Union européenne - italien - EMA (European Medicines Agency)

accord healthcare s.l.u. - trastuzumab - breast neoplasms; stomach neoplasms - agenti antineoplastici - breast cancermetastatic breast cancer zercepac is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. prima della chemioterapia deve essere almeno un'antraciclina e un taxano, a meno che i pazienti non sono adatti per questi trattamenti. il recettore ormonale positivo, i pazienti devono, inoltre, hanno fallito la terapia ormonale, a meno che i pazienti non sono adatti per questi trattamenti.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. in combinazione con docetaxel per il trattamento di quei pazienti che non hanno ricevuto chemioterapia per la loro malattia metastatica. in combinazione con un inibitore dell'aromatasi per il trattamento di pazienti in post-menopausa con ormone-recettore positivo mbc, non trattati in precedenza con trastuzumab. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). dopo chirurgia, chemioterapia (neoadiuvante o adiuvante) e radioterapia (se applicabile). a seguito di chemioterapia adiuvante con doxorubicina e ciclofosfamide, in combinazione con paclitaxel o docetaxel. in combinazione con chemioterapia adiuvante composto di docetaxel e carboplatino. in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay. metastatic gastric cancer zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. accurato e convalidato metodi di dosaggio deve essere utilizzato.

Union européenne - italien - EMA (European Medicines Agency)

roche registration gmbh - pertuzumab, trastuzumab - neoplasie al seno - agenti antineoplastici - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Union européenne - italien - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilato - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - agenti antineoplastici - imatinib koanaa is indicated for the treatment ofadult 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. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa 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.

Union européenne - italien - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - neoplasie prostatiche - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Suisse - italien - Swissmedic (Swiss Agency for Therapeutic Products)

bavarian nordic berna gmbh - toxoidum diphtheriae, toxoidum tetani - sospensione iniettabile - toxoidum diphtheriae min. 30 u.i., toxoidum tetani min. 40 u.i., adjuvans: aluminium ut aluminii phosphatis liquamen, natrii chloridum, natrii acetas trihydricus, natrii carbonas, aqua ad iniectabile q.s. ad suspensionem pro 0.5 ml corresp. natrium 2.10 mg. - immunizzazione attiva contro difterite e tetano, a partire dalla nascita fino alla 8. compleanno - vaccini

Suisse - italien - Swissmedic (Swiss Agency for Therapeutic Products)

paxvax berna gmbh - haemagglutininum influenzae a (h1n1), neuraminidasum inactivatum (virus-stamm a/michigan/45/2015 (h1n1)-like: reassortant virus ivr-180 derived from a/singapore/gp1908/2015), haemagglutininum influenzae a (h3n2), haemagglutininum influenzae b - injektionssuspension - haemagglutininum influenzae a (h1n1) 15 µg et neuraminidasum inactivatum (virus-stamm a/michigan/45/2015 (h1n1)-like: reassortant virus ivr-180 derived from a/singapore/gp1908/2015), haemagglutininum influenzae a (h3n2) 15 µg et neuraminidasum inactivatum (virus-stamm a/hong kong/4801/2014 (h3n2)-like: reassortant virus nymc x-263b), haemagglutininum influenzae b 15 µg et neuraminidasum inactivatum (virus-stamm b/brisbane/60/2008), adjuvans mf59: squalenum, polysorbatum 80, sorbitani trioleas, natrii citras dihydricus, acidum citricum, excipiens: natrii chloridum, kalii chloridum, kalii dihydrogenophosphas, dinatrii phosphas dihydricus, magnesii chloridum hexahydricum, calcii chloridum dihydricum, aqua ad iniectabilia q.s. ad suspensionem pro 0.5 ml. - aktive immunisierung gegen influenza für ältere menschen (65 jahre oder älter), besonders für personen mit erhöhtem risiko für influenza-assoziierte komplikationen - impfstoffe

Suisse - italien - Swissmedic (Swiss Agency for Therapeutic Products)

