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.

Európska únia - slovenčina - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastické činidlá - glivec is indicated for the treatment of , adult 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-pdgfra rearrangement. Účinok glivec na výsledok kostnej drene transplantácia nebola stanovená. glivec is indicated for: , the 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 adjuvantnej liečby, liečba dospelých pacientov s unresectable dermatofibrosarcoma protuberans (dfsp) a u dospelých pacientov s recidivujúcim a / alebo metastatickým dfsp, ktorí nie sú akceptovateľné pre operácie. , u dospelých a pediatrických pacientov, účinnosť glivec je založené na celkovej hematologické a cytogenetic odpoveď ceny a postup-zadarmo prežitie v cml, na hematologické a cytogenetic miera odozvy v ph+ all, mds / mpd, na hematologické miera odozvy v hes / cel a na cieľ miera odozvy u dospelých pacientov s unresectable a / alebo metastatickým podstata a dfsp a na opakovanie-free prežitie v adjuvantnej tÉmou. skúsenosti s glivec u pacientov s mds / mpd spojené s pdgfr gén re-opatrenia je veľmi obmedzené (pozri časť 5. okrem novo diagnostikovaných chronickej fáze cml, nie sú tam žiadne kontrolovaných štúdií dokazuje, klinický prospech alebo zvýšené prežitie týchto ochorení.

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

egis pharmaceuticals plc, maďarsko - bendamustín - 44 - cytostatica

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

sandoz pharmaceuticals d.d., slovinsko - bendamustín - 44 - cytostatica

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

accord healthcare polska sp. z o.o., poľsko - bendamustín - 44 - cytostatica

Európska únia - slovenčina - EMA (European Medicines Agency)

amgen europe b.v. - carfilzomib - viacnásobný myelóm - antineoplastické činidlá - kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

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

egis pharmaceuticals plc, maďarsko - imatinib - 44 - cytostatica

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

egis pharmaceuticals plc, maďarsko - imatinib - 44 - cytostatica

Európska únia - slovenčina - EMA (European Medicines Agency)

hra pharma rare diseases - ketokonazol - cushingov syndróm - antimykotika na systémové použitie - ketokonazol hra je indikovaný na liečbu endogénneho cushingovho syndrómu u dospelých a adolescentov vo veku nad 12 rokov.

Európska únia - slovenčina - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - talidomid - viacnásobný myelóm - imunosupresíva - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.