สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastična sredstva - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - karcinom, ne-malih stanica pluća - antineoplastična sredstva - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

acino ag - klopidogrel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - antitrombotska sredstva - clopidogrel is indicated in adults for the prevention of atherothrombotic events in: , , , patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease, non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa), st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy, patients suffering from acute coronary syndrome. , ,.

สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - Иммуностимуляторы, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4. 4 i 5. paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. s poštovanjem za rješavanje započeti liječenje u pedijatrijska bolesnika vidi 4. 2, 4. 4 i 5. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4. 2, 4. 4 i 5. virus hepatitisa c (hcv) genotip određene aktivnosti, vidi 4. 2 i 5. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. pri rješavanju početak liječenja u dječjoj dobi, važno je uzeti u obzir inhibicija rasta, izazvana kombinovanu terapiju. Обратимость inhibicije rasta povjerenja. odluka mora biti donesena na individualnoj osnovi (vidi odjeljak 4.

สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

n.v. organon - asenapine (as maleate)  - bipolarni poremećaj - psycholeptics - sycrest je indiciran za liječenje umjerenih do teških maničnih epizoda povezanih s bipolarnim poremećajem u odraslih osoba.

สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripiprazola - schizophrenia; bipolar disorder - psycholeptics - abilify je indiciran za liječenje shizofrenije kod odraslih i adolescenata starijih od 15 godina. Абилифай je indiciran za liječenje umjerene do teških maničnih epizoda kada je bipolarni poremećaj poremećaj i za prevenciju novog manic epizoda kod odraslih, koji su doživjeli pretežno manične epizode, a čiji je manične epizode odgovorio na liječenje арипипразолом. Абилифай indiciran za liječenje do 12 tjedana umjerenih i teških maničnih epizoda u bipolarni poremećaj kod adolescenata u dobi od 13 godina i stariji.

สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

eli lilly nederland b.v. - duloksetin - anxiety disorders; diabetic neuropathies; depressive disorder, major - psychoanaleptics, - liječenje većeg depresivnog poremećaja. liječenje dijabetičke periferne neuropatske boli. liječenje generalizirani anksiozni poremećaj . cymbalta navodi u odraslih.

สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

zentiva, k.s. - duloksetin - neuralgia; depressive disorder, major; anxiety disorders; diabetes mellitus - ostali antidepresivi - liječenje depresivnog poremećaja, dijabetička neuropatska bol, poremećaj anksioznosti. setin Зентива navodi u odraslih.

สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

sandoz gmbh - somatropin - turner syndrome; prader-willi syndrome; dwarfism, pituitary - hipofiza i hipotalamusni hormoni i analozi - dojenčadi, djece i kršenje adolescentsgrowth zbog neadekvatne sekrecije hormona rasta (gh). poremećaj rasta povezane s turnerovim sindromom. poremećaj rasta povezuju s kroničnom bubrežnom insuficijencijom. poremećaj rasta (trenutni standard-odstupanje visine rezultat (ИКБ) < -2. 5 i roditeljskim prilagoditi СДС < -1) ukratko djeca / adolescenti rođen je mali za gestacijski dobi (muh), od rođenja, težinu i / ili dužina ispod -2 standardne devijacije (СДС), koji nije uspio pokazati догоняющий rast (visina, brzina (bih) СДС < 0, u roku od prošle godine) do četiri godine ili kasnije. prader-willi sindrom (ПВС), za poboljšanje rasta i strukture tijela, . dijagnoza ПВС mora biti potvrđena odgovarajućim genetičko testiranje. adultsreplacement terapija u odraslih s izražen nedostatak hormona rasta . u bolesnika s izražen nedostatak hormona rasta u odrasloj dobi definirana kao bolesnika s poznatom гипоталамо-hipofiza bolestima i barem jedan istaknuti nedostatak hormona hipofize пролактина, ne bude. ovi bolesnici moraju proći jedan dinamički test kako bi se dijagnosticirati ili isključiti nedostatak hormona rasta . u bolesnika s dječjim dijabetesom izolirani СТГ srca (bez znakova гипоталамо-гипофизарным bolest ili zračenje mozga), dva dinamička ispitivanja treba preporučiti, osim onih koji imaju nisku razinu inzulina kao faktora rasta-i (ИРФ-i) u koncentraciji (СДС < -2), koji se može smatrati za jednog testa. točku clipping, dinamičkog testa mora biti stroga.

สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

h. lundbeck a/s - vortioxetine - depresivni poremećaj, bojnik - psychoanaleptics, - liječenje glavnih depresivnih epizoda kod odraslih osoba.