Yunani - Greek - Εθνικός Οργανισμός Φαρμάκων

b. braun melsungen a.g, germany carl-braun-strasse 1, 34212 melsungen 0049 56 61 71 2849 - isoleucine; leucine; lysine hydrochloride; methionine; phenylalanine; threonine; tryptophan, l-; valine; arginine; histidine hydrochloride; alanine; aspartic acid; glutamic acid; glycine; proline; serine; sodium hydroxide; sodium chloride; sodium acetate trihydrate; potassium acetate; magnesium acetate tetrahydrate; calcium chloride dihydrate; dextrose(glucose) monohydrate; monobasic sodium phosphate dihydrate; zinc acetate dihydrate; triglycerides medium chain; soya oil; omega-3-acid triglycerides - inj.em.inf (ΓΑΛΑΚΤΩΜΑ ΓΙΑ ΕΓΧΥΣΗ) - isoleucine 1,872g; leucine 2,504g; lysine hydrochloride 2,272g; methionine 1,568g; phenylalanine 2,808g; threonine 1,456g; tryptophan, l- 0,456g; valine 2,08g; arginine 2,16g; histidine hydrochloride 1,352g; alanine 3,88g; aspartic acid 1,2g; glutamic acid 2,8g; glycine 1,32g; proline 2,72g; serine 2,4g; sodium hydroxide 0,64g; sodium chloride 0,865g; sodium acetate trihydrate 0,435g; potassium acetate 2.354g; magnesium acetate tetrahydrate 0,515g; calcium chloride dihydrate 0,353g; dextrose(glucose) monohydrate 70,4g; monobasic sodium phosphate dihydrate 0,936g; zinc acetate dihydrate 5,28g; triglycerides medium chain 20g; soya oil 16g; omega-3-acid triglycerides 4g - combinations

Kesatuan Eropah - Greek - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - Πρόδρομη κυτταρική λεμφοβλαστική λευχαιμία-λέμφωμα - Αντινεοπλασματικοί παράγοντες - 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.

Kesatuan Eropah - Greek - EMA (European Medicines Agency)

pfizer europe ma eeig - τοποτεκάνη - uterine cervical neoplasms; small cell lung carcinoma - Άλλοι αντινεοπλασματικοί παράγοντες - topotecan μονοθεραπεία ενδείκνυται για τη θεραπεία των ασθενών με υποτροπιάζουσα small cell ο καρκίνος του πνεύμονα (sclc) για τους οποίους ξανά θεραπεία με το θεραπευτικό σχήμα πρώτης γραμμής δεν θεωρείται κατάλληλη. Η τοποτεκάνη σε συνδυασμό με σισπλατίνη ενδείκνυται για ασθενείς με καρκίνωμα του τραχήλου της μήτρας επαναλαμβανόμενες μετά την ακτινοθεραπεία και για ασθενείς με νόσο σταδίου ivb. Ασθενείς με προηγούμενη έκθεση στη σισπλατίνη απαιτούν παρατεταμένη θεραπεία διάστημα χωρίς να δικαιολογούν την θεραπεία με το συνδυασμό.

Kesatuan Eropah - Greek - EMA (European Medicines Agency)

intervet international b.v. - fluralaner - Εκτοπαρτικοκτόνα, εντομοκτόνα και απωθητικά - Κοτόπουλο - Επεξεργασία της μόλυνσης από κόκκινα ακάρεα πουλερικών (dermanyssus gallinae) σε όρνιθες, εκτροφείς και όρνιθες.

