Den europeiske union - slovensk - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Den europeiske union - slovensk - EMA (European Medicines Agency)

bayer animal health gmbh - imidacloprid, moxidectin - antiparazitni izdelki, insekticidi in repelenti - dogs; cats; ferrets - dogsfor psi, ki trpijo ali na tveganje, mešani parazitske okužbe:zdravljenje in preprečevanje bolh okužbe (ctenocephalides felis),zdravljenje grize lice (trichodectes canis),zdravljenje uho tropilaelaps okužbe (otodectes cynotis), sarcoptic mange (zaradi sarcoptes scabiei var. canis), demodicosis (zaradi demodex canis),preprečevanje heartworm bolezni (l3 in l4 ličinke dirofilaria immitis),zdravljenje, ki kroži microfilariae (dirofilaria immitis),zdravljenje kožne dirofilariosis (za odrasle faze dirofilaria repens)preprečevanje kožne dirofilariosis (l3 ličinke dirofilaria repens),zmanjšanje obtoku microfilariae (dirofilaria repens),preprečevanje angiostrongylosis (l4 ličinke in nezreli odraslimi angiostrongylus vasorum),zdravljenje angiostrongylus vasorum in crenosoma vulpis,preprečevanje spirocercosis (spirocerca lupi),zdravljenje eucoleus (syn. capillaria) boehmi (odrasli),zdravljenje oči črv thelazia callipaeda (odrasli),zdravljenje okužb z prebavil nematodes (l4 ličinke, nezreli odraslih od toxocara canis, ancylostoma caninum in uncinaria stenocephala, odraslimi toxascaris leonina in trichuris vulpis). izdelek se lahko uporablja kot del strategije zdravljenja alergijskega dermatitisa bolh (fad). catsfor mačke, ki trpijo ali na tveganje, mešani parazitske okužbe:zdravljenje in preprečevanje bolh okužbe (ctenocephalides felis),zdravljenje uho tropilaelaps okužbe (otodectes cynotis),zdravljenje notoedric mange (notoedres cati),zdravljenje lungworm eucoleus aerophilus (syn. capillaria aerophila) (odrasli),preprečevanje lungworm bolezni (l3/l4 ličinke aelurostrongylus abstrusus),zdravljenje lungworm aelurostrongylus abstrusus (odrasli),zdravljenje oči črv thelazia callipaeda (odrasli),preprečevanje heartworm bolezni (l3 in l4 ličinke dirofilaria immitis),zdravljenje okužb z prebavil nematodes (l4 ličinke, nezreli odraslih od toxocara cati in ancylostoma tubaeforme). izdelek se lahko uporablja kot del strategije zdravljenja alergijskega dermatitisa bolh (fad). ferretsfor bele dihurje, ki trpijo ali na tveganje, mešani parazitske okužbe:zdravljenje in preprečevanje bolh okužbe (ctenocephalides felis),preprečevanje heartworm bolezni (l3 in l4 ličinke dirofilaria immitis).

Den europeiske union - slovensk - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - imunosupresivi - prosimo, glejte dokument o izdelku.

Den europeiske union - slovensk - EMA (European Medicines Agency)

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. glej poglavja 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Den europeiske union - slovensk - 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. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni. .

Den europeiske union - slovensk - 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. učinek imatinib na izid presaditev kostnega mozga, ni bilo določeno. 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. izkušnje z imatinib pri bolnikih z mds/mpd, povezanih z pdgfr gena ponovno ureditev je zelo omejena. ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Den europeiske union - slovensk - 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 primerna za zdravljenje ofadult in pediatričnih bolnikih, ki so na novo zboleli za philadelphia kromosom (bcr‑abl) pozitivna (ph+) kronično mieloično levkemijo (cml), za katere presaditev kostnega mozga, se ne šteje kot prva linija zdravljenja. odraslih in pediatričnih bolnikih s ph+ cml v kronični fazi po izpadu interferon‑alfa terapije, ali v pospešeni fazi ali pišu krize. odraslih in pediatričnih bolnikih, ki so na novo zboleli za philadelphia kromosom pozitivno acute lymphoblastic levkemijo (ph+ all), ki je integriran z kemoterapijo. odraslih bolnikih z relapsed ali ognjevzdržni ph+ all, kot monotherapy. odraslih bolnikih z myelodysplastic/myeloproliferative bolezni (mds/mpd), ki je povezana z trombocitov, pridobljenih iz rastni dejavnik receptorjev (pdgfr) gena ponovno ureditev. za odrasle bolnike z napredovalim hypereosinophilic sindromom (hes) in/ali kronično eozinofilno levkemijo (cel) z fip1l1-pdgfra preureditev. učinek imatinib na izid presaditev kostnega mozga, ni bilo določeno. 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. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment. 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. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Den europeiske union - slovensk - EMA (European Medicines Agency)

virbac s.a. - deslorelin acetat - hipofize in hipotalamični hormoni in analogi - dogs; ferrets - za uvajanje začasne neplodnosti pri zdravih, celovitih, spolno zrelih moških psov in belih dihurjev.

Den europeiske union - slovensk - EMA (European Medicines Agency)

zoetis belgium sa - dibotermin alfa - morfogenetski proteini kosti - psi - osteoinduktivno sredstvo za uporabo pri zdravljenju zlomov z dolgimi kostmi kot dodatka k standardni kirurški posegi z uporabo zmanjšane odpovedi zlomov pri psih.

Den europeiske union - slovensk - EMA (European Medicines Agency)

ceva-phylaxia co. ltd. - celični rekombinantni herpesvirus rekombinantnega herpesa (rhvt / nd), ki eksprimira fuzijski protein virusa bolezni atipične kokošje d-26 lentogeni sev - immunologicals za aves, Živo virusna cepiva - chicken; embryonated eggs - za aktivno imunizacijo dne 18. dan-stare embryonated kokošja jajca ali en dan starih piščancev za zmanjšanje umrljivosti in kliničnih znakov, ki jih povzroča virus atipične kokošje in zmanjšanje umrljivosti, klinični znaki in poškodb, ki jih povzročajo marek je bolezen, virus z fenotip "sovražno".