Unione Europea - portoghese - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - atazanavir (as sulfate) - infecções por hiv - antivirais para uso sistêmico - as cápsulas de reyataz, co-administradas com doses baixas de ritonavir, são indicadas para o tratamento de adultos infectados com hiv-1 e doentes pediátricos de 6 anos ou mais em combinação com outros medicamentos anti-retrovirais (ver secção 4. 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 reyataz 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 (ver seções 4. 4 e 5. reyataz oral pó, co-administrado com baixa dose de ritonavir, é indicado em combinação com outros medicamentos anti-retrovirais para o tratamento do hiv-1 em pacientes pediátricos infectados pelo menos 3 meses de idade e pesando, no mínimo, 5 kg (ver secção 4,. 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 reyataz 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 (ver seções 4. 4 e 5.

Unione Europea - portoghese - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - talidomida - mieloma múltiplo - imunossupressores - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.

Unione Europea - portoghese - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - azacitidina - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - agentes antineoplásicos - vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with: intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification. vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for hsct with aml with >30% marrow blasts according to the who classification.

Unione Europea - portoghese - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ozanimod cloridrato de - multiple sclerosis, relapsing-remitting; colitis, ulcerative - imunossupressores - multiple sclerosiszeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features. ulcerative colitiszeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Unione Europea - portoghese - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - agentes antineoplásicos - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Unione Europea - portoghese - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - mavacamten - cardiomyopathy, hypertrophic - outros preparações cardíacas - treatment of symptomatic obstructive hypertrophic cardiomyopathy.

Unione Europea - portoghese - EMA (European Medicines Agency)

bristol-myers squibb / pfizer eeig - apixaban - arthroplasty; venous thromboembolism - agentes antitrombóticos - para eliquis 2. 5 mg comprimidos revestidos por película:prevenção de eventos tromboembólicos venosos (tev) em pacientes adultos que foram submetidos a eletiva de substituição de quadril ou joelho cirurgia. prevenção de avc e embolia sistêmica em pacientes adultos com fibrilação atrial não valvar fibrilação (nvaf), com um ou mais fatores de risco, tais como antecedentes de acidente vascular cerebral ou transitória isquêmico ataque (tia); idade ≥ 75 anos; hipertensão arterial; diabetes mellitus; sintomático da insuficiência cardíaca (nyha classe ≥ ii). tratamento da trombose venosa profunda (tvp) e embolia pulmonar (pe), e na prevenção da tvp recorrente e pe em adultos (ver secção 4,. 4 para haemodynamically instável pe pacientes). para eliquis 5 mg comprimidos revestidos por película:prevenção de avc e embolia sistêmica em pacientes adultos com fibrilação atrial não valvar fibrilação (nvaf), com um ou mais fatores de risco, tais como antecedentes de acidente vascular cerebral ou transitória isquêmico ataque (tia); idade≥ 75 anos; hipertensão arterial; diabetes mellitus; sintomático da insuficiência cardíaca (nyha classe ≥ ii). tratamento da trombose venosa profunda (tvp) e embolia pulmonar (pe), e na prevenção da tvp recorrente e pe em adultos (ver secção 4,. 4 para haemodynamically instável pe pacientes).

Unione Europea - portoghese - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - elotuzumab - mieloma múltiplo - agentes antineoplásicos - empliciti é indicado em combinação com a lenalidomida e dexametasona para o tratamento de mieloma múltiplo em pacientes adultos que receberam pelo menos uma antes da terapia (ver seções 4. 2 e 5.

Unione Europea - portoghese - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - agentes antineoplásicos - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Unione Europea - portoghese - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - agentes antineoplásicos - sprycel é indicado para o tratamento de pacientes pediátricos com:recém-diagnosticado, o cromossoma filadélfia positivo mielóide crônica leucemia em fase crônica (lmc ph+ cp) ou lmc ph+ cp resistentes ou intolerantes antes da terapia, incluindo o imatinib. recém-diagnosticados ph+ leucemia linfoblástica aguda (all) em combinação com a quimioterapia. sprycel é indicado para o tratamento de pacientes adultos com:recém-diagnosticados filadélfia-cromossomo-positivo (ph+) mielóide crônica, leucemia (cml) na fase crônica;crônica, acelerada ou blástica lmc em fase com resistência ou intolerância à terapêutica prévia, incluindo o imatinib mesilate;ph+ leucemia linfoblástica aguda (all) e linfóide explosão de lmc com resistência ou intolerância à terapêutica prévia. sprycel é indicado para o tratamento de pacientes pediátricos com:recém-diagnosticados lmc ph+ em fase crônica (lmc ph+ cp) ou lmc ph+-cp resistentes ou intolerantes antes da terapia, incluindo o imatinib.