Yunani - Greek - Εθνικός Οργανισμός Φαρμάκων

b. braun melsungen a.g, germany carl-braun-strasse 1, 34212 melsungen 0049 56 61 71 2849 - isoleucine; leucine; lysine hydrochloride; methionine; phenylalanine; threonine; tryptophan, l-; valine; arginine; histidine hydrochloride; alanine; glycine; aspartic acid; glutamic acid; proline; serine; sodium chloride; sodium acetate trihydrate; potassium acetate; magnesium acetate tetrahydrate; calcium chloride dihydrate; sodium hydroxide; dextrose(glucose) monohydrate; monobasic sodium phosphate dihydrate; zinc acetate dihydrate; triglycerides medium chain; soya oil; omega-3-acid triglycerides - inj.em.inf (ΓΑΛΑΚΤΩΜΑ ΓΙΑ ΕΓΧΥΣΗ) - isoleucine 5,64g; leucine 7,52g; lysine hydrochloride 6,82g; methionine 4,7g; phenylalanine 8,42g; threonine 4,36g; tryptophan, l- 1,36g; valine 6,24g; arginine 6,48g; histidine hydrochloride 4,06g; alanine 11,64g; glycine 3,96g; aspartic acid 3,6g; glutamic acid 8,42g; proline 8,16g; serine 7,2g; sodium chloride 1,006g; sodium acetate trihydrate 0,554g; potassium acetate 6,868g; magnesium acetate tetrahydrate 1,716g; calcium chloride dihydrate 1,176g; sodium hydroxide 1,952g; dextrose(glucose) monohydrate 330g; monobasic sodium phosphate dihydrate 4,68g; zinc acetate dihydrate 13,16mg; triglycerides medium chain 100g; soya oil 80g; omega-3-acid triglycerides 20g - combinations

Yunani - Greek - Εθνικός Οργανισμός Φαρμάκων

b. braun melsungen a.g, germany carl-braun-strasse 1, 34212 melsungen 0049 56 61 71 2849 - isoleucine; leucine; lysine hydrochloride; methionine; phenylalanine; threonine; tryptophan, l-; valine; arginine; histidine hydrochloride; alanine; glycine; aspartic acid; glutamic acid; proline; serine; sodium chloride; sodium acetate trihydrate; potassium acetate; magnesium acetate tetrahydrate; calcium chloride dihydrate; sodium hydroxide; dextrose(glucose) monohydrate; monobasic sodium phosphate dihydrate; zinc acetate dihydrate; triglycerides medium chain; soya oil; omega-3-acid triglycerides - inj.em.inf (ΓΑΛΑΚΤΩΜΑ ΓΙΑ ΕΓΧΥΣΗ) - isoleucine 8,21g; leucine 10,96g; lysine hydrochloride 9,95g; methionine 6,84g; phenylalanine 12,29g; threonine 6,35g; tryptophan, l- 2g; valine 9,01g; arginine 9,45g; histidine hydrochloride 5,92g; alanine 16,98g; glycine 5,78g; aspartic acid 5,25g; glutamic acid 12,27g; proline 11,9g; serine 10,5g; sodium chloride 0,946g; sodium acetate trihydrate 0,626g; potassium acetate 9,222g; magnesium acetate tetrahydrate 2,274g; calcium chloride dihydrate 1,558g; sodium hydroxide 2,928g; dextrose(glucose) monohydrate 396g; monobasic sodium phosphate dihydrate 6,24g; zinc acetate dihydrate 17,56mg; triglycerides medium chain 100g; soya oil 80g; omega-3-acid triglycerides 20g - combinations

Yunani - Greek - Εθνικός Οργανισμός Φαρμάκων

b. braun melsungen a.g, germany carl-braun-strasse 1, 34212 melsungen 0049 56 61 71 2849 - isoleucine; leucine; lysine monohydrate; methionine; phenylalanine; threonine; tryptophan, l-; valine; arginine; histidine hydrochloride; alanine; aspartic acid; glutamic acid; glycine; proline; serine; dextrose(glucose) monohydrate; triglycerides medium chain; soya oil; omega-3-acid triglycerides - inj.em.inf (ΓΑΛΑΚΤΩΜΑ ΓΙΑ ΕΓΧΥΣΗ) - isoleucine 3,284g; leucine 4,384g; lysine monohydrate 3,576g; methionine 2,736g; phenylalanine 4,196g; threonine 2,54g; tryptophan, l- 0,8g; valine 3,604g; arginine 3,78g; histidine hydrochloride 1,752g; alanine 6,792g; aspartic acid 2,1g; glutamic acid 4,908g; glycine 2,312g; proline 4,76g; serine 4,2g; dextrose(glucose) monohydrate 158,4g; triglycerides medium chain 20g; soya oil 16g; omega-3-acid triglycerides 4g - combinations

