Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

amomed pharma gmbh, rakúsko - landiolol - 13 - antiarrythmica

Európska únia - slovenčina - EMA (European Medicines Agency)

ablynx nv - caplacizumab - purpura, thrombotic trombocytopenická - antitrombotické činidlá - cablivi je indikovaný na liečbu dospelých zažíva epizóda získané thrombotic trombocytopenická purpura (attp), v spojení s plazmovou výmenu a imunosupresiu.

Európska únia - slovenčina - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - autológne cd34+ buniek obohatený obyvateľstva, ktorý obsahuje hematopoietic stem cells transduced s lentiglobin bb305 lentiviral vektor kódovanie beta-a-t87q-globínu gén - beta-thalassemia - other hematological agents - zynteglo je indikovaný na liečbu pacientov 12 rokov a starších s transfúziu-závislé β thalassaemia (tdt), ktorí nemajú β0/β0 genotyp, pre ktorých hematopoetickú kmeňových buniek (hsc) transplantácie je vhodné, ale človek, leukocytové antigénu (hla)-uzavreté súvisiace hsc darcu nie je k dispozícii.

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

orion corporation, fínsko - metotrexát - 29 - antirheumatica, antiphlogistica, antiuratica

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

orion corporation, fínsko - metotrexát - 29 - antirheumatica, antiphlogistica, antiuratica

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

accord healthcare polska sp. z o.o., poľsko - klozapín - 68 - antipsychotica (neuroleptica)

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

accord healthcare polska sp. z o.o., poľsko - klozapín - 68 - antipsychotica (neuroleptica)

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

accord healthcare polska sp. z o.o., poľsko - klozapín - 68 - antipsychotica (neuroleptica)

Európska únia - slovenčina - EMA (European Medicines Agency)

accord healthcare s.l.u. - abiraterón acetátu - prostatické nádory - endokrinná terapia - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Európska únia - slovenčina - 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 - antineoplastické činidlá - 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. pacienti, ktorí majú nízky alebo veľmi nízke riziko opakovania by nemalo prijímať adjuvantná liečba. 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. okrem novo diagnostikovaných chronickej fáze cml, nie sú tam žiadne kontrolovaných štúdií dokazuje, klinický prospech alebo zvýšené prežitie týchto ochorení.