Ultomiris Unia Europejska - polski - EMA (European Medicines Agency)

ultomiris

alexion europe sas - ravulizumab - hemoglobinuria, paroksysmal - selektywne leki immunosupresyjne - 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.

Rhokiinsa Unia Europejska - polski - EMA (European Medicines Agency)

rhokiinsa

santen oy - netarsudil - glaucoma, open-angle; ocular hypertension - okulistyka - obniżenie podwyższonego ciśnienia wewnątrzgałkowego (iop) u dorosłych pacjentów z pierwotną jaskrą otwartego kąta lub nadciśnienie oczne.

Lumeblue (previously known as Methylthioninium chloride Cosmo) Unia Europejska - polski - EMA (European Medicines Agency)

lumeblue (previously known as methylthioninium chloride cosmo)

alfasigma s.p.a. - chlorek metylotioniny - colorectal neoplasms; colonoscopy - other diagnostic agents - lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.