Europska Unija - hrvatski - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - lamivudin - hepatitis b, kronični - antivirusni lijekovi za sustavnu uporabu - zeffix is indicated for the treatment of chronic hepatitis b in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. početak liječenja lamivudinom mora biti samo u slučaju, ako se korištenje alternativnih antivirusnih agenata s višim genetski barijera nisu dostupni ili odgovarajući;, декомпенсированной bolesti jetre u kombinaciji s drugi agent bez križne rezistencije na lamivudin.

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)

janssen-cilag international n.v. - дарунавир, кобицистат - hiv infekcije - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta, indicirana je u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje infekcije virusom humane imunodeficijencije 1 (hiv 1) u odraslih osoba starijih od 18 godina. Генотипическое testiranje trebali bi se rukovoditi pri korištenju rezolsta.

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - telbivudinom - hepatitis b, kronični - nukleozidni i nukleotidni inhibitori reverzne transkriptaze - sebivo je indiciran za liječenje kroničnog hepatitisa b u odraslih bolesnika s kompenziranom bolešću jetre i dokaza virusne replikacije, uporno povišene alanin aminotransferaze (alt) u serumu i histološki dokazanom aktivnom upalom i/ili fibroze. početak liječenja sebivo samo treba uzeti u obzir pri korištenju alternativnih antivirusni lijek s visokim genetskim barijera do otpornosti nisu dostupni ili odgovarajući.

Europska Unija - hrvatski - EMA (European Medicines Agency)

gilead sciences ireland uc - кобицистат - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (hiv-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international nv - simeprevir - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - olysio je indiciran u kombinaciji s drugim lijekovima za liječenje kroničnog hepatitisa c (chc) u odraslih bolesnika. virus hepatitisa c (hcv) genotip određene aktivnosti .

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - everolimus - tuberoza skleroza - antineoplastična sredstva - zatajenje angiomyolipoma povezane s клубневой kompleks skleroze (tsc)votubia indiciran za liječenje odraslih bolesnika s bubrežnim angiomyolipoma povezane s клубневой kompleks skleroze (tsc), koje se nalaze u grupi rizika za razvoj komplikacija (na temelju čimbenika kao što su veličina tumora ili postojanje aneurizme, ili prisutnost multi-i bilateralnih tumora), ali koji ne zahtijevaju hitnu kiruršku intervenciju. dokaz se oslanja na analizu promjena iznos volumena angiomyolipoma . Субэпендимальные гигантоклеточные astrocitom (СЭГА), koji su povezani s клубневой kompleks skleroze (tsc)votubia indiciran za liječenje bolesnika s субэпендимальные гигантоклеточные astrocitom (СЭГА), koji su povezani s клубневой kompleks skleroze (tsc), koji zahtijevaju terapijske intervencije, ali ne može biti kirurško liječenje. dokaz se oslanja na analizu promjena volumena sega . daljnja klinička prednosti, kao što je poboljšanje u bolesti povezane sa simptomima, nije dokazano.

Europska Unija - hrvatski - EMA (European Medicines Agency)

eli lilly nederland b.v. - baricitinib - artritis, reumatoidni - imunosupresivi - rheumatoid arthritisbaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). olumiant se može koristiti kao monoterapija ili u kombinaciji s metotreksatom. atopic dermatitisolumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. alopecia areatabaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5. juvenile idiopathic arthritisbaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic dmards:- polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [rf+] or negative [rf-], extended oligoarticular),- enthesitis related arthritis, and- juvenile psoriatic arthritis. baricitinib may be used as monotherapy or in combination with methotrexate.

Europska Unija - hrvatski - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19f - pneumococcal infections; immunization - cjepiva - aktivna imunizacija protiv invazivnih bolesti i akutnih otitis media uzrokovanih streptococcus pneumoniae kod dojenčadi i djece od šest tjedana do pet godina. pogledajte odjeljke 4. 4 i 5. 1 u informacijama o proizvodu za informacije o zaštiti od specifičnih pneumokoknih serotipova. primjena cjepivo synflorix mora odrediti na temelju službenih preporuka, uzimajući u obzir utjecaj invazivne bolesti u različitim dobnim skupinama, kao i varijabilnost серотип za epidemiologiju u različitim zemljopisnim područjima.

Europska Unija - hrvatski - EMA (European Medicines Agency)

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f - pneumococcal infections; immunization - cjepiva - aktivna imunizacija za prevenciju invazivnih bolesti, pneumonije i akutnog otitis medija uzrokovana streptococcus pneumoniae kod dojenčadi, djece i adolescenata od 6 tjedana do 17 godina starosti. aktivna imunizacija za sprječavanje invazivnih bolesti uzrokovane streptococcus pneumoniae kod odraslih ≥18 godina i starije. pogledajte odjeljke 4. 4 i 5. 1 za informacije o zaštiti od specifičnih pneumokoknih serotipova. korištenje Превенар 13 mora biti definiran na temelju službenih preporuka, uzimajući u obzir rizik od invazivnih bolesti u različitim dobnim skupinama, leži u osnovi srodne bolesti, kao i varijabilnost серотипа za epidemiologiju u različitim zemljopisnim područjima.