União Europeia - português - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

União Europeia - português - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibrose cística - outros produtos do sistema respiratório - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 e 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 e 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

União Europeia - português - EMA (European Medicines Agency)

janssen-cilag international nv - doripenem - pneumonia, ventilator-associated; pneumonia, bacterial; urinary tract infections; bacterial infections; cross infection - antibacterianos para uso sistémico, - doribax é indicado para o tratamento das seguintes infecções em adultos:pneumonia nosocomial (incluindo pneumonia associada à ventilação mecânica);complicadas, infecções intra-abdominais;complicados de infecções do trato urinário. deve ser tido em consideração a orientação oficial sobre o uso apropriado de agentes antibacterianos..

União Europeia - português - EMA (European Medicines Agency)

amgen europe b.v. - pegfilgrastim - neutropenia - immunostimulants, - redução da duração da neutropenia e da incidência de neutropenia febril em pacientes adultos tratados com quimioterapia citotóxica para malignidade (com exceção da leucemia mielóide crônica e síndromes mielodisplásicas).

União Europeia - português - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - imunossupressores - consulte a seção 4. 1 do resumo das características do produto no documento de informações do produto.

União Europeia - português - EMA (European Medicines Agency)

amgen europe b.v. - darbepoetin alfa - anemia; cancer; kidney failure, chronic - outras preparações antianemic - tratamento da anemia sintomática associada à insuficiência renal crônica (crf) em adultos e pacientes pediátricos. tratamento de anemia sintomática em adultos, o câncer de pacientes com não-mielóides a receber quimioterapia de neoplasias malignas.

União Europeia - português - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - leucemia linfoblástica com células precursoras - linfoma - agentes antineoplásicos - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

União Europeia - português - EMA (European Medicines Agency)

janssen-cilag international n.v.   - decitabina - leucemia, mieloide - agentes antineoplásicos - tratamento de pacientes adultos com leucemia mielóide aguda secundária (lea) recentemente diagnosticada, segundo a classificação da organização mundial da saúde (oms), que não são candidatos à quimioterapia de indução padrão.

União Europeia - português - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - mieloma múltiplo - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. em combinação com o bortezomib, talidomida e dexametasona para o tratamento de pacientes adultos diagnosticados com mieloma múltiplo que são elegíveis para transplante de células-tronco autólogas. em combinação com a lenalidomida e dexametasona, ou o bortezomib e dexametasona para o tratamento de pacientes adultos com mieloma múltiplo que tenham recebido pelo menos uma terapêutica prévia. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. como monoterapia para o tratamento de pacientes adultos com uma recaída e refratários mieloma múltiplo, cuja terapêutica prévia incluído um inibidor de proteassoma e um agente imunomodulador e que tenham demonstrado a progressão da doença no último terapia. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

União Europeia - português - EMA (European Medicines Agency)

janssen-cilag international n.v.    - cloridrato de rilpivirina - infecções por hiv - antivirais para uso sistêmico - o edurant, em combinação com outros medicamentos anti-retrovirais, é indicado para o tratamento da infecção pelo vírus da imunodeficiência humana tipo 1 (hiv-1) em pacientes com tratamento anti-retroviral com idade igual ou superior a 12 anos com carga viral ≤ 100,000 cópias de rna do hiv-1 / ml. como com outros medicamentos anti-retrovirais, genotypic do teste de resistência deve orientar o uso de edurant.