Schweiz - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - imatinibum - filmtabletten (teilbar) - imatinibum 400 mg bis imatinibi mesilas, cellulosum microcristallinum, crospovidonum, hypromellosum, silica colloidalis anhydrica, magnesium stearas, Überzug: macrogolum 4000, talkum, hypromellosum, e 172 (rot) e 172 (gelb), für compresso dunst. - onkologikum - synthetika

Schweiz - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

sandoz pharmaceuticals ag - imatinibum - filmtabletten - imatinibum 100 mg ut imatinibi mesilas, cellulosum microcristallinum, crospovidonum, hypromellosum, magnesii stearas, silica colloidalis anhydrica, Überzug: hypromellosum, macrogolum 4000, talcum, e 172 (flavum), e 172 (rubrum), pro compresso obducto. - zytostatikum - synthetika

Schweiz - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

sandoz pharmaceuticals ag - imatinibum - filmtabletten - imatinibum 400 mg ut imatinibi mesilas, cellulosum microcristallinum, crospovidonum, hypromellosum, magnesii stearas, silica colloidalis anhydrica, Überzug: hypromellosum, macrogolum 4000, talcum, e 172 (flavum), e 172 (rubrum), pro compresso obducto. - zytostatikum - synthetika

Schweiz - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

teva pharma ag - imatinibum - filmtabletten - imatinibum 100 mg ut imatinibi mesilas, calcii hydrogenophosphas, crospovidonum, magnesii stearas, Überzug: poly(alcohol vinylicus), macrogolum 3350, talcum, e 171, e 172 (rubrum), e 172 (flavum), pro compresso obducto. - onkologikum - synthetika

Schweiz - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

teva pharma ag - imatinibum - filmtabletten - imatinibum 400 mg ut imatinibi mesilas, calcii hydrogenophosphas, crospovidonum, magnesii stearas, Überzug: poly(alcohol vinylicus), macrogolum 3350, talcum, e 171, e 172 (rubrum), e 172 (flavum), pro compresso obducto. - onkologikum - synthetika

Schweiz - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

accord healthcare ag - imatinibum - filmtabletten - imatinibum 100 mg zu imatinibi mesilas, hypromellosum, cellulosum microcristallinum, crospovidonum, silica colloidalis anhydrica, magnesium stearas, Überzug: hypromellosum, talkum, macrogolum 8000, e 172 (gelb), e 172 (rot), für compresso dunst. - zytostatikum; ph+ chronische myeloische leukämie (ph+cml); ph+ akute lymphatische leukämie (ph+all); hypereosinophilensyndrom (hes); atypische myelodysplastische/myeloproliferative erkrankungen (mds/mpd); aggressive systemische mastozytose (sm); dermatofibrosarkom protuberans (dfsp); (für genaue angaben zur indikation siehe aktuelle fachinformation) - synthetika

Schweiz - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

accord healthcare ag - imatinibum - filmtabletten - imatinibum 400 mg bis imatinibi mesilas, hypromellosum, cellulosum microcristallinum, crospovidonum, silica colloidalis anhydrica, magnesium stearas, Überzug: hypromellosum, talkum, macrogolum 8000, e 172 (gelb), e 172 (rot), für compresso dunst. - zytostatikum; ph+ chronische myeloische leukämie (ph+cml); ph+ akute lymphatische leukämie (ph+all); hypereosinophilensyndrom (hes); atypische myelodysplastische/myeloproliferative erkrankungen (mds/mpd); aggressive systemische mastozytose (sm); dermatofibrosarkom protuberans (dfsp); (für genaue angaben zur indikation siehe aktuelle fachinformation) - synthetika

Schweiz - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

sandoz pharmaceuticals ag - imatinibum - filmtalbetten - imatinibum 100 mg zu imatinibi mesilas, cellulosum microcristallinum, crospovidonum, hypromellosum, silica colloidalis anhydrica, magnesium stearas, Überzug: macrogolum 4000, talkum, hypromellosum, e 172 (rot) e 172 (gelb), für compresso dunst. - onkologikum - synthetika

Schweiz - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

sandoz pharmaceuticals ag - imatinibum - filmtalbetten - imatinibum 400 mg bis imatinibi mesilas, cellulosum microcristallinum, crospovidonum, hypromellosum, silica colloidalis anhydrica, magnesium stearas, Überzug: macrogolum 4000, talkum, hypromellosum, e 172 (rot) e 172 (gelb), für compresso dunst. - onkologikum - synthetika

Den Europæiske Union - tysk - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastische mittel - 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. patienten, die einen niedrigen oder sehr niedrigen rückfallrisiko sollten nicht erhalten eine adjuvante behandlung. 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. außer bei patienten mit neu diagnostiziertem chronischen phase der cml gibt es keine kontrollierten studien zeigen einen klinischen nutzen oder erhöhte überlebenschancen für diese krankheiten.