União Europeia - português - EMA (European Medicines Agency)

orion corporation - dexmedetomidine hydrochloride - sedação consciente - psicolepticos - para a sedação de unidades de terapia intensiva para adultos que requerem um nível de sedação não mais profundo do que a excitação em resposta à estimulação verbal (correspondente à escala de agitação-sedação de richmond (rass) 0 a -3).

União Europeia - português - EMA (European Medicines Agency)

merz pharmaceuticals gmbh   - cloridrato de memantina - doença de alzheimer - outros medicamentos anti-demência - tratamento de pacientes com doença de alzheimer moderada a grave.

União Europeia - português - EMA (European Medicines Agency)

dipharma arzneimittel gmbh - sapropterin dihydrochloride - fenilcetonurias - outro aparelho digestivo e metabolismo produtos, - sapropterin dipharma is indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with phenylketonuria (pku) who have been shown to be responsive to such treatment. sapropterin dipharma is also indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with tetrahydrobiopterin (bh4) deficiency who have been shown to be responsive to such treatment.

União Europeia - português - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - carcinoma, pulmão de células não pequenas - agentes antineoplásicos - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

União Europeia - português - EMA (European Medicines Agency)

gilead sciences ireland uc - a emtricitabina, rilpivirine hydrochloride, tenofovir alafenamide - infecções por hiv - antivirais para uso sistêmico - tratamento de adultos e adolescentes (com idade igual ou superior a 12 anos com peso corporal de pelo menos 35 kg) infectados com vírus da imunodeficiência humana 1 (hiv 1) sem mutações conhecidas associadas à resistência à classe de inibidor de transcriptase reversa não nucleósida (nnrti), tenofovir ou emtricitabina e com uma carga viral ≤ 100,000 cópias de arn do hiv 1 / ml.

União Europeia - português - EMA (European Medicines Agency)

lupin europe gmbh - mexiletine hydrochloride - miotônica transtornos - terapia cardíaca - namuscla é indicado para o tratamento sintomático da miotonia em pacientes adultos com não-distrófico miotônica transtornos.

União Europeia - português - EMA (European Medicines Agency)

yes pharmaceutical development services gmbh - cloridrato de doxorrubicina - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - agentes antineoplásicos - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

União Europeia - português - EMA (European Medicines Agency)

orion corporation - ropinirole hydrochloride - agentes dopaminérgicos, agonistas da dopamina - cães - a indução de vômitos em cães.

União Europeia - português - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - imunossupressores - multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) é indicado para o tratamento de pacientes adultos não tratados previamente com mieloma múltiplo que não são elegíveis para transplante. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) é indicado para o tratamento de pacientes adultos não tratados previamente com mieloma múltiplo que não são elegíveis para transplante. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

União Europeia - português - 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.