Europska Unija - slovenski - EMA (European Medicines Agency)

viiv healthcare b.v. - fostemsavir trometamol - okužbe z virusom hiv - antivirusi za sistemsko uporabo - rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Europska Unija - slovenski - 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.

Europska Unija - slovenski - EMA (European Medicines Agency)

bioprojet pharma - pitolisant - sleep apnea, obstructive - druga zdravila na živčnem sistemu - ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (eds) in adult patients with obstructive sleep apnoea (osa).

Europska Unija - slovenski - EMA (European Medicines Agency)

pfizer europe ma eeig - nirmatrelvir, ritonavir - covid-19 virus infection - paxlovid is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe covid 19.

Europska Unija - slovenski - EMA (European Medicines Agency)

accord healthcare s.l.u. - relugolix - prostatične neoplazme - endokrini terapija - orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.

Europska Unija - slovenski - EMA (European Medicines Agency)

pfizer europe ma eeig  - rimegepant - bolezni migrene - antimigraine preparations, calcitonin gene-related peptide (cgrp) antagonists - vydura is indicated for theacute treatment of migraine with or without aura in adults;preventative treatment of episodic migraine in adults who have at least 4 migraine attacks per month.

Europska Unija - slovenski - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - karcinom, pljučni pljuč - antineoplastična sredstva - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Europska Unija - slovenski - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - levkemija, mielogena, kronična, bcr-abl pozitivna - antineoplastična sredstva - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.

Europska Unija - slovenski - EMA (European Medicines Agency)

gilead sciences ireland unlimited company - lenacapavir sodium - okužbe z virusom hiv - antivirusi za sistemsko uporabo - sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant hiv 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4. 2 in 5. sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant hiv 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4. 2 in 5.

Europska Unija - slovenski - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - okužbe s citomegalovirusom - antivirusi za sistemsko uporabo - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). upoštevati je treba uradne smernice za ustrezno uporabo protivirusnih agenti.