pfizer ag - polysaccharida streptococci pneumoniae typus 1 conjugata cum proteino corynebacteriae diphtheriae crm 197, polysaccharida streptococci pneumoniae typus 3 conjugata cum proteino corynebacteriae diphtheriae crm 197, polysaccharida streptococci pneumoniae typus 4 conjugata cum proteino corynebacteriae diphtheriae crm 197, polysaccharida streptococci pneumoniae typus 5 conjugata cum proteino corynebacteriae diphtheriae crm 197, polysaccharida streptococci pneumoniae typus 6a conjugata cum proteino corynebacteriae diphtheriae crm 197, polysaccharida streptococci pneumoniae typus 6b conjugata cum proteino corynebacteriae diphtheriae crm 197, polysaccharida streptococci pneumoniae typus 7f conjugata cum proteino corynebacteriae diphtheriae crm 197, polysaccharida streptococci pneumoniae typus 9v conjugata cum proteino corynebacteriae diphtheriae crm 197, polysaccharida streptococci pneumoniae typus 14 conjugata cum proteino corynebacteriae diphtheriae crm 197, polysaccharida streptococci pneumoniae typus 18c conjugata cum proteino corynebacteriae diphtheriae crm 197, polysaccharida streptococci pneumoniae typus 19a conjugata cum proteino corynebacteriae diphtheriae crm 197, polysaccharida streptococci pneumoniae typus 19f conjugata cum proteino corynebacteriae diphtheriae crm 197, polysaccharida streptococci pneumoniae typus 23f conjugata cum proteino corynebacteriae diphtheriae crm 197 - sospensione iniettabile in una siringa preriempita - polysaccharida streptococci pneumoniae typus 1 conjugata cum proteino corynebacteriae diphtheriae crm 197 2.2 µg et polysaccharida streptococci pneumoniae typus 3 conjugata cum proteino corynebacteriae diphtheriae crm 197 2.2 µg et polysaccharida streptococci pneumoniae typus 4 conjugata cum proteino corynebacteriae diphtheriae crm 197 2.2 µg et polysaccharida streptococci pneumoniae typus 5 conjugata cum proteino corynebacteriae diphtheriae crm 197 2.2 µg et polysaccharida streptococci pneumoniae typus 6a conjugata cum proteino corynebacteriae diphtheriae crm 197 2.2 µg et polysaccharida streptococci pneumoniae typus 6b conjugata cum proteino corynebacteriae diphtheriae crm 197 4.4 µg et polysaccharida streptococci pneumoniae typus 7f conjugata cum proteino corynebacteriae diphtheriae crm 197 2.2 µg et polysaccharida streptococci pneumoniae typus 9v conjugata cum proteino corynebacteriae diphtheriae crm 197 2.2 µg et polysaccharida streptococci pneumoniae typus 14 conjugata cum proteino corynebacteriae diphtheriae crm 197 2.2 µg et polysaccharida streptococci pneumoniae typus 18c conjugata cum proteino corynebacteriae diphtheriae crm 197 2.2 µg et polysaccharida streptococci pneumoniae typus 19a conjugata cum proteino corynebacteriae diphtheriae crm 197 2.2 µg et polysaccharida streptococci pneumoniae typus 19f conjugata cum proteino corynebacteriae diphtheriae crm 197 2.2 µg et polysaccharida streptococci pneumoniae typus 23f conjugata cum proteino corynebacteriae diphtheriae crm 197 2.2 µg corresp. polysaccharida 30.8 µg et proteinum corynebacteriae diphtheriae crm 197 ca. 32 µg, adjuvans: aluminium ut aluminii phosphas, natrii chloridum corresp. natrium 1.67 mg, acidum succinicum, polysorbatum 80, aqua ad iniectabile q.s. ad suspensionem pro 0.5 ml. - aktive immunisierung gegen pneumokokken-infektionen der serotypen 1, 3, 4, 5, 6a, 6b, 7f, 9v, 14, 18c, 19a, 19f, 23f - vaccini

Suisse - italien - Swissmedic (Swiss Agency for Therapeutic Products)

emergent biosolutions berna gmbh - haemagglutininum influenzae di tipo a (h1n1), neuraminidasum inactivatum (virus-stamm a/california/7/2009 x-179a) - siringhe preriempite - haemagglutininum influenzae di tipo a (h1n1) e neuraminidasum inactivatum (virus-stamm a/california/7/2009 x-179a) a 3,75 µg, adjuvans mf59: squalenum, polysorbatum 80, sorbitani trioleas, natrii citras dihydricus, acido citricum monohydricum, excipiens: natrii chloridum, kalii chloridum, kalii dihydrogenophosphas, dinatrii phosphas dihydricus, magnesio chloridum hexahydricum, calcio chloridum dihydricum, acqua q.s. la sospensione per 0,25 ml. - vaccino influenzale pandemico - vaccini

Suisse - italien - Swissmedic (Swiss Agency for Therapeutic Products)

emergent biosolutions berna gmbh - haemagglutininum influenzae di tipo a (h1n1), neuraminidasum inactivatum (virus-stamm a/california/7/2009 x-181) - siringa preriempita - haemagglutininum influenzae di tipo a (h1n1) e neuraminidasum inactivatum (virus-stamm a/california/7/2009 x-181) 7.5 µg, adjuvans mf59: squalenum, polysorbatum 80, sorbitani trioleas, natrii citras dihydricus, acido citricum monohydricum, excipiens: natrii chloridum, kalii chloridum, kalii dihydrogenophosphas, dinatrii phosphas dihydricus, magnesio chloridum hexahydricum, calcio chloridum dihydricum, acqua q.s. la sospensione 0,5 ml. - vaccino influenzale pandemico - vaccini

Suisse - italien - Swissmedic (Swiss Agency for Therapeutic Products)

emergent biosolutions berna gmbh - haemagglutininum influenzae di tipo a (h1n1), neuraminidasum inactivatum (virus-stamm a/california/7/2009 x-181) - mehrfachdosenbehältnis - haemagglutininum influenzae di tipo a (h1n1) e neuraminidasum inactivatum (virus-stamm a/california/7/2009 x-181) 7.5 µg, adjuvans mf59: squalenum, polysorbatum 80, sorbitani trioleas, natrii citras dihydricus, acido citricum monohydricum, excipiens: natrii chloridum, kalii chloridum, kalii dihydrogenophosphas, dinatrii phosphas dihydricus, magnesio chloridum hexahydricum, calcio chloridum dihydricum, conserv.: thiomersalum 50 µg, acqua q.s. la sospensione 0,5 ml. - vaccino influenzale pandemico - vaccini