Gonazon Európai Unió - magyar - EMA (European Medicines Agency)

gonazon

intervet international bv - azagli-nafarelin - hipofízis és hypothalamus hormonok és analógok - dogs; salmonidae (salmonid fish) - női lazacos halak, például a lazac (salmo salar), szivárványos pisztráng (oncorhynchus mykiss), barna pisztráng (salmo trutta), valamint az északi-sarkvidék charr (salvelinus alpinus)indukciós, majd a szinkronizálás az ovuláció a termelés szemű-tojást, majd fry. kutyák (szukák)megelőzés ivari működés a szukák keresztül hosszú távú blokád a gonadotropin-szintézis.

Edistride Európai Unió - magyar - EMA (European Medicines Agency)

edistride

astrazeneca ab - dapagliflozin-propándiol-monohidrát - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - cukorbetegségben szedett gyógyszerek - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. amellett, hogy egyéb gyógyszerekkel a kezelés a 2-es típusú cukorbetegség. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5. és 5. sz. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

Forxiga Európai Unió - magyar - EMA (European Medicines Agency)

forxiga

astrazeneca ab - dapagliflozin-propándiol-monohidrát - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - cukorbetegségben szedett gyógyszerek - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. amellett, hogy egyéb gyógyszerekkel a kezelés a 2-es típusú cukorbetegség. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5. és 5. sz. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Glivec Európai Unió - magyar - EMA (European Medicines Agency)

glivec

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - daganatellenes szerek - 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. , a glivec hatását, az eredmény, a csontvelő-átültetés nem határozták meg. 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. azok a betegek, akik alacsony, vagy nagyon alacsony kiújulás kockázata nem kaphat adjuváns kezelés; a felnőtt betegek kezelésére inoperábilis dermatofibrosarcoma protuberans (dfsp) szenvedő felnőtt betegek visszatérő és / vagy áttétes dfsp, akik nem jogosultak a műtét. a felnőtt, gyermek beteg, a hatékonysága a glivec-et alapul, általános hematológiai, citogenetikai válasz árak, illetve a progressziómentes túlélés cml-ben, a hematológiai, citogenetikai válasz árak a ph+ all, mds / mpd, a hematológiai válasz árak a hes / cel, objektív választ árak a felnőtt betegek inoperábilis és / vagy áttétes lÉnyeg, dfsp, illetve a kiújulás-mentes túlélés adjuváns gist. a glivec a betegek mds / mpd kapcsolódó pdgfr gén újra szabályok nagyon korlátozott (lásd 5. kivéve, hogy az újonnan diagnosztizált, krónikus fázisú cml-nincs kontrollált vizsgálatok, amelyek klinikai haszon vagy fokozott túlélés ezek a betegségek.

Iclusig Európai Unió - magyar - EMA (European Medicines Agency)

iclusig

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. lásd a 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Imatinib Accord Európai Unió - magyar - EMA (European Medicines Agency)

imatinib accord

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. kivéve, hogy az újonnan diagnosztizált, krónikus fázisú cml-nincs kontrollált vizsgálatok, amelyek klinikai haszon vagy fokozott túlélés ezek a betegségek. .

Imatinib Actavis Európai Unió - magyar - 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. a hatás az imatinib az eredmény, csontvelő-transzplantáció nem határozták meg. 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. a tapasztalatok imatinib a betegek mds/mpd kapcsolódó pdgfr gén újra szabályok nagyon korlátozott. nincs kontrollált vizsgálatok, amelyek klinikai haszon vagy fokozott túlélés ezek a betegségek.