Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - immunosuppressiva - 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.

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - multiple sclerose, relapsing-remitting - immunosuppressiva - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - multiple sclerose, relapsing-remitting - immunosuppressiva - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 en 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.

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - lupus erythematosus, systemisch - immunosuppressiva - saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (sle), despite standard therapy.

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

laboratorios lesvi s.l. - dimethylfumaraat - multiple sclerose, relapsing-remitting - immunosuppressiva - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - immunosuppressiva - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multiple sclerose, relapsing-remitting - immunosuppressiva - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosuppressiva - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

ucb pharma sa - certolizumab pegol - ziekte van crohn - immunosuppressiva - cimzia, in combination with methotrexate (mtx), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (ra) in adult patients when the response to disease-modifying antirheumatic drugs (dmard) including methotrexate, has been inadequate. cimzia kan worden gegeven als monotherapie in geval van intolerantie voor methotrexaat of wanneer voortgezette behandeling met methotrexaat als ongepast. cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.

Nīderlande - holandiešu - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

accord healthcare b.v. winthontlaan 200 3526 kv utrecht - methotrexaat 100 mg/ml - concentraat voor oplossing voor infusie - natriumhydroxide (e 524) ; stikstof (head space) (e 941) ; water voor injectie, - methotrexate