Imatinib Accord Unjoni Ewropea - Grieg - EMA (European Medicines Agency)

imatinib accord

accord healthcare s.l.u. - το imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - το 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. Εκτός από τη νεοδιαγνωσθείσα ΧΜΛ σε χρόνια φάση, δεν υπάρχουν ελεγχόμενες μελέτες που να καταδεικνύουν κλινικό όφελος ή αυξημένη επιβίωση για αυτές τις ασθένειες. .

CITRAFLEET PD.ORA.SOL (0.01+3.50+10.97)G/SACHET Greċja - Grieg - Εθνικός Οργανισμός Φαρμάκων

citrafleet pd.ora.sol (0.01+3.50+10.97)g/sachet

casen recordati s.l., zaragoza, spain autovia de logrono km. 13,300, 50180 zaragoza - sodium picosulfate; magnesium oxide light; citric acid - pd.ora.sol (ΚΟΝΙΣ ΓΙΑ ΠΟΣΙΜΟ ΔΙΑΛΥΜΑ) - (0.01+3.50+10.97)g/sachet - sodium picosulfate 0,01g; magnesium oxide light 3,5g; citric acid 10,97g - sodium picosulfate, combinations

PHOSPHO-SODA ORAL.SOL (24,4+10,8)G/45ML Greċja - Grieg - Εθνικός Οργανισμός Φαρμάκων

phospho-soda oral.sol (24,4+10,8)g/45ml

casen recordati s.l., zaragoza, spain autovia de logrono km. 13,300, 50180 zaragoza - sodium phosphate dibasic dodecahydrate; monobasic sodium phosphate dihydrate - oral.sol (ΠΟΣΙΜΟ ΔΙΑΛΥΜΑ) - (24,4+10,8)g/45ml - sodium phosphate dibasic dodecahydrate 240,4mg; monobasic sodium phosphate dihydrate 542,6mg - osmotically acting laxatives

CITRAFLEET POWDER FOR ORAL SOLUTION Ċipru - Grieg - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

citrafleet powder for oral solution

casen recordati sl (0000003744) autovia de logrono km 13,300, utebo-zaragoza, 50180 - sodium picosulfate; magnesium oxide light; citric acid - powder for oral solution - sodium picosulfate (0010040456) 10mg; magnesium oxide light (8000003566) 3,5g; citric acid (0000077929) 10,97g - sodium picosulfate, combinations

CITRAFLEET® ORAL.SOL (0.01+3.5+10.97)G/DOSE Greċja - Grieg - Εθνικός Οργανισμός Φαρμάκων

citrafleet® oral.sol (0.01+3.5+10.97)g/dose

casen recordati s.l., zaragoza, spain autovia de logrono km. 13,300, 50180 zaragoza - sodium picosulfate; magnesium oxide light; citric acid - oral.sol (ΠΟΣΙΜΟ ΔΙΑΛΥΜΑ) - (0.01+3.5+10.97)g/dose - sodium picosulfate 0,01g; magnesium oxide light 3,5g; citric acid 10,97g - sodium picosulfate, combinations

MEIACT 200MG/TAB F.C.TAB Greċja - Grieg - Εθνικός Οργανισμός Φαρμάκων

meiact 200mg/tab f.c.tab

tedec-meiji farma sa, madrid, spain - second-generation cephalosporins - ΕΠΙΚΑΛΥΜΕΝΟ ΜΕ ΛΕΠΤΟ ΥΜΕΝΙΟ ΔΙΣΚΙΟ - 200mg/tab - ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ - second-generation cephalosporins

MEIACT 400MG/TAB F.C.TAB Greċja - Grieg - Εθνικός Οργανισμός Φαρμάκων

meiact 400mg/tab f.c.tab

tedec-meiji farma sa, madrid, spain - second-generation cephalosporins - ΕΠΙΚΑΛΥΜΕΝΟ ΜΕ ΛΕΠΤΟ ΥΜΕΝΙΟ ΔΙΣΚΙΟ - 400mg/tab - ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ - second-generation cephalosporins

LOSEC GR.CAP 20MG/CAP Greċja - Grieg - Εθνικός Οργανισμός Φαρμάκων

losec gr.cap 20mg/cap

ΦΑΡΜΑΚΕΜΠΟΡΙΚΗ Α.Ε. Πειραιώς 226,, 177 78 177 78, Ταύρος 210.3413121 - omeprazole - gr.cap (ΓΑΣΤΡΟΑΝΘΕΚΤΙΚΟ ΚΑΨΑΚΙΟ, ΣΚΛΗΡΟ) - 20mg/cap - omeprazole 20mg - omeprazole

LOSEC CAPS 20MG/CAP Greċja - Grieg - Εθνικός Οργανισμός Φαρμάκων

losec caps 20mg/cap

pharmagora Α.Ε. ΦΑΡΜΑΚΑΠΟΘΗΚΗ Θέρμη,, 57001 2310.463400 - omeprazole - caps (ΚΑΨΑΚΙΟ, ΣΚΛΗΡΟ) - 20mg/cap - omeprazole 20mg - omeprazole

LOSEC CAPS 20MG/CAP Greċja - Grieg - Εθνικός Οργανισμός Φαρμάκων

losec caps 20mg/cap

ΒΙΟΦΑΡΜ Α.Ε. 28ης Οκτωβρίου 154, Δ.Ε. Αμπελοκήπων, Ν. Θεσσαλονίκης 2310.727787 - omeprazole - caps (ΚΑΨΑΚΙΟ, ΣΚΛΗΡΟ) - 20mg/cap - omeprazole 20mg - omeprazole