Ελλάδα - Ελληνικά - Εθνικός Οργανισμός Φαρμάκων

kyowa kirin holdings b.v., the netherlands bloemlaan 2, 2132np hoofddorp - mogamulizumab - c/s.sol.in (ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ) - 20mg/5ml (4mg/ml) - mogamulizumab 4mg - mogamulizumab

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - mogamulizumab - sezary syndrome; mycosis fungoides - Αντινεοπλασματικοί παράγοντες - poteligeo ενδείκνυται για τη θεραπεία ενηλίκων ασθενών με mycosis fungoides (mf) ή sézary σύνδρομο (ss) που έχουν λάβει τουλάχιστον μία προηγούμενη συστηματική θεραπεία.

Ελλάδα - Ελληνικά - Εθνικός Οργανισμός Φαρμάκων

alexion europe sas, france 103-105 rue anatole france, 92300 levallois-perret - ravulizumab - c/s.sol.in (ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ) - 300mg/30ml (10mg/ml) - ravulizumab 300mg - ravulizumab

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - Αιμοσφαιρινουρία, παροξυσμική - Επιλεκτικά ανοσοκατασταλτικά - 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.