Европска Унија - Италијански - EMA (European Medicines Agency)

sandoz gmbh - epoetina alfa - anemia; kidney failure, chronic - preparazioni antianemiche - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis;, treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. stato cardiovascolare, pre-esistente anemia all'inizio della chemioterapia).

Европска Унија - Италијански - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - linfoma di leucemia linfoblastica a cellule precursori - agenti antineoplastici - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Европска Унија - Италијански - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimicotici per uso sistemico - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Европска Унија - Италијански - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - infezioni da hiv - antivirali per uso sistemico - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):per il trattamento dell'infezione da hiv-1 in trattamento antiretrovirale (art) di pazienti adulti, compresi quelli che sono stati fortemente pre-trattati. per il trattamento dell'infezione da hiv-1 in pazienti pediatrici a partire dall'età di 3 anni e di almeno 15 kg di peso corporeo. nel decidere di iniziare il trattamento con o esposti per lungo tempo co-somministrato con basse dosi di ritonavir, attenta considerazione deve essere data la storia di trattamento per il singolo paziente e il tipo di mutazioni associate con diversi agenti. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 e 5. o esposti per lungo tempo co-somministrato con basse dosi di ritonavir è indicato in combinazione con altri medicinali antiretrovirali per il trattamento di pazienti con il virus dell'immunodeficienza umana (hiv-1) infezione.  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. nel decidere di iniziare il trattamento con o esposti per lungo tempo in tale arte-esperto pazienti, genotipica test devono guidare l'uso di o esposti per lungo tempo (vedere sezioni 4. 2, 4. 3, 4. 4 e 5.

Европска Унија - Италијански - EMA (European Medicines Agency)

hexal ag - epoetina alfa - anemia; kidney failure, chronic; cancer - preparazioni antianemiche - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. trattamento dell'anemia e riduzione del fabbisogno trasfusionale in pazienti adulti in chemioterapia per tumori solidi, linfoma maligno o mieloma multiplo e a rischio di trasfusione come valutato da stato generale del paziente (e. stato cardiovascolare, pre-esistente anemia all'inizio della chemioterapia).

Европска Унија - Италијански - 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 - agenti antineoplastici - 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. l'effetto di glivec sull'esito del midollo osseo trapianto non è stata determinata. 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. i pazienti che hanno un basso o bassissimo rischio di recidiva non dovrebbero ricevere il trattamento adiuvante; il trattamento dei pazienti adulti con metastasi dermatofibrosarcoma protuberans (dfsp) e in pazienti adulti con recidivante e / o metastatico dfsp che non sono eleggibili per la chirurgia. in pazienti adulti e pediatrici, l'efficacia di glivec è basato sulla complessiva ematologica e citogenetica tassi di risposta e di sopravvivenza libera da progressione in cml, ematologica e citogenetica tassi di risposta ph+, mds / mpd, su valori di risposta ematologica in hes / lec e su tassi di risposta obiettiva in pazienti adulti con operabili e / o metastatici gist e dfsp e la sopravvivenza libera da recidiva in adiuvante gist. l'esperienza con glivec in pazienti con mds / mpd associate a riarrangiamenti del gene pdgfr è molto limitata (vedere la sezione 5. tranne che nel recente diagnosi di lmc in fase cronica, non ci sono studi clinici controllati che dimostrano un beneficio clinico o un aumento della sopravvivenza per queste malattie.

Европска Унија - Италијански - EMA (European Medicines Agency)

gilead sciences ireland uc - ledipasvir, sofosbuvir - epatite c, cronica - antivirali per uso sistemico - harvoni is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 e 5. per il virus dell'epatite c (hcv) di genotipo-specifici di attività, vedere sezioni 4. 4 e 5.

Европска Унија - Италијански - 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. tranne che nel recente diagnosi di lmc in fase cronica, non ci sono studi clinici controllati che dimostrano un beneficio clinico o un aumento della sopravvivenza per queste malattie. .

Европска Унија - Италијански - 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. l'effetto di imatinib sull'esito del trapianto di midollo osseo non è stata determinata. 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. l'esperienza con imatinib in pazienti con mds/mpd associate a riarrangiamenti del gene pdgfr è molto limitata. non ci sono studi clinici controllati che dimostrano un beneficio clinico o un aumento della sopravvivenza per queste malattie.

Европска Унија - Италијански - 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 è indicato per il trattamento ofadult e pediatrici, pazienti con nuova diagnosi per il cromosoma philadelphia (bcr‑abl) positivo (ph+) di leucemia mieloide cronica (cml) per i quali il trapianto di midollo osseo non è considerato come trattamento di prima linea. pazienti adulti e pediatrici con lmc ph+ in fase cronica dopo il fallimento della terapia con interferone‑alfa, o in fase accelerata o in crisi blastica. pazienti adulti e pediatrici con nuova diagnosi di cromosoma philadelphia positivo da leucemia linfoblastica acuta (lla ph+) integrato con chemioterapia. pazienti adulti con recidiva o refrattaria ph+ in monoterapia. pazienti adulti con malattie mielodisplastiche/mieloproliferative (mds/mpd) associati con platelet-derived growth factor receptor (pdgfr) gene ri-arrangiamenti. pazienti adulti con sindrome ipereosinofila avanzata (hes) e/o con leucemia eosinofila cronica (cel) con riarrangiamento fip1l1-pdgfra riarrangiamento. l'effetto di imatinib sull'esito del trapianto di midollo osseo non è stata determinata. 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. i pazienti che hanno un basso o bassissimo rischio di recidiva non dovrebbero ricevere il trattamento adiuvante. 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. tranne che nel recente diagnosi di lmc in fase cronica, non ci sono studi clinici controllati che dimostrano un beneficio clinico o un aumento della sopravvivenza per queste malattie.