Convenia Uniunea Europeană - română - EMA (European Medicines Agency)

convenia

zoetis belgium sa - cefovecin (as sodium salt) - antibacteriene pentru uz sistemic - dogs; cats - dogsfor tratamentul pielii și țesuturilor moi infecții, inclusiv piodermite, răni și abcese asociate cu staphylococcus pseudintermedius, β-hemolitice streptococi, escherichia coli și / sau pasteurella multocida. pentru tratamentul de infecțiile urinare asociate cu escherichia coli și / sau proteus spp. ca tratament adjuvant la terapia parodontală mecanică sau chirurgicală în tratamentul infecțiilor severe ale țesuturilor gingivale și parodontale asociate cu porphyromonas spp. și prevotella spp. catsfor tratamentul pielii și țesuturilor moi abcese și răni asociate cu pasteurella multocida, usobacterium spp. , bacteroides spp. , prevotella oralis, β-hemolitice streptococi și / sau staphylococcus pseudintermedius. pentru tratamentul infecțiilor tractului urinar asociate cu escherichia coli.

Imatinib Actavis Uniunea Europeană - română - 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. , efectul de imatinib pe rezultatul de transplantul de măduvă osoasă nu a fost determinată. 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. experiența cu imatinib la pacienții cu mds/mpd asociate cu genei fcdp-re-aranjamente este foarte limitat. nu există studii controlate care să demonstreze un beneficiu clinic sau a crescut de supraviețuire pentru aceste boli.