Xtandi 유럽 연합 - 체코어 - EMA (European Medicines Agency)

xtandi

astellas pharma europe b.v. - enzalutamid - prostatetické novotvary - endokrinní terapie - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Abiraterone Accord 유럽 연합 - 체코어 - EMA (European Medicines Agency)

abiraterone accord

accord healthcare s.l.u. - abirateron acetátu - prostatetické novotvary - endokrinní terapie - 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.

Tolvaptan Accord 유럽 연합 - 체코어 - EMA (European Medicines Agency)

tolvaptan accord

accord healthcare s.l.u. - tolvaptan - nevhodný syndrom adh - diuretika, - tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (siadh).

Nubeqa 유럽 연합 - 체코어 - EMA (European Medicines Agency)

nubeqa

bayer ag - darolutamide - prostaty, nádorů, kastrace-odolné - endokrinní terapie - nubeqa is indicated for the treatment of adult men with- non metastatic castration resistant prostate cancer (nmcrpc) who are at high risk of developing metastatic disease (see section 5. - metastatic hormone sensitive prostate cancer (mhspc) in combination with docetaxel and androgen deprivation therapy (see section 5.

Abiraterone Krka 유럽 연합 - 체코어 - EMA (European Medicines Agency)

abiraterone krka

krka, d.d., novo mesto - abirateron acetátu - prostatetické novotvary - endokrinní terapie - abiraterone krka 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) (see section 5. 1)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 indicated (see section 5. 1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

AMIODARON HAMELN 20MG/ML Infuzní roztok 체코 - 체코어 - SUKL (Státní ústav pro kontrolu léčiv)

amiodaron hameln 20mg/ml infuzní roztok

hameln pharma gmbh, hameln array - 3333 amiodaron-hydrochlorid - infuzní roztok - 20mg/ml - amiodaron

IRINOTECAN PHARMAGEN 20MG/ML Koncentrát pro infuzní roztok 체코 - 체코어 - SUKL (Státní ústav pro kontrolu léčiv)

irinotecan pharmagen 20mg/ml koncentrát pro infuzní roztok

pharmagen cz s.r.o., praha array - 14658 trihydrÁt irinotekan-hydrochloridu - koncentrát pro infuzní roztok - 20mg/ml - irinotekan

Imatinib Actavis 유럽 연합 - 체코어 - EMA (European Medicines Agency)

imatinib actavis

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, 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. Účinek imatinibu na výsledek transplantace kostní dřeně nebyl stanoven. imatinib actavis is indicated for: , 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 dfsp. zkušenosti s imatinibem u pacientů s mds/mpd spojeným se změnou genu receptoru pdgfr jsou velmi omezené. nejsou k dispozici žádné kontrolované studie, které by prokázaly klinický přínos nebo prodloužené přežití u těchto uvedených onemocnění.

ARDEAELYTOSOL D 1/1 Infuzní roztok 체코 - 체코어 - SUKL (Státní ústav pro kontrolu léčiv)

ardeaelytosol d 1/1 infuzní roztok

ardeapharma, a.s., Ševětín array - 1322 chlorid sodnÝ; 1174 chlorid draselnÝ; 1334 natrium-laktÁt - infuzní roztok - elektrolyty

ARDEAELYTOSOL EA 1/1 Infuzní roztok 체코 - 체코어 - SUKL (Státní ústav pro kontrolu léčiv)

ardeaelytosol ea 1/1 infuzní roztok

ardeapharma, a.s., Ševětín array - 1322 chlorid sodnÝ; 1174 chlorid draselnÝ; 2776 hexahydrÁt chloridu vÁpenatÉho; 856 hexahydrÁt chloridu hoŘeČnatÉho; 1306 trihydrÁt natrium-acetÁtu - infuzní roztok - elektrolyty