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

baxalta innovations gmbh, rakúsko - koagulačný faktor vii - 16 - anticoagulantia (fibrinolytica, antifibrinol.)

Európska únia - slovenčina - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastické činidlá - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. Ďalšie informácie o stave receptora ľudského epidermálneho rastového faktora 2 (her2) nájdete v časti 5. 1 of the smpc. aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. Ďalšie informácie o stave her2 nájdete v časti 5. 1 of the smpc. aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. 1 of the smpc). aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. 1 of the smpc). aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5. 1 of the smpc).

Európska únia - slovenčina - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastické činidlá - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. Ďalšie informácie o stave receptora ľudského epidermálneho rastového faktora 2 (her2) nájdete v časti 5. onbevzi in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with onbevzi in combination with capecitabine. Ďalšie informácie o stave her2 nájdete v časti 5. onbevzi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. onbevzi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. onbevzi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. onbevzi, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. onbevzi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Európska únia - slovenčina - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - gastrointestinálne stromálne nádory - iné antineoplastické činidlá, protein kinase inhibítory - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

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.

Európska únia - slovenčina - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord 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-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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. 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)

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. Účinok imatinib o výsledku transplantáciu kostnej drene nebola stanovená. 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. skúsenosti s imatinib u pacientov s mds/mpd spojené s pdgfr gén re-opatrenia je veľmi obmedzený. nie sú žiadne kontrolovaných štúdií dokazuje, klinický prospech alebo zvýšené prežitie týchto ochorení.

Európska únia - slovenčina - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva je indikovaný na liečbu ofadult a pediatrických pacientov s novo diagnostikovanou chromozóm philadelphia (bcr‑abl) pozitívne (ph+) chronická myeloidná leukémia (cml), pre ktorých je transplantáciu kostnej drene nie je považované za prvú líniu liečby. pre dospelých a pediatrických pacientov s ph+ cml) v chronickej fáze po neúspechu interferónu‑alfa terapia, alebo v zrýchlenej fáze alebo výbuch krízy. pre dospelých a pediatrických pacientov s novo diagnostikovanou chromozóm philadelphia pozitívne acute lymphoblastic leukémia (ph+ all) integrovaný s chemoterapiou. u dospelých pacientov s relapsed alebo žiaruvzdorné ph+ all, ako monotherapy. u dospelých pacientov s myelodysplastic/myeloproliferative ochorenia (mds/mpd), spojené s krvných doštičiek-derived growth factor receptor (pdgfr) gén re-opatrenia. u dospelých pacientov s pokročilým hypereosinophilic syndróm (hes) alebo chronická eozinofilná leukémia (cel) s fip1l1-pdgfra prestavby. Účinok imatinib o výsledku transplantáciu kostnej drene nebola stanovená. imatinib teva 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 - ribociclib sukcinát - neoplazmy prsníkov - antineoplastické činidlá - kisqali je indikovaný na liečbu žien s hormonálne receptory (hr)‑pozitívnu, ľudskej pokožky growth factor receptor 2 (her2)‑negatívne lokálne pokročilého alebo metastatického karcinómu prsníka v kombinácii s inhibítor aromatázy alebo fulvestrant ako počiatočné žliaz s vnútornou sekréciou-založené terapie, alebo u žien, ktoré dostali pred žliaz s vnútornou sekréciou, terapia. v pre‑ alebo perimenopauzálnych žien, endokrinný terapie by mali byť kombinované s lutenizačného hormónu‑uvoľňujúci hormón (lhrh) agonist.

Európska únia - slovenčina - EMA (European Medicines Agency)

pfizer europe ma eeig - bevacizumab - colorectal neoplasms; breast neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastické činidlá - zirabev v kombinácii s fluoropyrimidine-založené chemoterapia je indikovaný na liečbu dospelých pacientov s metastatickým karcinóm hrubého čreva alebo konečníka. zirabev v kombinácii s paclitaxel je uvedené v prvej línii liečby dospelých pacientov s metastatického karcinómu prsníka. pre ďalšie informácie, ako sa k ľudskej pokožky growth factor receptor 2 (her2) stav. zirabev, okrem platinum-založené chemoterapia je uvedený na prvej línie liečby dospelých pacientov s unresectable pokročilým, metastatickým alebo recidivujúcim non-small cell lung cancer iné ako prevažne dlaždicových buniek histology. zirabev v kombinácii s interferónom alfa-2a je uvedené pre prvý riadok liečbu dospelých pacientov s pokročilým a/alebo metastatickým obličiek bunky rakoviny. zirabev, v kombinácii s paclitaxel a cisplatin, alebo, alternatívne, paclitaxel a topotecan v pacienti, ktorí nemôžu dostávať platinum terapia, je indikovaný na liečbu dospelých pacientov s perzistentné, opakujúce, alebo metastatickým karcinóm krčka maternice.