Evropska unija - slovenščina - EMA (European Medicines Agency)

krka, d.d., novo mesto - emtricitabine, tenofovir disoproxil succinate - okužbe z virusom hiv - antivirusi za sistemsko uporabo - emtricitabin / tenofovirdizoproksil krka d. je indiciran pri protiretrovirusnem kombiniranem zdravljenju za zdravljenje odraslih, okuženih s hiv-1. emtricitabin / tenofovirdizoproksil krka d. je tudi navedeno, za zdravljenje okužbe z virusom hiv-1 okuženih mladostniki, z nrti odpornost ali toxicities nasprotuje uporabi prvo vrstico agenti, starih od 12 < 18 let.

Evropska unija - slovenščina - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir, cobicistat, emtricitabine, tenofovir alafenamide - okužbe z virusom hiv - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - zdravilo symtuza je indicirano za zdravljenje okužbe z virusom humane imunske pomanjkljivosti tipa 1 (hiv-1) pri odraslih in mladostnikih (starih 12 let in več, z telesno maso najmanj 40 kg). genotypic testing should guide the use of symtuza.

Evropska unija - slovenščina - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - glecaprevir, pibrentasvir - hepatitis c, kronični - antivirusi za sistemsko uporabo - maviret is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults and children aged 3 years and older. maviret coated granules is indicated for the treatment of chronic hepatitis c virus (hcv) infection in children 3 years and older.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sanofi b.v. - eliglustat - gaucher bolezen - drugi zdravljene bolezni prebavil in presnove izdelki, - cerdelga je indicirano za dolgotrajno zdravljenje odraslih bolnikov s gaucher boleznijo tipa 1 (gd1), ki so slabo metabolisers cyp2d6 (pms), vmesni metabolisers (ims) ali obsežne metabolisers (ems).

Evropska unija - slovenščina - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastična sredstva - imatinib koanaa is indicated for the treatment ofadult and 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. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric 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-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment. 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. 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 gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Evropska unija - slovenščina - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastična sredstva - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Evropska unija - slovenščina - EMA (European Medicines Agency)

alfasigma s.p.a. - piperaquine tetraphosphate, artenimol - malarija - antiprotozoals - eurartesim je indicirano za zdravljenje nezapleteno plasmodium falciparum malarije odrasle, otroke in dojenčke 6 mesecev in več in tehta 5 kg ali več. upoštevati je treba uradne smernice za ustrezno uporabo proti malariji agenti.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

krka, d.d., novo mesto - rosuvastatin - filmsko obložena tableta - rosuvastatin 10 mg / 1 tableta - rosuvastatin

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

krka, d.d., novo mesto - rosuvastatin - filmsko obložena tableta - rosuvastatin 15 mg / 1 tableta - rosuvastatin

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

stada arzneimittel ag - rosuvastatin - filmsko obložena tableta - rosuvastatin 40 mg / 1 tableta - rosuvastatin