Lytgobi Euroopan unioni - kroatia - EMA (European Medicines Agency)

lytgobi

taiho pharma netherlands b.v. - futibatinib - cholangiocarcinoma - agenti imaju antikancerogena - lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Darunavir Mylan Euroopan unioni - kroatia - EMA (European Medicines Agency)

darunavir mylan

mylan pharmaceuticals limited - danmavir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - darunavir, 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 (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):za liječenje hiv-1 infekcije u антиретровирусной terapije (art)-iskusni odrasli pacijenti, uključujući i one koji su bili jako prethodno obrađene. za liječenje hiv-1 infekcije u pedijatrijska bolesnika u dobi od 3 godina i najmanje 15 kg tjelesne težine. odlučivši započeti liječenje s дарунавир uvedeni zajedno s malom dozom ritonavir, pažljivo razmatranje treba posvetiti povijesti liječenje pacijenta i prirode mutacije povezane s različitim posrednika. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 i 5. Дарунавир uvedeni zajedno s malom dozom ritonavir je navedeno u kombinaciji s drugim антиретровирусными lijekovima za liječenje pacijenata s virusom humane imunodeficijencije (hiv-1 infekcije) .  darunavir 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) (see section 4.  darunavir mylan 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 (see section 4.  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. odlučivši započeti liječenje s дарунавир u takvim art-iskusan pacijenata, генотипическое testiranje trebali bi se rukovoditi pri korištenju дарунавир (vidi 4. 2, 4. 3, 4. 4 i 5.

Krystexxa Euroopan unioni - kroatia - EMA (European Medicines Agency)

krystexxa

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.

Livmarli Euroopan unioni - kroatia - EMA (European Medicines Agency)

livmarli

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

Livogiva Euroopan unioni - kroatia - EMA (European Medicines Agency)

livogiva

theramex ireland limited - teriparatid - osteoporoza - homeostaza kalcija - livogiva is indicated in adults. liječenje osteoporoze u žena u postmenopauzi i muškaraca pri povećanom riziku od loma. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. liječenje osteoporoze, povezan sa stalnim sistemsku terapiju s glukokortikoidi, kod žena i muškaraca pod povećanim rizikom prijeloma.

Eladynos Euroopan unioni - kroatia - EMA (European Medicines Agency)

eladynos

theramex ireland limited - abaloparatide - osteoporosis, postmenopausal; osteoporosis - homeostaza kalcija - liječenje osteoporoze kod žena u postmenopauzi s povećanim rizikom od prijeloma.