Europäische Union - Deutsch - EMA (European Medicines Agency)

rad neurim pharmaceuticals eec sarl - melatonin - sleep initiation and maintenance disorders; autistic disorder - psycholeptika - slenyto ist indiziert für die behandlung von schlafstörungen bei kindern und jugendlichen im alter von 2-18 mit autismus-spektrum-störung (asd) und / oder smith-magenis-syndrom, wo die schlaf-hygiene maßnahmen unzureichend sind,.

Europäische Union - Deutsch - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hämoglobinurie, paroxysmal - selektive immunsuppressiva - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Europäische Union - Deutsch - EMA (European Medicines Agency)

accord healthcare s.l.u. - dexmedetomidin - prämedikation - psycholeptika - zur sedierung von erwachsenen-icu (intensive care unit) patienten, die eine sedierung ebene nicht tiefer als erregung in reaktion auf verbale stimulation (entsprechend der richmond agitation-sedation scale (rass) 0 bis -3). zur sedierung von nicht-intubierten erwachsenen patienten vor und/oder während der diagnostischen oder chirurgischen verfahren erfordern sedierung, ich. prozedurale/wach sedierung.

Europäische Union - Deutsch - EMA (European Medicines Agency)

paion deutschland gmbh - remimazolam besilate - bewusste sedierung - psycholeptika - remimazolam is indicated in adults for procedural sedation. remimazolam 50 mg is indicated in adults for intravenous induction and maintenance of general anaesthesia.

Europäische Union - Deutsch - EMA (European Medicines Agency)

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

Europäische Union - Deutsch - EMA (European Medicines Agency)

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - immunsuppressiva - 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.

Österreich - Deutsch - AGES (Agentur für Gesundheit und Ernährungssicherheit)

gsk-gebro consumer healthcare gmbh - chlorhexidindigluconat - chlorhexidin

Österreich - Deutsch - AGES (Agentur für Gesundheit und Ernährungssicherheit)

gsk-gebro consumer healthcare gmbh - chlorhexidindigluconat - chlorhexidin

Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

cheplapharm arzneimittel gmbh (8023489) - midazolamhydrochlorid - injektionslösung - teil 1 - injektionslösung; midazolamhydrochlorid (23124) 55,6 milligramm

Österreich - Deutsch - AGES (Agentur für Gesundheit und Ernährungssicherheit)

gsk-gebro consumer healthcare gmbh - chlorhexidin digluconat -