Evropska unija - slovenščina - EMA (European Medicines Agency)

molmed spa - alogenskih t celice, gensko spremenjene z retrovirusni vektor kodiranje za skrajšani obliki ljudi nizko afiniteto živca rastni faktor receptor (Δlngfr) in herpes simplex virus timidin-kinazo (hsv-tk mut2) - hematopoietic stem cell transplantation; graft vs host disease - antineoplastična sredstva - zalmoxis je indiciran kot dodatno zdravljenje pri haploidentični hematopoetski presaditvi matičnih celic (hsct) pri odraslih bolnikih z visokim tveganjem hematoloških malignomov.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - bezlotoxumab - enterokolitis, pseudomembranous - imunski sera in imunoglobulini, - zdravilo zinplava je indicirano za preprečevanje ponovitve okužbe z clostridium difficile (cdi) pri odraslih z velikim tveganjem za ponovitev cdi.

Evropska unija - slovenščina - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - granisetron - vomiting; cancer - antiemetics in antinauseants, serotonina (5ht3) antagonisti - preprečevanje navzee in bruhanja pri bolnikih, ki prejemajo zmerno ali visoko emetogeno kemoterapijo, z ali brez cisplatina, do pet zaporednih dni. sancuso se lahko uporablja pri bolnikih, ki prejemajo svojo prvo kemoterapijo režim, ali pri bolnikih, ki so že prejeli kemoterapijo.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sanofi winthrop industrie - klopidogrel vodikov sulfat - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - antitrombotična sredstva - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease;adult patients suffering from acute coronary syndrome: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 patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic stroke (is)clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. preprečevanje atherothrombotic in thromboembolic dogodkov v atrijska fibrillationin odraslih bolnikov z atrijsko fibrilacijo, ki imajo vsaj en dejavnik tveganja za žilne dogodke, niso primerni za zdravljenje z vitaminom k antagonisti in ki imajo nizko tveganje krvavitve, clopidogrel je indiciran v kombinaciji s asa za preprečevanje atherothrombotic in thromboembolic dogodkov, vključno z možgansko kap.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited  - vildagliptin, metformin hidroklorid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - zomarist 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

Evropska unija - slovenščina - EMA (European Medicines Agency)

biogen netherlands b.v. - dimetil fumarat - multiple skleroza - imunosupresivi - tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - vorikonazol - aspergillosis; candidiasis; mycoses - antimycotics za sistemsko uporabo, triazol derivati - voriconazole je v širokem spektru, triazol protiglivično sredstvo, ter je označena pri odraslih in otrocih, starih dve leti ali več, kot sledi:zdravljenje invazivne aspergillosis;zdravljenje candidaemia v ne-neutropenic bolnikov;zdravljenje fluconazole-odporne resno invazivne candida okužbe (vključno c. krusei);zdravljenje hude glivične okužbe, ki jih povzročajo scedosporium spp. in oxysporum spp. voriconazole soglasju mora biti urejen, predvsem pri bolnikih z napredujočo, morda celo smrtno nevarne okužbe.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - 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 in 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. glede na odločitev, da začne zdravljenje v pediatrični bolniki glej točki 4. 2, 4. 4 in 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 in 5. za virus hepatitisa c (hcv) genotip določene dejavnosti, glej točki 4. 2 in 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. ko se odločate za začetek zdravljenja v otroštvu, je pomembno, da preuči zaviranja rasti povzročijo kombinacija terapije. reverzibilnost zaviranja rasti je negotova. odločitev za zdravljenje mora biti vložena na podlagi primera (glej poglavje 4.

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatitis c, kronični - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 in 5. za virus hepatitisa c (hcv) genotip-specifična aktivnost glej točki 4. 4 in 5.