Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

ucb pharma sa - brivaracetam - epilepsija - antiepileptici sredstva, - briviact je indiciran kao pomoćna terapija u liječenju parcijalnih napadaja s ili bez sekundarne generalizacije u odraslih i adolescentnih bolesnika od 16 godina s epilepsijom.

Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

viatris healthcare limited - fenofibrate, simvastatin - dislipidemije - sredstva za modifikaciju lipida - cholib je indiciran kao dodatna terapija dijeti i tjelovježbi u odraslih bolesnika visokim s mješovitim dislipidemijom za smanjenje triglicerida i povećanje razine hdl c kad ldl c razinama adekvatno upravlja pomoću odgovarajuće doze monoterapije simvastatinom.

Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

merck sharp dohme limited - lamivudin, ралтегравир kalija - hiv infekcije - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis je indiciran u kombinaciji s drugim anti‑retroviral lijekovima za liječenje humane imunodeficijencije (hiv‑1) infekcija u odraslih, adolescenata i djece u dobi od 6 godina i tjelesne težine najmanje 30 kg bez sadašnjosti ili prošlosti dokaz virusne otpornosti na antivirusne lijekove institucije (rezistencije strand prijenos inhibitor) i eng. (inhibitor reverzne transkriptaze nukleozida) klase (vidjeti dio 4. 2, 4. 4 i 5.

Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

teva pharma b.v. - tableta - parkinsonova bolest - antiparkinsonski lijekovi - entacapone je indiciran kao dodatak standardnim pripremama levodope / benserazide ili levodope / carbidopa u odraslih bolesnika s parkinsonovom bolesti i kraju doze motoričke fluktuacije, koji mogu biti stabilizirani te kombinacije.

Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

novartis europharm limited - вилдаглиптин, metformin hidroklorid - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - eucreas is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

medimmune llc - Реассортанта virusa gripe (live аттенуированная) sljedećih sojeva:a/california/7/2009 pdm09 (Н1n1)kao soj a/victoria/361/2011 (Н3n2), kao što su napon, b/ma/2/2012 kao soj - influenza, human; immunization - cjepiva - profilaksa gripe kod osoba od 24 mjeseca do 18 godina starosti. korištenje fluenz mora se temeljiti na službenim preporukama.

Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

novartis europharm limited - вилдаглиптин, metformin hidroklorid - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 i 5. 1 za dostupne podatke o različitim kombinacijama).

Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. učinak иматиниба na ishod transplantacije koštane srži nije određena. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. iskustvo s иматинибом u bolesnika s mds/rafinerija u svezi s pdgfr генных permutacija-vrlo ograničen. nema kontroliranih istraživanja pokazuju kliničku korist ili povećanje preživljavanja za te bolesti.

Ευρωπαϊκή Ένωση - Κροατικά - EMA (European Medicines Agency)

novartis europharm limited - travoprost - ocular hypertension; glaucoma, open-angle - ophthalmologicals, antiglaucoma preparations and miotics - smanjenje povišenog intraokularnog tlaka kod odraslih bolesnika s okularnom hipertenzijom ili glaukomom otvorenog kuta (vidjeti odjeljak 5. smanjenje povećanog od intraokularna tlaka u pedijatrijski bolesnici u dobi od 3 godine < 18 godina sa očni hipertenzije ili dijete glaukoma.