Singapore - English - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - eculizumab - infusion, solution concentrate - 300 mg / vial - eculizumab 300 mg / vial

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alexion pharma uk ltd - eculizumab - solution for infusion - 10mg/1ml

Israel - English - Ministry of Health

alexion pharma israel ltd - eculizumab - concentrate for solution for infusion - eculizumab 10 mg/ml - eculizumab - eculizumab - soliris is indicated for the treatment of patients with: - paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history. eculizumab has not been studied in clinical trials in patients with pnh below 11 years of age.- atypical haemolytic uremic syndrome (ahus).soliris is indicated in adults for the treatment of: - refractory generalized myasthenia gravis (gmg) in patients who are anti-acetylcholine receptor (achr) antibody-positive.-neuromyelitis optica spectrum disorder (nmosd) in patients who are anti-aquaporin-4 (aqp4) antibody-positive with a relapsing course of the disease who have received prior therapy.

European Union - English - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinuria, paroxysmal - immunosuppressants - soliris is indicated in adults and children for the treatment of:paroxysmal nocturnal haemoglobinuria (pnh).evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1). atypical haemolytic uremic syndrome (ahus).soliris is indicated in adults for the treatment of:refractory generalized myasthenia gravis (gmg) in patients who are anti-acetylcholine receptor (achr) antibody-positive (see section 5.1).neuromyelitis optica spectrum disorder (nmosd) in patients who are anti-aquaporin-4 (aqp4) antibody-positive with a relapsing course of the disease.

European Union - English - EMA (European Medicines Agency)

samsung bioepis nl b.v. - eculizumab - hemoglobinuria, paroxysmal - immunosuppressants - epysqli is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh).evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

European Union - English - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - hemoglobinuria, paroxysmal - immunosuppressants - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1).

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - eculizumab 300mg;  ;  ;   - solution for infusion - 300mg/30ml - active: eculizumab 300mg       excipient: dibasic sodium phosphate heptahydrate monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection - soliris® is indicated for the treatment of patients with paroxysmal nocturnal haemoglobinuria (pnh)to reduce haemolysis.