Europska Unija - hrvatski - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - selektivni imunosupresivi - colitisentyvio ulcerozni indiciran za liječenje odraslih bolesnika s вмеру na strogo aktivno язвенному колиту, koji su imali neadekvatan odgovor, izgubila odgovor, ili iz netrpeljivosti ili tradicionalne terapije ili faktor nekroze tumora alfa (Фноа) antagonist. diseaseentyvio kruna je indiciran za liječenje odraslih bolesnika s bolešću reumatoidnim kruna, koji su imali neadekvatan odgovor, izgubila odgovor, ili iz netrpeljivosti ili tradicionalne terapije ili faktor nekroze tumora alfa (Фноа) antagonist. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

takeda pharma a/s - fentanil citrat - pain; cancer - analgetici - instanyl je indiciran za upravljanje probavnom boli kod odraslih koji već primaju opioidnu terapiju za kroničnu bol u raku. probijanje boli je prolazno pogoršanje boli koja se javlja na pozadini drugačije kontrolirane upornosti boli.  patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Europska Unija - hrvatski - EMA (European Medicines Agency)

takeda pharma a/s - alogliptin benzoat, метформина hidroklorid - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - vipdomet is indicated in the treatment of adult patients aged 18 years and older with type-2 diabetes mellitus:as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin;in combination with pioglitazone (i. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone;in combination with insulin (i. trostruka kombinirana terapija) kao dodatak prehrani i fizičke vježbe za poboljšanje glikemijski kontrole kod bolesnika, kada inzulina u stabilne doze i metformin sami ne pružaju adekvatnu glikemijski kontrole.

Europska Unija - hrvatski - EMA (European Medicines Agency)

leo pharma a/s - tralokinumab - dermatitis, atopic - ostali dermatološki pripravci - adtralza is indicated for the treatment of moderate to severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ucb pharma s.a.   - bimekizumab - psorijaza - imunosupresivi - plaque psoriasisbimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritisbimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (dmards). axial spondyloarthritisnon-radiographic axial spondyloarthritis (nr-axspa)bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (nsaids). ankylosing spondylitis (as, radiographic axial spondyloarthritis)bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ucb pharma s.a.   - fenfluramine hydrochloride - epilepsies, myoclonic - antiepileptici sredstva, - treatment of seizures associated with dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older. fintepla is indicated for the treatment of seizures associated with dravet syndrome and lennox-gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tenofovir disoproksil - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - hiv-1 infectiontenofovir дизопроксила 245 mg tablete, prekriven membranom su navedeni u kombinaciji s drugim антиретровирусными lijekovima za liječenje hiv-1 zaraženih odraslih. kod odraslih, demonstracija naknade тенофовира дизопроксила u hiv-1 infekcije temelji se na rezultatima jednog istraživanja u liječenju naivnih pacijenata, uključujući i bolesnike s visokim virusnim opterećenjem (> 100 000 kopija/ml) i istraživanja, u kojima Тенофовир дизопроксил je dodao da je u stabilnom usred terapije (uglavnom тритерапия) u антиретровирусной pre-tretiranih bolesnika doživljava rano вирусологическая neuspjeh (< 10 000 kopija/ml, pri čemu većina pacijenata koji imaju < 5 000 kopija/ml). Тенофовира дизопроксила 245 mg filmom obložena tableta također je propisan za liječenje hiv-1-zaražene mlade otpor НИОТ ili toksičnosti, isključuje primjena prve linije agenata, u dobi od 12 do < 18 godina. izbor тенофовира дизопроксила za liječenje arv-iskusan pacijenata s hiv-1 infekcije mora se temeljiti na individualnoj virusne rezistencije ispitivanje i/ili za liječenje, priče pacijenata. hepatitis b infectiontenofovir дизопроксила 245 mg filmom obložena tableta je indiciran za liječenje kroničnog hepatitisa b u odraslih s:компенсированным oboljenja jetre, sa znakovima aktivnu replikaciju virusa, stalno povišena razina аланинаминотрансферазы (alt) i гистологических znakova aktivne upale i/ili fibroze. dokaza lamivudin-резистентного virusa hepatitisa b . dekompenziranom bolesti jetre . Тенофовира дизопроксила 245 mg filmom obložena tableta je indiciran za liječenje kroničnog hepatitisa b u adolescenata od 12 do < 18 godina sa компенсированным bolesti jetre i znakova imunološki aktivne bolesti, ja sam. aktivne replikacije virusa, stalno povišena razina alt u serumu i гистологических znakova aktivne upale i/ili fibroze.

Europska Unija - hrvatski - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - antineoplastična sredstva - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amarin pharmaceuticals ireland limited - icosapent ethyl - dislipidemije - sredstva za modifikaciju lipida - indicated to reduce cardiovascular risk as an adjunct to statin therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - azacitidin - leukemija, mieloidna, akutna - antineoplastična sredstva - onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (aml) who achieved complete remission (cr) or complete remission with incomplete blood count recovery (cri) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (hsct).