União Europeia - português - EMA (European Medicines Agency)

holostem s.r.l - células epiteliais corneanas humanas autólogas expandidas ex vivo que contêm células estaminais - stem cell transplantation; corneal diseases - oftalmológicos - tratamento de pacientes adultos com deficiência de células estaminais limbo moderadas a graves (definidos pela presença de neovascularização corneana superficial em pelo menos dois quadrantes corneanos, com comprometimento corneano central e gravidade visual severa), unilateral ou bilateral, devido a ocular física ou química queima. um mínimo de 1-2 mm2 de limbo não danificado é necessário para biópsia.

União Europeia - português - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - agentes antineoplásicos - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pacientes com egfr ou alk positivo tumor mutações também deve ter recebido a terapia direcionada antes de receber keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

União Europeia - português - EMA (European Medicines Agency)

vericel denmark aps - condócitos cultivados autólogos - fraturas, cartilagem - outras drogas para distúrbios do sistema músculo-esquelético - reparação de defeitos de cartilagem sintomática do joelho.

União Europeia - português - EMA (European Medicines Agency)

roche registration gmbh - epoetina beta - kidney failure, chronic; anemia; cancer; blood transfusion, autologous - preparações antianêmicas - tratamento de anemia sintomática associada à insuficiência renal crónica (irc) em doentes adultos e pediátricos;tratamento de anemia sintomática em doentes adultos com não-neoplasias mielóides a receber quimioterapia;aumentar a colheita de sangue autólogo em pacientes em um programa de doação prévia. a sua utilização nesta indicação deve ser equilibrado com o relatado aumento do risco de eventos tromboembólicos. o tratamento só deve ser administrado a doentes com anemia moderada (hb 10 - 13 g/dl [6. 21 - 8. 07 mmol/l], sem deficiência de ferro) se processos de conservação de sangue não estão disponíveis ou forem insuficientes quando a grande cirurgia electiva programada requer um grande volume de sangue (4 ou mais unidades de sangue por mulheres ou 5 ou mais unidades para homens).

União Europeia - português - EMA (European Medicines Agency)

pfizer europe ma eeig - epoetina zeta - anemia; blood transfusion, autologous; kidney failure, chronic; cancer - outras preparações antianemic - tratamento de anemia sintomática associada à insuficiência renal crónica (irc) em doentes adultos e pediátricos:o tratamento da anemia associada à insuficiência renal crónica em doentes adultos e pediátricos em hemodiálise e pacientes adultos em diálise peritoneal;tratamento da anemia grave, de origem renal, acompanhada por sintomas clínicos em pacientes adultos com insuficiência renal ainda não submetidos a diálise. tratamento de anemia e redução de transfusão de requisitos em doentes adultos a receber quimioterapia para tumores sólidos, linfoma maligno ou mieloma múltiplo e em risco de transfusão de acordo com a avaliação do paciente estado geral (e. cardiovascular pré-existente anemia no início da quimioterapia). retacrit pode ser usado para aumentar o rendimento de sangue autólogo em pacientes em um programa predonation. a sua utilização nesta indicação deve ser equilibrado com o relatado risco de eventos tromboembólicos. o tratamento só deve ser administrado a doentes com anemia moderada (sem deficiência de ferro), se o sangue de poupança de procedimentos não estiverem disponíveis ou forem insuficientes quando a grande cirurgia electiva programada requer um grande volume de sangue (de quatro ou mais unidades de sangue para o sexo feminino, cinco ou mais unidades para homens). retacrit pode ser usado para reduzir a exposição a alogênico de transfusões de sangue em adultos não-ferro-deficiente pacientes antes de grande cirurgia ortopédica electiva, tendo uma alta percepção de risco para complicações da transfusão de. uso deve ser restrito a pacientes com anemia moderada (e. hb 10 a 13 g/dl) que não têm uma autólogo predonation programa disponível e com uma expectativa moderada perda de sangue (900 a 1800 ml).

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)

stada arzneimittel ag - epoetina zeta - anemia; blood transfusion, autologous; cancer; kidney failure, chronic - preparações antianêmicas - tratamento de anemia sintomática associada à insuficiência renal crônica (irc) em adultos e pediátricos patientstreatment da anemia associada à insuficiência renal crónica em doentes adultos e pediátricos em hemodiálise e pacientes adultos em diálise peritoneal. tratamento da anemia grave, de origem renal, acompanhada por sintomas clínicos em pacientes adultos com insuficiência renal ainda não submetidos a diálise. tratamento de anemia e redução de transfusão de requisitos em doentes adultos a receber quimioterapia para tumores sólidos, linfoma maligno ou mieloma múltiplo e em risco de transfusão de acordo com a avaliação do paciente estado geral (e. cardiovascular pré‑existente anemia no início da quimioterapia). silapo pode ser usado para aumentar o rendimento de sangue autólogo em pacientes em um programa predonation. a sua utilização nesta indicação deve ser equilibrado com o relatado risco de eventos tromboembólicos. o tratamento só deve ser administrado a doentes com anemia moderada (sem deficiência de ferro), se o sangue de verão procedimentos não estiverem disponíveis ou forem insuficientes quando a grande cirurgia electiva programada requer um grande volume de sangue (4 ou mais unidades de sangue por mulheres ou 5 ou mais unidades para homens). silapo é indicado para utilização não-deficiência de ferro em adultos antes de grande cirurgia ortopédica electiva ter uma alta percepção de risco para complicações da transfusão de reduzir a exposição a transfusões de sangue alogênico. uso deve ser restrito a pacientes com anemia moderada (e. concentração de hemoglobina entre 10 a 13 g/dl) que não têm uma autólogo predonation programa disponível e com uma expectativa moderada perda de sangue (900 1 800 ml). silapo pode ser usada para aumentar a concentração de hemoglobina no anemia sintomática (concentração de hemoglobina ≤10 g/dl em adultos com baixo ou intermediário-1-risco primário síndromes mielodisplásicas (smd), que têm baixos de eritropoetina sérica (.

União Europeia - português - EMA (European Medicines Agency)

co.don gmbh - esferóides de condrócitos associados à matriz autóloga humana - doenças da cartilagem - outras drogas para distúrbios do sistema músculo-esquelético - reparação de defeitos de cartilagem articular sintomática do côndilo femoral e da rótula do joelho (international cartilage repair society [icrs] grau iii ou iv) com defeitos de até 10 cm2 em adultos.

União Europeia - português - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - carmustine - hodgkin disease; lymphoma, non-hodgkin - agentes antineoplásicos - carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, secondary therapy in non-hodgkin’s lymphoma and hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (hpct) in malignant haematological diseases (hodgkin’s disease / non-hodgkin’s lymphoma).

União Europeia - português - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomida - mieloma múltiplo - imunossupressores - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide accord 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. a lenalidomida acordo, em combinação com dexametasona é indicado para o tratamento de mieloma múltiplo em pacientes adultos que receberam pelo menos uma terapêutica prévia. follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).