Unión Europea - español - EMA (European Medicines Agency)

zoetis belgium s.a. - canine parainfluenza virus, leptospira and rabies virus. - immunologicals para los miembros de la familia canidae, vivas e inactivadas vacunas virales y bacterianas - perros - la inmunización activa de perros a partir de seis semanas de edad, para prevenir los signos clínicos y reducir la excreción viral causa por el virus de la parainfluenza canina, para prevenir los signos clínicos de la infección y excreción urinaria causa por serovares de leptospira bratislava, canicola, grippotyphosa y icterohaemorrhagiae y para prevenir la mortalidad, signos clínicos y causar infección por el virus de la rabia.

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)

pfizer europe ma eeig  - voxelotor - anemia; anemia, hemolytic; anemia, sickle cell - other hematological agents - oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (scd) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.

Unión Europea - español - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - metabolismo de aminoácidos, errores congénitos - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.

Unión Europea - español - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - trasplante autólogo de células cd34+ población enriquecida que contiene células madre hematopoyéticas células transducidas con lentiglobin bb305 codificación de vectores lentivirales la beta-un-t87q-gen de la globina - beta-talasemia - other hematological agents - zynteglo está indicado para el tratamiento de los pacientes de 12 años y más de edad dependientes de transfusión β talasemia (tdt) que no tienen un β0/β0 genotipo, para quien células madre hematopoyéticas (hsc), el trasplante es apropiado, pero un antígeno leucocitario humano (hla)-los relacionados con hsc donante no está disponible.

Unión Europea - español - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - otras drogas del sistema nervioso - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Unión Europea - español - EMA (European Medicines Agency)

recordati netherlands b.v. - siltuximab - hiperplasia del ganglio linfático gigante - inmunosupresores - sylvant está indicado para el tratamiento de pacientes adultos con enfermedad de castleman multicéntrica (mcd que son virus de inmunodeficiencia humana (vih) negativo y humano herpesvirus-8 (humano hhv-8) negativo.

Unión Europea - español - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - esclerosis múltiple - inmunosupresores selectivos - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 y 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Unión Europea - español - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - tumores del estroma gastrointestinal - otros agentes antineoplásicos, inhibidores de la proteína quinasa - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

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.