⚠ EN DIRECT — European Consumer Safety Watch 💊 Médicaments: 18 au cours des 7 derniers jours 🍎 Alimentation: 180 au cours des 7 derniers jours 🧸 Produits: 48 au cours des 7 derniers jours 🟢 Surveillance: EMA · RASFF · NVWA · FAGG · FAVV · EFSA · Safety Gate ⏱ Dernière récupération: il y a 28 minutes ⚠ EN DIRECT — European Consumer Safety Watch 💊 Médicaments: 18 au cours des 7 derniers jours 🍎 Alimentation: 180 au cours des 7 derniers jours 🧸 Produits: 48 au cours des 7 derniers jours 🟢 Surveillance: EMA · RASFF · NVWA · FAGG · FAVV · EFSA · Safety Gate ⏱ Dernière récupération: il y a 28 minutes
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Ultomiris

ravulizumab
Hémoglobinurie paroxystique
✅ Autorisé
Aucune alerte active
Ce médicament ne fait l'objet ni de pénuries en cours, ni de lettres de sécurité, ni de rappels.

À quoi ça sert

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.

⚠️ Sécurité des patients

No

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