União Europeia - português - EMA (European Medicines Agency)

gentium s.r.l. - desfibrotida - doença veno-oclusiva hepatica - agentes antitrombóticos - defitelio é indicado para o tratamento de doença veno-oclusiva hepática grave (vod) também conhecida como síndrome obstrutiva sinusoidal (sos) na terapia de transplante de células-tronco hematopoiéticas (hsct). É indicado em adultos e em adolescentes, crianças e bebês mais de 1 mês de idade.

União Europeia - português - EMA (European Medicines Agency)

leti pharma, s.l.u. - recombinant protein q from leishmania infantum mon-1 - inativadas vacinas bacterianas (incluindo mycoplasma, tetânico e clamídia) - cães - para imunização ativa de cães a partir de 6 meses de idade para reduzir o risco de desenvolver um caso clínico de leishmaniose.

União Europeia - português - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - lenalidomida - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - imunossupressores - vários myelomarevlimid como monoterapia é indicado para o tratamento de manutenção de pacientes adultos diagnosticados com mieloma múltiplo que tenham sido submetidos a transplante de células-tronco autólogas. revlimid como a terapia de combinação com dexametasona, ou o bortezomib e dexametasona, ou melfalano e prednisona (ver secção 4,. 2) é indicado para o tratamento de pacientes adultos não tratados previamente com mieloma múltiplo que não são elegíveis para transplante. revlimid em combinação com dexametasona é indicado para o tratamento de mieloma múltiplo em pacientes adultos que receberam pelo menos uma terapêutica prévia. mielodisplásicas syndromesrevlimid como monoterapia é indicado para o tratamento de pacientes adultos com dependência de transfusões de anemia devido à baixa ou intermediária-1-risco de síndromes mielodisplásicas associado a um isolado de exclusão 5q anormalidade citogenética quando outras opções terapêuticas são insuficientes ou inadequadas. de células do manto lymphomarevlimid como monoterapia é indicado para o tratamento de pacientes adultos com recidivado ou refratário linfoma de células do manto. folicular lymphomarevlimid em combinação com rituximab (anti-cd20 de anticorpos) é indicado para o tratamento de doentes adultos tratados previamente folicular linfoma (grau 1 – 3a).

União Europeia - português - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - efavirenz - infecções por hiv - antivirais para uso sistêmico - sustiva é indicado no tratamento de combinação antiviral de adultos, adolescentes e crianças com três anos de idade infectados por vírus da imunodeficiência humana (hiv-1). sustiva não foi adequadamente estudada em pacientes com doença avançada pelo hiv, nomeadamente em pacientes com contagens de cd4 + < 50 células/mm3, ou após uma falha de protease-inibidor (pi)-regimes contendo. embora a resistência cruzada do efavirenz com pis não foi documentada, atualmente existem dados suficientes sobre a eficácia do uso posterior de pi terapia de combinação baseada em, após falha de regimes contendo sustiva.

União Europeia - português - 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.

União Europeia - português - EMA (European Medicines Agency)

baxalta innovations gmbh - nonacog gamma - hemofilia b - anti-hemorrágicos - tratamento e profilaxia do sangramento em pacientes com hemofilia b (deficiência congênita de factor ix).

União Europeia - português - EMA (European Medicines Agency)

octapharma ab - simoctocog alfa - hemofilia a - anti-hemorrágicos - tratamento e profilaxia do sangramento em pacientes com hemofilia a (deficiência congênita de fator viii). vihuma pode ser usado para todos os grupos de idade.

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

bristol-myers squibb farmacÊutica ltda - antinflamatorios

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

bristol-myers squibb farmacÊutica ltda - nadolol - agentes betabloqueadores

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

bristol-myers squibb farmacÊutica ltda - emolientes e protetores da pele e mucosas