-recorrente envio - imunossupressores - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Portugal - português - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

look ahead srl - diclofenac - gel - 50 mg/g - diclofenac sódico 50 mg/g - diclofenac - n/a - duração do tratamento: curta ou média duração