Den Europæiske Union - dansk - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - multipel sclerose - selektive immunosuppressiva - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 og 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

pfizer europe ma eeig - tofacitinib - arthritis, reumatoid - immunosuppressiva - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 og 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

bayer ag - radium (223ra) dichloride - prostatiske neoplasmer - terapeutiske radioaktive lægemidler - xofigo er indiceret til behandling af voksne med kastreringsresistent prostatacancer, symptomatiske knoglemetastaser og ingen kendte viscerale metastaser.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - burosumab - hypophosphatemia, familial; hypophosphatemic rickets, x-linked dominant; osteomalacia - narkotika til behandling af knoglesygdomme - crysvita is indicated for the treatment of x-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. crysvita is indicated for the treatment of fgf23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

ceva santé animale - toltrazuril, jern (iii) ion - toltrazuril, kombinationer - grise (grise) - for samtidig med forebyggelse af jernmangel anæmi og forebyggelse af kliniske tegn på coccidiosis (diarré), samt reduktion i oocyst udskillelse, i smågrise i bedrifter med en bekræftet historien af coccidiosis, der er forårsaget af cystoisospora suis.

Den Europæiske Union - dansk - 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - carcinom, squamous cell - antineoplastiske midler - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

dechra regulatory b.v. - mirtazapin - psychoanaleptics, antidepressants in combination with psycholeptics - katte - for kropsvægt gevinst i katte, der oplever dårlig appetit og vægttab som følge af kroniske lidelser.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

otsuka novel products gmbh - delamanid - tuberkulose, multidrugt-resistent - antimyco-bakterielle midler - deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (mdr-tb) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4. 2, 4. 4 og 5. det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..

Den Europæiske Union - dansk - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - eprinomectin, fipronil, praziquantel, (s) -methopren - antiparasitic products, insecticides and repellents, avermectins, eprinomectin, combinations, - katte - for katte med eller i fare fra blandede angreb af cestoder, nematoder og ektoparasitter. det veterinære lægemidler produkt er udelukkende angivet, når alle tre grupper er målrettet på samme tid. ectoparasitestreatment og forebyggelse af angreb af lopper (ctenocephalides felis). afskaffelse af lopper inden for 24 timer. Én behandling forebygger yderligere angreb i mindst en måned. forebyggelse af miljø-loppe forurening ved at hæmme udviklingen af loppe umodne stadier (æg, larver og pupper) for over en måned. produktet kan bruges som en del af en behandlingsstrategi til bekæmpelse af loppe allergi dermatitis (fad). behandling og forebyggelse af angreb af skovflåter (ixodes ricinus). fjernelse af flåter inden for 48 timer. Én behandling forebygger yderligere angreb i op til 3 uger. behandling af notoedric sukkerærter (notoedres cati). cestodestreatment for infestationer med bændelorm (dipylidium caninum, taenia taeniaeformis, echinococcus multilocularis, joyeuxiella pasqualei (voksen), og joyeuxiella fuhrmanni (voksen)). nematodestreatment af angreb med mave-nematoder (l3, l4-larver og voksne i toxocara cati, voksne af toxascaris leonina, l4-larver og voksne i ancylostoma tubaeforme og ancylostoma ceylanicum, og voksne i ancylostoma brazilienze). behandling af angreb med feline lungworms (l3 larver, l4-larver og voksne i aelurostrongylus abstrusus, l4-larver og voksne i troglostrongylus brevior). behandling af angreb med vesical orme (capillaria plica). forebyggelse af sygdom hjerteorm (dirofilaria immitis larver) for en måned.