idefirix
hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - inmunosupresores - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.
apixaban accord
accord healthcare s.l.u. - apixaban - venous thromboembolism; stroke; arthroplasty - agentes antitrombóticos - prevention of venous thromboembolic events (vte) in adult patients who have undergone elective hip or knee replacement surgery. prevención del ictus y la embolia sistémica en pacientes adultos con fibrilación auricular no valvular no valvular (fanv), con uno o más factores de riesgo, tales como antecedente de accidente cerebrovascular o ataque isquémico transitorio (tia); edad ≥ 75 años; hipertensión; diabetes mellitus; insuficiencia cardíaca sintomática (clase nyha ≥ ii). tratamiento de la trombosis venosa profunda (tvp) y embolia pulmonar (pe), y la prevención de la recurrencia de la tvp y de la ep en adultos (ver sección 4. 4 para hemodinámicamente inestable pe pacientes). prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (nvaf), with one or more risk factors, such as prior stroke or transient ischaemic attack (tia); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (nyha class ≥ ii). tratamiento de la trombosis venosa profunda (tvp) y embolia pulmonar (pe), y la prevención de la recurrencia de la tvp y de la ep en adultos (ver sección 4. 4 para hemodinámicamente inestable pe pacientes).
tecartus
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).
roclanda
santen oy - latanoprost, netarsudil mesilate - glaucoma, open-angle; ocular hypertension - oftalmológicos - roclanda is indicated for the reduction of elevated intraocular pressure (iop) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient iop reduction.
tukysa
seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - agentes antineoplásicos - tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with her2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑her2 treatment regimens.
kesimpta
novartis ireland ltd - ofatumumab - la esclerosis múltiple remitente-recurrente - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.
enspryng
roche registration gmbh - satralizumab - neuromyelitis optica - inmunosupresores - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.
ponvory
janssen-cilag international n.v. - ponesimod - la esclerosis múltiple remitente-recurrente - inmunosupresores - ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.
qinlock
deciphera pharmaceuticals (netherlands) b.v. - ripretinib - tumores del estroma gastrointestinal - agentes antineoplásicos - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.
ngenla
pfizer europe ma eeig - somatrogon - growth and development - de la hipÓfisis y del hipotÁlamo hormonas y anÁlogos - indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.