Unia Europejska - słowacki - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinúria, paroxysmálna - selektívne imunosupresíva - 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.

Unia Europejska - słowacki - EMA (European Medicines Agency)

gennisium pharma - kofeín citrát - apnoe - psychoanaleptics, - liečba primárnych apnoea predčasnej novorodencov.

Unia Europejska - słowacki - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - neoplazmy prsníkov - antineoplastické činidlá - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Unia Europejska - słowacki - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - quizartinib dihydrochloride - leukémia, myeloid - antineoplastic agents, protein kinase inhibitors - vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (aml) that is flt3-itd positive.

Unia Europejska - słowacki - EMA (European Medicines Agency)

bial - portela cª, s.a. - opicapone - parkinsonova choroba - antiparkinsonické lieky - ongentys je indikovaný ako prídavná terapia na prípravky levodopy / dopa inhibítory dekarboxylázy (ddci) u dospelých pacientov s parkinsonovou chorobou a motorickými fluktuáciami na konci účinku dávky, ktorí nemôžu byť stabilizovaný tie kombinácie. ongentys je indikovaný ako prídavná terapia na prípravky levodopy / dopa inhibítory dekarboxylázy (ddci) u dospelých pacientov s parkinsonovou chorobou a motorickými fluktuáciami na konci účinku dávky, ktorí nemôžu byť stabilizovaný tie kombinácie.

Unia Europejska - słowacki - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - naloxonu hydrochlorid disodný - poruchy súvisiace s opiátmi - všetky ostatné terapeutické produkty - nyxoid je určený na okamžité podanie ako núdzová terapia pre alebo suspektná predávkovanie opiátmi, ako sa prejavuje depresiou dýchania a/alebo centrálny nervový systém v nastavení non-lekárske a zdravotnícke. nyxoid is indicated in adults and adolescents aged 14 years and over. nyxoid is not a substitute for emergency medical care.

Unia Europejska - słowacki - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastím - neutropénia - immunostimulants, - znížiť trvanie neutropenia a výskyt horúčkovitým neutropenia chemoterapie.

Unia Europejska - słowacki - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastím - neutropénia - immunostimulants, - zníženie trvania neutropénie a výskytu febrilnej neutropénie u dospelých pacientov liečených cytotoxickou chemoterapiou kvôli malígnemu (s výnimkou chronickej myeloidnej leukémie a myelodysplastických syndrómov).

Unia Europejska - słowacki - EMA (European Medicines Agency)

norgine b.v. - železitý maltol - anémia, nedostatok železa - antianemické prípravky - feraccru je indikovaný u dospelých na liečbu nedostatku železa.

Unia Europejska - słowacki - EMA (European Medicines Agency)

biotest pharma gmbh - imunoglobulín proti ľudskej hepatitíde b - immunization, passive; hepatitis b; liver transplantation - imunitný séra a imunoglobulíny, - prevencia infekcii vírusom hepatitídy b (hbv) opätovné hbsag a hbv-dna negatívne udospelých pacientov najmenej jeden týždeň po transplantácii pečene hepatitídy b indukovanej zlyhania pečene. negatívny stav hbv-dna by sa mal potvrdiť v priebehu posledných 3 mesiacov pred olt. pacienti majú byť pred začiatkom liečby negatívnymi hbsag. súbežné použitie primeraného virostatic agenti by mali byť považované za štandardné hepatitídy b re-profylaxia infekcie.