Unión Europea - español - EMA (European Medicines Agency)

fondazione telethon ets - autóloga cd34 + enriquecido fracción celular que contiene células de cd34 + transduced con vector retroviral que codifica para la secuencia de cdna humano de la adenosina desaminasa (ada) de las células humanas hematopoyéticas progenitoras (cd34 +) - inmunodeficiencia combinada severa - inmunoestimulantes, - strimvelis está indicado para el tratamiento de pacientes con la inmunodeficiencia combinada severa debido a la deficiencia de adenosina deaminasa (ada-scid), para quien no adecuado antígeno humano del leucocito (hla)-donante relacionado emparejado de la célula de vástago está disponible (véase la sección 4. 2 y sección 4.

Unión Europea - español - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - otras drogas del sistema nervioso - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Unión Europea - español - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - linfoma, célula del manto - agentes antineoplásicos - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

Perú - español - DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

trauma solutions sociedad anonima cerrada - trauma solutions s.a.c. -

Perú - español - DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

regen lab s.a. sucursal peru -

Perú - español - DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

regen lab s.a. sucursal peru -

Unión Europea - español - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - agentes antineoplásicos - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Unión Europea - español - EMA (European Medicines Agency)

dendreon uk ltd - autólogas células mononucleares de sangre periférica incluyendo un mínimo de 50 millones cd54 + células autólogas activadas con factor estimulante de colonias de granulocitos-macrófagos fosfatasa ácida prostática - neoplasmas prostáticos - otros inmunoestimulantes - provenge está indicado para el tratamiento del cáncer de próstata resistente a la castración metastásico (no visceral) asintomático o mínimamente sintomático en adultos varones en quienes la quimioterapia todavía no está clínicamente indicada.

Unión Europea - español - EMA (European Medicines Agency)

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - agentes antineoplásicos - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd). adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct). adcetris is indicated for the treatment of adult patients with relapsed or refractory cd30+ hodgkin lymphoma (hl):following asct, orfollowing at least two prior therapies when asct or multi-agent chemotherapy is not a treatment option. systemic anaplastic large cell lymphomaadcetris in combination with cyclophosphamide, doxorubicin and prednisone (chp) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (salcl). adcetris is indicated for the treatment of adult patients with relapsed or refractory salcl. cutaneous t cell lymphomaadcetris is indicated for the treatment of adult patients with cd30+ cutaneous t cell lymphoma (ctcl) after at least 1 prior systemic therapy.

Unión Europea - español - EMA (European Medicines Agency)

tigenix n.v. - células cartilaginosas autólogas caracterizadas expandidas ex vivo que expresan proteínas marcadoras específicas - enfermedades del cartílago - otras drogas para trastornos del sistema musculoesquelético - reparación de defectos solo sintomático cartílago del cóndilo femoral de la rodilla (grado iii o iv de sociedad internacional de reparación cartílago [icrs]) en adultos. concomitante asintomáticos lesiones del cartílago (icr grado i o ii) puede estar presente. demostración de la eficacia se basa en un ensayo aleatorizado y controlado para evaluar la eficacia de chondrocelect en pacientes con lesiones entre 1 y 5 cm2.