Azacitidine Mylan Uniunea Europeană - slovenă - EMA (European Medicines Agency)

azacitidine mylan

mylan ireland limited - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastična sredstva - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

Azacitidine Accord Uniunea Europeană - slovenă - EMA (European Medicines Agency)

azacitidine accord

accord healthcare s.l.u. - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastična sredstva - azacitidine soglasju je indicirano za zdravljenje odraslih bolnikih, ki niso primerni za haematopoietic stem cell presaditev (hsct) z:- intermediate-2 in visokim tveganjem myelodysplastic sindromov (mds) je v skladu z mednarodnim prognostic sistem točkovanja (ipss),- kronično myelomonocytic levkemijo (cmml) z 10-29 % mozga eksplozije brez myeloproliferative motnje,- akutno mieloično levkemijo (aml) z 20-30 % blastov in multi-rodbine displazija, po ocenah svetovne zdravstvene organizacije (who), in razvrščanje,- aml s >30% mozgu eksplozije glede na razvrstitev, ki.

Beovu Uniunea Europeană - slovenă - EMA (European Medicines Agency)

beovu

novartis europharm limited  - brolucizumab - mokra makularna degeneracija - oftalmologi - beovu je navedeno pri odraslih za zdravljenje neovascular (mokro) starostna degeneracija rumene pege (amd).

Roclanda Uniunea Europeană - slovenă - EMA (European Medicines Agency)

roclanda

santen oy - latanoprost, netarsudil mesilate - glaucoma, open-angle; ocular hypertension - oftalmologi - roclanda is indicated for the reduction of elevated intraocular pressure (iop) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient iop reduction.

Thiotepa Riemser Uniunea Europeană - slovenă - EMA (European Medicines Agency)

thiotepa riemser

esteve pharmaceuticals gmbh - tiotepa - hematopoietic stem cell transplantation; neoplasms - antineoplastična sredstva - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Vazkepa Uniunea Europeană - slovenă - EMA (European Medicines Agency)

vazkepa

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

Imatinib Koanaa Uniunea Europeană - slovenă - EMA (European Medicines Agency)

imatinib koanaa

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.

Byooviz Uniunea Europeană - slovenă - EMA (European Medicines Agency)

byooviz

samsung bioepis nl b.v. - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; myopia, degenerative - oftalmologi - byooviz is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).