Europska Unija - hrvatski - EMA (European Medicines Agency)

intervet international bv - inaktivirani cijeli virus antigena ptičje gripe tipa h5n2 (vrsta a / patka / potsdam / 1402/86) - imunološki za aves - piletina - za aktivnu imunizaciju pilića protiv ptičje gripe tipa a, podtip h5. učinkovitost je ocijenjena na temelju preliminarnih rezultata u pilićima. smanjenje kliničkih znakova, smrtnosti i izolacije virusa nakon zaraze su pokazala tri tjedna nakon cijepljenja. očekuje se da će se serumska antitijela ustrajati barem 12 mjeseci nakon davanja dviju doza cjepiva.

Europska Unija - hrvatski - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticase - giht - antigadni pripravci - krystexxa je indiciran za liječenje teškog oslabiti kronične tophaceous gihta u odraslih bolesnika koji može imati erozivni zajednički angažman i koji nisu uspjeli normalizirati serumske mokraćne kiseline s ksantin oksidaza inhibitori maksimalno medicinski odgovarajuće doze ili kojima ovi lijekovi su kontraindicirani.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi b.v. - sevelamer karbonat - hyperphosphatemia; renal dialysis - svi ostali terapeutski proizvodi - renvela je indicirana za kontrolu hiperfosfatemije kod odraslih osoba koje primaju hemodijalizu ili peritonealnu dijalizu. renvela također je prikazano za kontrolu hyperphosphataemia u odraslih bolesnika s kroničnom bolešću bubrega bez dijalizu s fosfora u serumu ≥ 1. 78 mmol/l. renvela treba koristiti u okviru nekoliko terapijskih pristupa koji se mogu uključiti dodataka kalcija, 1,25-дигидрокси vitamin d3 ili jedan od njegovih analoga za praćenje razvoja bolesti bubrega канальцах .

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi b.v. - sevelamer karbonat - hyperphosphatemia; renal dialysis - svi ostali terapeutski proizvodi - Севеламера kalcijev winthrop je dizajniran za kontrolu hyperphosphataemia kod odraslih pacijenata koji primaju гемодиализ ili перитонеальный dijaliza. Севеламера kalcijev winthrop također je prikazano za kontrolu hyperphosphataemia u odraslih bolesnika s kroničnom bolešću bubrega bez dijalizu s fosfora u serumu > 1. 78 mmol / l. Севеламера kalcijev winthrop treba koristiti u okviru nekoliko terapijskih pristupa koji se mogu uključiti dodataka kalcija, 1,25-дигидрокси-vitamin d3 ili jedan od njegovih analoga za praćenje razvoja bolesti bubrega канальцах .

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi b.v. - tirotropin alfa - neoplazme štitnjače - prednje hipofize hormoni i analozi, hipofize i гипоталамические hormoni i analozi - thyrogen is indicated for use with serum thyroglobulin (tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (thst). low risk patients with well-differentiated thyroid carcinoma who have undetectable serum tg levels on thst and no rh (recombinant human) tsh-stimulated increase of tg levels may be followed-up by assaying rh tsh-stimulated tg levels. thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mci (1. 1 gbq) to 100 mci (3. 7 gbq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi b.v. - sevelamer - renal dialysis; hyperphosphatemia - svi ostali terapeutski proizvodi - renagel is indicated for the control of hyperphosphataemia in adult patients receiving  haemodialysis or peritoneal dialysis. renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy vitamin d3 or one of its analogues to control the development of renal bone disease.

Europska Unija - hrvatski - EMA (European Medicines Agency)

takeda pharma a/s - darvadstrocel - Прямокишечный fistula - imunosupresivi - alofisel indiciran za liječenje najtežih параректальных свищей u odraslih bolesnika s aktivnom/umjereno aktivan lumena crohnova bolest, fistula, kada su pokazala neadekvatan odgovor na barem jednog običnog ili biološka terapija. alofisel treba koristiti nakon klima свищей.

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

biognost d.o.o., zagreb - priprema alikvota kapi za oči iz autolognih krvnih komponenti krvnog seruma, plazme bogate trombocitima (prp), koncentrata tromb

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.

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

jasika d.o.o. za trgovinu i zastupanje remetinačka cesta 115 10000 zagreb -