⚠ LIVE — European Consumer Safety Watch 💊 Medicinsk kanal: 18 I løbet af de seneste 7 dage 🍎 Fødevarer: 180 I løbet af de seneste 7 dage 🧸 Kanalens produkter: 48 I løbet af de seneste 7 dage 🟢 Overvågning: EMA · RASFF · NVWA · FAGG · FAVV · EFSA · Safety Gate ⏱ Seneste hentning: for 27 minutter siden ⚠ LIVE — European Consumer Safety Watch 💊 Medicinsk kanal: 18 I løbet af de seneste 7 dage 🍎 Fødevarer: 180 I løbet af de seneste 7 dage 🧸 Kanalens produkter: 48 I løbet af de seneste 7 dage 🟢 Overvågning: EMA · RASFF · NVWA · FAGG · FAVV · EFSA · Safety Gate ⏱ Seneste hentning: for 27 minutter siden
🛡️ EUSW
🇩🇰
💊

Ultomiris

ravulizumab
Hæmoglobinuri, paroksystisk
✅ Autoriseret
Ingen aktive alarmer
Denne medicin har ingen igangværende mangel, sikkerhedsbreve eller tilbagekaldelser.

Hvad det bruges til

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 5.1). 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 5.1). 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 5.1). 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.

⚠️ Patient sikkerhed

No

⚠️ Vi sammenfatter officielle meddelelser. Vi giver ikke lægelig rådgivning. Ved lægelige eller juridiske beslutninger skal du konsultere den relevante myndighed og en kvalificeret fagperson.