Union européenne - français - EMA (European Medicines Agency)

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - immunosuppresseurs - uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (nmosd) who are anti-aquaporin 4 immunoglobulin g (aqp4-igg) seropositive (see section 5.

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

horizon therapeutics switzerland gmbh - inebilizumabum - solution à diluer pour perfusion - inebilizumabum 100 mg, histidinum, histidini hydrochloridum monohydricum, natrii chloridum, trehalosum dihydricum, polysorbatum 80, aqua ad iniectabile, ad solutionem pro 10 ml corresp., natrium 16.1 mg. - behandlung von erwachsenen patienten mit neuromyelitis-optica-spektrum-erkrankungen (nmosd), die anti-aquaporin-4-immunglobulin g(aqp4-igg)-seropositiv sind - biotechnologika

Union européenne - français - EMA (European Medicines Agency)

elan pharma international ltd. - natalizumab - maladie de crohn - les immunostimulants, - traitement de modérément à sévèrement active de la maladie de crohn pour la réduction des signes et des symptômes, et l'induction et l'entretien de réponse soutenue et de la rémission chez les patients qui n'ont pas répondu malgré une pleine et adéquate cours du traitement avec un corticostéroïde et d'un immunosuppresseur; ou une intolérance ou de contre-indications médicales à ces thérapies.

Union européenne - français - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosuppresseurs - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab 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. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

roche pharma (schweiz) ag - tocilizumabum - solution injectable voie sous-cutanée - tocilizumabum 162 mg, polysorbatum 80, arginini hydrochloridum, methioninum, histidinum, histidini hydrochloridum monohydricum, aqua ad iniectabile q.s. ad solutionem pro 0.9 ml. - la polyarthrite rhumatoïde, l'artérite à cellules géantes, arthrite juvénile idiopathique polyarticulaire, juvénile systémique idiopatische l'arthrite - biotechnologika

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

roche pharma (schweiz) ag - tocilizumabum - solution injectable en stylo prérempli voie sous-cutanée - tocilizumabum 162 mg, polysorbatum 80, arginini hydrochloridum, methioninum, histidinum, histidini hydrochloridum monohydricum, aqua ad iniectabile q.s. ad solutionem pro 0.9 ml. - la polyarthrite rhumatoïde, l'artérite à cellules géantes, arthrite juvénile idiopathique polyarticulaire, l'arthrite idiopathique juvénile systémique - biotechnologika

Suisse - français - Swissmedic (Swiss Agency for Therapeutic Products)

biogen switzerland ag - natalizumabum - solution à diluer pour perfusion - natalizumabum 300 mg, natrii dihydrogenophosphas monohydricus, dinatrii phosphas heptahydricus, natrii chloridum, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 15 ml corresp. natrium 52 mg. - multiple sklerose - biotechnologika

Union européenne - français - EMA (European Medicines Agency)

theratechnologies europe limited - ibalizumab - infections au vih - antiviraux à usage systémique - trogarzo, en association avec d'autres antirétroviraux(s), est indiqué pour le traitement des adultes infectés par la tuberculose multi résistante à l'infection vih-1 pour lesquels il n'est pas possible de construire un oppresseur antiviral régime.

Union européenne - français - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - sclérose en plaque - immunosuppresseurs sélectifs - 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 et 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.

Union européenne - français - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosuppresseurs - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease 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 et 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.