Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) Avrupa Birliği - Portekizce - EMA (European Medicines Agency)

lenalidomide krka (previously lenalidomide krka d.d. novo mesto)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - imunossupressores - multiple myelomalenalidomide krka 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 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 in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 e 5. follicular lymphomalenalidomide krka 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 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 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 in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 e 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Lenalidomide Krka d.d. Avrupa Birliği - Portekizce - EMA (European Medicines Agency)

lenalidomide krka d.d.

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - imunossupressores - multiple myelomalenalidomide krka d. 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. 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. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. follicular lymphomalenalidomide krka d. in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Darzalex Avrupa Birliği - Portekizce - EMA (European Medicines Agency)

darzalex

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.

Mozobil Avrupa Birliği - Portekizce - EMA (European Medicines Agency)

mozobil

sanofi b.v. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation; lymphoma - immunostimulants, - o mozobil é indicado em combinação com o fator estimulador de colônias de granulócitos para aumentar a mobilização de células estaminais hematopoiéticas para o sangue periférico para coleta e posterior transplante autólogo em pacientes com linfoma e mieloma múltiplo cujas células se mobilizam mal.

Revlimid Avrupa Birliği - Portekizce - EMA (European Medicines Agency)

revlimid

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).

Lenalidomide Accord Avrupa Birliği - Portekizce - EMA (European Medicines Agency)

lenalidomide accord

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).

Phelinun Avrupa Birliği - Portekizce - EMA (European Medicines Agency)

phelinun

adienne s.r.l. s.u. - melphalan hydrochloride - multiple myeloma; hodgkin disease; lymphoma, non-hodgkin; precursor cell lymphoblastic leukemia-lymphoma; leukemia, myeloid, acute; neuroblastoma; ovarian neoplasms; hematopoietic stem cell transplantation - agentes antineoplásicos - high-dose of phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (hodgkin, non-hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma. phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (ric) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-hsct) in malignant haematological diseases in adults. phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:myeloablative conditioning (mac) treatment in case of malignant haematological diseasesric treatment in case of non-malignant haematological diseases.

Lenalidomide Mylan Avrupa Birliği - Portekizce - EMA (European Medicines Agency)

lenalidomide mylan

mylan ireland limited - lenalidomida - mieloma múltiplo - imunossupressores - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. lenalidomide mylan 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 mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).