Европска Унија - Дански - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuri, paroxysmal - selektive immunosuppressiva - 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.

Европска Унија - Дански - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - avatrombopag maleate - trombocytopeni - antihemorrhagics - doptelet er indiceret til behandling af svær trombocytopeni hos voksne patienter med kronisk leversygdom, der er planlagt til at blive en invasiv procedure. doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e. kortikosteroider, immunglobuliner).

Европска Унија - Дански - EMA (European Medicines Agency)

theratechnologies europe limited - ibalizumab - hiv infektioner - antivirale midler til systemisk anvendelse - trogarzo, i kombination med andre antiretrovirale(s), er indiceret til behandling af voksne, der er smittet med multidrug resistente hiv-1 infektion, for hvem det ellers ikke er muligt at konstruere et undertrykkende regime antiviral.

Европска Унија - Дански - EMA (European Medicines Agency)

sanofi winthrop industrie - isatuximab - multipelt myelom - antineoplastiske midler - sarclisa is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (mm) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (pi) and have demonstrated disease progression on the last therapy. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.

Европска Унија - Дански - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - immunosuppressiva - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Европска Унија - Дански - EMA (European Medicines Agency)

serb sa - amifampridine phosphate - lambert-eaton myasthenic syndrome; paraneoplastic syndromes, nervous system; nervous system neoplasms; paraneoplastic syndromes; nervous system diseases; autoimmune diseases of the nervous system; neurodegenerative diseases; neuromuscular diseases; neuromuscular junction diseases; immune system diseases; autoimmune diseases; autoimmune diseases of the nervous system; cancer; neoplasms - andre narkotika stoffer - symptomatisk behandling af lambert-eaton myasthenisk syndrom (lems) hos voksne.

Европска Унија - Дански - EMA (European Medicines Agency)

astrazeneca ab - tezepelumab - astma - medicin for obstruktiv sygdomme, - tezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Европска Унија - Дански - EMA (European Medicines Agency)

roche registration gmbh - faricimab - wet macular degeneration; macular edema; diabetes complications - oftalmologiske - vabysmo is indicated for the treatment of adult patients with:neovascular (wet) age-related macular degeneration (namd),visual impairment due to diabetic macular oedema (dme).

Европска Унија - Дански - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - spesolimab - psoriasis - immunosuppressiva - spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (gpp) as monotherapy.

Европска Унија - Дански - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - antineoplastiske midler - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc). imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.