Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

recordati rare diseases immeuble "le wilson", 70 avenue du general de gaulle 92800 puteaux (frankrijk) - humaan hemine 25 mg/ml - concentraat voor oplossing voor infusie - arginine, (l-) ; ethanol 96 % 100 mg/ml ; propyleenglycol (e 1520) 400 mg/ml ; stikstof (head space) (e 941) ; water voor injectie, - hemin

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

orion corporation orionintie 1 sf-02200 espoo (finland) - budesonide 160 µg/dosis ; formoterolfumaraat 2-water 4,5 µg/dosis samenstelling overeenkomend met ; formoterol 3,7 µg/dosis - inhalatiepoeder - lactose 1-water, - formoterol and budesonide

Kesatuan Eropah - Belanda - EMA (European Medicines Agency)

accord healthcare s.l.u. - lacosamide - epilepsie - van anti-epileptica, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. •         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Kesatuan Eropah - Belanda - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - naloxon hydrochloride dihydraat - opioïde-gerelateerde stoornissen - alle andere therapeutische producten - nyxoid is bedoeld voor onmiddellijke toediening als noodbehandeling voor bekende of vermoede opioïdoverdosis, zoals blijkt uit depressie van het ademhalingsstelsel en / of het centrale zenuwstelsel in zowel niet-medische als gezondheidszorgomgevingen. nyxoid is indicated in adults and adolescents aged 14 years and over. nyxoid is not a substitute for emergency medical care.

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

orion corporation - hydrochloorthiazide - tablet - lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; siliciumdioxide (e 551), - hydrochlorothiazide

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

orion corporation - hydrochloorthiazide - tablet - lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; siliciumdioxide (e 551), - hydrochlorothiazide

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

orion corporation orionintie 1 sf-02200 espoo (finland) - fluticasonpropionaat 500 µg/dosis ; salmeterolxinafoaat 73 µg/dosis samenstelling overeenkomend met ; salmeterol 50 µg/dosis - inhalatiepoeder - lactose 1-water, - salmeterol and fluticasone

Kesatuan Eropah - Belanda - EMA (European Medicines Agency)

amryt pharmaceuticals dac - metreleptin - lipodystrofie, familiaire gedeeltelijke - andere maagdarmkanaal en metabolisme producten, - myalepta is geïndiceerd als een aanvulling op dieet als vervangende therapie voor de behandeling van de complicaties van leptin tekort in lipodystrofie (ld) patiënten:met bevestigde aangeboren gegeneraliseerde ld (berardinelli-seip syndroom) of verworven gegeneraliseerde ld (lawrence syndroom) bij volwassenen en kinderen van 2 jaar oud en abovewith bevestigd familiaire gedeeltelijke ld of verworven gedeeltelijke ld (barraquer-simons syndroom), bij volwassenen en kinderen van 12 jaar en ouder voor wie standaard behandelingen hebben gefaald om voldoende metabole controle.

Kesatuan Eropah - Belanda - EMA (European Medicines Agency)

orion corporation - ropinirole hydrochloride - dopaminerge agenten, dopamine-agonisten - honden - inductie van braken bij honden.

Kesatuan Eropah - Belanda - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinurie, paroxysmale - selectieve immunosuppressiva - 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.