Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - imunosupresivi - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Europska Unija - hrvatski - EMA (European Medicines Agency)

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - imunosupresivi - uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (nmosd) who are anti-aquaporin 4 immunoglobulin g (aqp4-igg) seropositive (see section 5.

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

shimadzu d.o.o, zagreb - in vitro dijagnostika, mjerenje i identifikaciju različitih spojeva i molekula na bazi omjera njihove mase i naboja

Europska Unija - hrvatski - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. pogledajte odjeljke 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

johnson & johnson s.e. d.o.o., oreškovićeva 6h, zagreb, hrvatska - ibuprofenum, pseudoephedrinum - filmom obložena tableta - 200 mg + 30 mg - urbroj: jedna filmom obložena tableta sadrži 200 mg ibuprofena i 30 mg pseudoefedrinklorida

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

double-e pharma ltd., 7th floor, hume house, ballsbridge, dublin, irska - moksifloksacinklorid - filmom obložena tableta - 400 mg - urbroj: svaka filmom obložena tableta sadrži 400 mg moksifloksacina (u obliku klorida)

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

bayer d.o.o., radnička cesta 80, zagreb, hrvatska - gadobutrol - otopina za injekciju u napunjenoj štrcaljki - 1,0 mmol/ml - urbroj: 1 ml otopine za injekciju sadrži 604,72 mg gadobutrola (što odgovara 1,0 mmol gadobutrola, odnosno 157,25 mg gadolinija)

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

bracco imaging s.p.a., via egidio folli 50, milano, italija - gadoteridol - otopina za injekciju u napunjenoj štrcaljki - 0,5 mmol/ml - urbroj: 1 ml otopine za injekciju sadrži 279,3 mg gadoteridola (što odgovara 0,5 mmol/ml gadoteridola)

Europska Unija - hrvatski - EMA (European Medicines Agency)

infai, institut für biomedizinische analytik nmr-imaging gmbh - urea (13c) - breath tests; helicobacter infections - dijagnostička sredstva - Хеликобактер test infai može se koristiti za прижизненного dijagnoze гастродуоденальной zone helicobacter pylori infekcija:odrasli;tinejdžeri koji su, vjerojatno, imaju peptičkog ulkusa. Хеликобактер test infai za djecu u dobi od tri do 11 godina, može se koristiti za прижизненного dijagnoze gastrduodenal helicobacter pylori infekcija:za procjenu uspješnosti эрадикационной terapije, ili kada neinvazivni testovi ne mogu biti ispunjeni, ili kada postoji дискордантные rezultati koji proizlaze iz invazivnih testova. ovaj je lijek samo za dijagnostičku uporabu.