Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - trametinib - melanoma - antineoplastična sredstva - melanomatrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 i 5. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy (see section 5. adjuvant treatment of melanomatrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection. Немелкоклеточный rak pluća (НМРЛ)trametinib u kombinaciji s dabrafenib indiciran za liječenje odraslih bolesnika s preliminarnim non-mali raka pluća stanice s Браф mutacija v600 daleko .

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh - Метокси polietilen glikol-эпоэтин beta - anemia; kidney failure, chronic - antianemijski pripravci - treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adult patients (see section 5. treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (esa) after their haemoglobin level was stabilised with the previous esa (see section 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

life molecular imaging gmbh - florbetaben (18f) - radionuclide imaging; alzheimer disease - dijagnostički radiofarmaceutici - ovaj je lijek samo za dijagnostičku uporabu. neuraceq je радиофармацевтический lijek indiciran za pozitronska emisijska tomografija (pet) ct β amiloid neuritic gustoće plaka u mozgu odraslih pacijenata s kognitivnim oštećenjima, koje se vrednuju za bolesti Альцгеймераа (ad) i drugi razlozi kognitivnih oštećenja. neuraceq se mora koristiti u kombinaciji s kliničkom procjenom. negativan skeniranje ukazuje rijetki ili nema plakova, koji nije u skladu s dijagnozom pakao.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international nv - danmavir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Europska Unija - hrvatski - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ge healthcare as - flutemetamol (18f) - radionuclide imaging; alzheimer disease - dijagnostički radiofarmaceutici - ovaj je lijek samo za dijagnostičku uporabu. vizamyl je радиофармацевтический lijek indiciran za pozitronska emisijska tomografija (pet) ct β amiloid neuritic gustoće plaka u mozgu pacijenata s kognitivnim oštećenjima, koje su cijene kod alzheimerove bolesti (ba) i drugih razloga kognitivnih oštećenja. vizamil treba koristiti zajedno s kliničkom procjenom. negativan skeniranje ukazuje rijetki ili nema plakova, koji nije u skladu s dijagnozom pakao.

Europska Unija - hrvatski - EMA (European Medicines Agency)

csl behring gmbh - ljudski normalni imunoglobulin (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - imuni serumi i homologna, - hormonske terapije kod odraslih i djece i adolescenata (0-18 godina): primarne imunodeficijencije (pid) sindromi s kršenjem антителообразования;hypogammaglobulinaemia i rekurentne bakterijske infekcije u bolesnika s kroničnim лимфолейкозом, u kojima su preventivni antibiotici nisu pomogli;hypogammaglobulinaemia i рецидивирующих bakterijskih infekcija kod plato faza-nekoliko bolesnika, koji nisu uspjeli odgovoriti na пневмококковой cijepljenja;hypogammaglobulinaemia u bolesnika nakon аллогенной transplantacije hematopoetski organi-transplantacija matičnih stanica (ТГСК);urođeni aids-a s рецидивирующими bakterijske infekcije. Иммуномодуляция kod odraslih, i kod djece i adolescenata (0-18 godina): primarni imunološki trombocitopenija (ihs), u bolesnika s visokim rizikom od krvarenja ili prije operacije za podešavanje broja trombocita u krvi;sindrom Гийена-barre;bolest kawasaki;kronična upalna демиелинизирующая полинейропатия (ХВДП). samo je ograničeno iskustvo s korištenjem intravenski imunoglobulini, kod djece s ХВДП.

Europska Unija - hrvatski - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - anagrelide - trombocitemija, esencijalna - antineoplastična sredstva - xagrid je indiciran za smanjenje povišenih trombocita u rizičnih eterično-thrombocythaemia (et) bolesnika koji ne podnose da njihova trenutna terapija ili čiji povišenih trombocita ne umanjuju na prihvatljivu razinu njihove trenutne terapije. u grupu rizika patientan na rizik i određuje jedno ili više od sljedećeg:>60 godina;broj trombocita >1000 x 109/l;ili povijest događaja thrombohaemorrhagic .

Europska Unija - hrvatski - EMA (European Medicines Agency)

viatris healthcare limited - imikimod - keratosis; keratosis, actinic - antibiotici i kemoterapeutici za dermatološku uporabu - zyclara indicirana je za topikalno liječenje klinički tipične, ne-očigledni, sobe-hipertrofična, vidljiv ili opipljiv aktinička keratoza cijelo lice ili proćelav vlasišta u odraslih imunokompetentnih osoba kada su druge mogućnosti topikalna liječenje kontraindicirana ili manje prikladno.

Europska Unija - hrvatski - EMA (European Medicines Agency)

gmp-orphan sa - Триентин tetrahydrochloride - hepatolenticularna degeneracija - drugi gastrointestinalni trakt i metabolizam, lijekovi, - cuprior indiciran za liječenje bolesti wilsona kod odraslih, adolescenata i djece ≥ 5 godina s laktoza d-пеницилламин terapija.