الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

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.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberkuloza, višestruko otporna - antimikobakterija - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - zoledronske kiseline - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - lijekovi za liječenje bolesti kostiju - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture, including those with a recent low-trauma hip fracture. liječenje osteoporoze, povezan s dugoj sistemske glukokortikoidni terapije kod žena u postmenopauzi i muškaraca sa povećanim rizikom od prijeloma. liječenje pagetova bolest kostiju.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

viiv healthcare b.v. - maraviroka - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only ccr5-tropic hiv-1 detectable,.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

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.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

viiv healthcare bv - dolutegravir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

mylan pharmaceuticals limited - entekavijev monohidrat - hepatitis b - antivirusni lijekovi za sustavnu uporabu - entecavir mylan is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. dekompenziranom bolesti jetre . kao компенсированные i dekompenziranom bolesti jetre, ovaj pokazatelj temelji se na podacima iz kliničkih istraživanja u naivnih pacijenata nukleozida s pozitivnim rezultatom testa na hbeag i hbeag-negativni hbv-infekcije. Što se tiče bolesnika s refluksom hepatitis b lamivudina. Энтекавир mylan u je također indiciran za liječenje kronične hbv-infekcije u nukleozida naivan pedijatrijska bolesnika od 2 do.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioedemas, nasljedni - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

الاتحاد الأوروبي - الكرواتية - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroksaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitrombotska sredstva - prevencija venske tromboembolije (vte) u odraslih bolesnika koji se podvrgavaju izborni operacije zamjena kuka ili koljena. liječenje tromboze dubokih vena (dvt) i plućne embolije (ТЭЛА) i prevenciju recidiva dvt i ТЭЛА kod odraslih. (see section 4. 4 for haemodynamically unstable pe patients. liječenje tromboze dubokih vena (dvt) i plućne embolije (ТЭЛА) i prevenciju recidiva dvt i ТЭЛА kod odraslih. (see section 4. 4 za hemodinamski nestabilne ТЭЛА pacijenata). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. liječenje tromboze dubokih vena (dvt) i plućne embolije (ТЭЛА) i prevenciju recidiva dvt i ТЭЛА kod odraslih. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 i 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. liječenje tromboze dubokih vena (dvt) i plućne embolije (ТЭЛА) i prevenciju recidiva dvt i ТЭЛА kod odraslih. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.