Yunani - Greek - Εθνικός Οργανισμός Φαρμάκων

fresenius kabi hellas ae Λεωφ. Κηφισίας 64Α, 151 25 Μαρούσι Αττικής 6542909 - alanine; arginine; glycine; histidine; isoleucine; leucine; lysine acetate; methionine; phenylalanine; proline; serine; taurine; threonine; tryptophan, l-; tyrosine; valine; calcium chloride dihydrate; sodium glycerophosphate; magnesium sulfate; potassium chloride; sodium acetate trihydrate; zinc sulfate heptahydrate; dextrose(glucose) monohydrate; soya bean oil, hydrogenated; triglycerides medium chain; olive oil, refined; fish oil (omega-3 polyunsaturated fatty acids) - inj.em.inf (ΓΑΛΑΚΤΩΜΑ ΓΙΑ ΕΓΧΥΣΗ) - alanine 14g; arginine 12g; glycine 11g; histidine 3g; isoleucine 5g; leucine 7,4g; lysine acetate 9,3g; methionine 4,3g; phenylalanine 5,1g; proline 11,2g; serine 6,5g; taurine 1g; threonine 4,4g; tryptophan, l- 2,2g; tyrosine 0,4g; valine 6,2g; calcium chloride dihydrate 0,434g; sodium glycerophosphate 3,48g; magnesium sulfate 0,931g; potassium chloride 3,48g; sodium acetate trihydrate 2,47g; zinc sulfate heptahydrate 0,01g; dextrose(glucose) monohydrate 462g; soya bean oil, hydrogenated 60g; triglycerides medium chain 60g; olive oil, refined 50g; fish oil (omega-3 polyunsaturated fatty acids) 30g - combinations

Yunani - Greek - Εθνικός Οργανισμός Φαρμάκων

fresenius kabi hellas ae Λεωφ. Κηφισίας 64Α, 151 25 Μαρούσι Αττικής 6542909 - dextrose(glucose) monohydrate; soya bean oil, hydrogenated; triglycerides medium chain; olive oil, refined; fish oil (omega-3 polyunsaturated fatty acids); alanine; arginine; glycine; histidine; isoleucine; leucine; lysine acetate; methionine; phenylalanine; proline; serine; taurine; threonine; tryptophan, l-; tyrosine; valine - inj.em.inf (ΓΑΛΑΚΤΩΜΑ ΓΙΑ ΕΓΧΥΣΗ) - dextrose(glucose) monohydrate 462g; soya bean oil, hydrogenated 60g; triglycerides medium chain 60g; olive oil, refined 50g; fish oil (omega-3 polyunsaturated fatty acids) 30g; alanine 9,3g; arginine 4,3g; glycine 5,1g; histidine 11,2g; isoleucine 6,5g; leucine 1g; lysine acetate 4,4g; methionine 2g; phenylalanine 0,4g; proline 6,2g; serine 0,574g; taurine 3,48g; threonine 1,92g; tryptophan, l- 3,48g; tyrosine 4,1g; valine 0,018g - combinations

Kesatuan Eropah - Greek - EMA (European Medicines Agency)

koanaa healthcare gmbh - το imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - Αντινεοπλασματικοί παράγοντες - 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. Ασθενείς χαμηλού ή πολύ χαμηλού κινδύνου της υποτροπής δεν θα πρέπει να λαμβάνουν επικουρική θεραπεία. 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. Εκτός από τη νεοδιαγνωσθείσα ΧΜΛ σε χρόνια φάση, δεν υπάρχουν ελεγχόμενες μελέτες που να καταδεικνύουν κλινικό όφελος ή αυξημένη επιβίωση για αυτές τις ασθένειες.