Euroopa Liit - horvaadi - EMA (European Medicines Agency)

alexion europe sas - Экулизумаб - hemoglobinuria, paroxysmal - imunosupresivi - Солирис indiciran za odrasle i djecu, za liječenje:пароксизмальная noćni гемоглобинурия (apg). dokaza klinički učinak očituje se u bolesnika s гемолизом s klinički simptom(ova), ukazuje na visoke aktivnosti bolesti, bez obzira na priče transfuziju (vidi odjeljak 5. Атипичный гемолитико-уремический (agus). Солирис prikazan kod odraslih za liječenje:vatrostalne postati generalizirani миастенией gravis (ГГМ) u bolesnika s anti-ацетилхолиновому рецептору (АЧР) antitijela (vidi odjeljak 5. poremećaj neuromyelitis vidnog spektra (nmosd) kod pacijenata koji su anti-aquaporin-4 (aqp4) antitijela s recidivom tijekom bolesti.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selektivni imunosupresivi - 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.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - neoplazme dojki - antineoplastična sredstva - 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.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

pharmaswiss ceska republika s.r.o - pegaptanib - mokro makularna degeneracija - ophthalmologicals - macugen je indiciran za liječenje neovaskularne (mokre) dobne makularne degeneracije (amd).

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

dr. falk pharma gmbh - budesonide - ezofagealne bolesti - antidiarrheal sredstva, uzročnika crijevnih protuupalnih / antiinfective - jorrava je indicirana za liječenje eozinofilnog esophagitis (eoe) kod odraslih osoba (starijih od 18 godina).

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - naloxone hidroklorid dihidrat - poremećaji povezani s opioidom - svi ostali terapeutski proizvodi - nyxoid je namijenjen za neposrednu primjenu kao hitna terapija ili se sumnja predoziranje opioidima kao depresija dišnog sustava i/ili središnji živčani sustav u postavke ne-medicinskih i zdravstvenih. nyxoid is indicated in adults and adolescents aged 14 years and over. nyxoid is not a substitute for emergency medical care.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastim - neutropenija - Иммуностимуляторы, - za smanjenje trajanja нейтропении i frekvencije фебрильной нейтропении protiv kemoterapije.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastim - neutropenija - Иммуностимуляторы, - smanjenje duljine trajanja neutropenije i incidencije febrilne neutropenije u odraslih bolesnika liječenih citotoksičnom kemoterapijom zbog zloćudne bolesti (uz iznimku kronične mijeloične leukemije i mijelodisplastičnog sindroma).

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

galderma international - brimonidin tartrat - bolesti kože - ostali dermatološki pripravci - mirvaso je indiciran za simptomatsko liječenje eritema grudi rosacea kod odraslih pacijenata.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

biotest pharma gmbh - human hepatitis b immunoglobulin - immunization, passive; hepatitis b; liver transplantation - imuni serumi i homologna, - prevencija ponovne infekcije virusom hepatitisa b (hbv) u negativnim bolesnicima odraslih osoba hbsag i hbv-dna najmanje jedan tjedan nakon transplantacije jetre zbog hepatitisa b induciranog zatajivanja jetre. negativni status hbv-dna trebao bi se potvrditi u posljednja 3 mjeseca prije olt-a. bolesnici trebaju biti hbsag negativni prije početka liječenja. uz primjenu odgovarajućih agenata виростатического treba promatrati kao standard hepatitisa ponovno zaraze prevencija.