Uniunea Europeană - franceză - 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. sauf dans les pays nouvellement diagnostiqué en phase chronique de la lmc, il n'y a pas d'essais contrôlés à démontrer un bénéfice clinique ou l'augmentation de la survie pour ces maladies. .

Uniunea Europeană - franceză - 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'effet de l'imatinib sur les résultats de la greffe de moelle osseuse n'a pas été déterminée. 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'expérience avec de l'imatinib chez les patients atteints de smd/smp associés à pdgfr gène de ré-arrangements est très limité. il n'y a pas d'essais contrôlés à démontrer un bénéfice clinique ou l'augmentation de la survie pour ces maladies.

Uniunea Europeană - franceză - 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 est indiqué pour le traitement ofadult et de pédiatrie patients nouvellement diagnostiqués porteurs du chromosome philadelphie (bcr‑abl) positif (ph+) la leucémie myéloïde chronique (lmc), pour qui la greffe de moelle osseuse n'est pas considérée comme le traitement de première ligne. des adultes et des enfants atteints de lmc ph+ en phase chronique après échec de l'interféron‑alpha thérapie, ou dans une phase accélérée ou en crise blastique. les adultes et les patients pédiatriques ayant récemment reçu un diagnostic à chromosome philadelphie positif de leucémie aiguë lymphoblastique (ph+) intégré avec la chimiothérapie. les patients adultes en rechute ou réfractaire ph+ en monothérapie. patients adultes atteints de myélodysplasiques/myéloprolifératifs (smd/smp) associé à platelet-derived growth factor receptor (pdgfr), le gène de ré-arrangements. les patients adultes avec fonctions avancées de syndrome hyperéosinophilique (she) et/ou de leucémie chronique à éosinophiles (cel) avec fip1l1-pdgfra. l'effet de l'imatinib sur les résultats de la greffe de moelle osseuse n'a pas été déterminée. 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. les patients qui ont une faible ou très faible risque de récidive ne doit pas recevoir de traitement adjuvant. 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. sauf dans les pays nouvellement diagnostiqué en phase chronique de la lmc, il n'y a pas d'essais contrôlés à démontrer un bénéfice clinique ou l'augmentation de la survie pour ces maladies.

Elveția - franceză - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - imatinibum - gélules - imatinibum 100 mg ut imatinibi mesilas, cellulosum microcristallinum, crospovidonum, silica colloidalis anhydrica, magnesii stearas, kapselhülle: gelatina, e 171, e 172 (flavum), e 172 (rubrum), drucktinte: lacca, e 172 (rubrum), propylenglycolum, ammoniae solutio concentrata, kalii hydroxidum, pro capsula. - cytostatique (orphan drug indications):; ph+ la leucémie myéloïde chronique (lmc ph+); ph+ la leucémie aiguë lymphoblastique (lal ph+); hypereosinophilensyndrom (she/lce); atypiques myélodysplasique/troubles myéloprolifératifs (smd/smp); mastocytose systémique agressive (aggr. sm); tumeurs stromales gastro-intestinales (gist); dermatofibrosarkom protuberans (dfsp) - synthetika

Elveția - franceză - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - imatinibum - comprimés pelliculés (sécables) - imatinibum 100 mg ut imatinibi mesilas, cellulosum microcristallinum, crospovidonum, hypromellosum, silica colloidalis anhydrica, magnesii stearas, Überzug: hypromellosum, e 172 (rubrum), e 172 (flavum), macrogolum 4000, talcum, pro compresso obducto. - cytostatique; ph+ la leucémie myéloïde chronique (lmc ph+); ph+ la leucémie aiguë lymphoblastique (lal ph+); hypereosinophilensyndrom (she/lce); atypiques myelodysplastische/troubles myéloprolifératifs (smd/smp); mastocytose systémique agressive (aggr. sm); tumeurs stromales gastro-intestinales (gist); dermatofibrosarkom protuberans (dfsp); (pour plus d'informations sur l'indication, voir le résumé des caractéristiques du produit) - synthetika

Elveția - franceză - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - imatinibum - comprimés pelliculés - imatinibum 400 mg ut imatinibi mesilas, cellulosum microcristallinum, crospovidonum, hypromellosum, silica colloidalis anhydrica, magnesii stearas, Überzug: hypromellosum, e 172 (flavum), e 172 (rubrum), macrogolum 4000, talcum, pro compresso obducto. - cytostatique; ph+ la leucémie myéloïde chronique (lmc ph+); ph+ la leucémie aiguë lymphoblastique (lal ph+); hypereosinophilensyndrom (she/lce); atypiques myelodysplastische/troubles myéloprolifératifs (smd/smp); mastocytose systémique agressive (aggr. sm); tumeurs stromales gastro-intestinales (gist); dermatofibrosarkom protuberans (dfsp); (pour plus d'informations sur l'indication, voir le résumé des caractéristiques du produit) - synthetika

Elveția - franceză - Swissmedic (Swiss Agency for Therapeutic Products)

novartis pharma schweiz ag - imatinibum - comprimés pelliculés (sécables) - imatinibum 400 mg ut imatinibi mesilas, cellulosum microcristallinum, crospovidonum, hypromellosum, magnesii stearas, silica colloidalis anhydrica, Überzug: hypromellosum, e 172 (flavum), e 172 (rubrum), macrogolum 4000, talcum, pro compresso obducto. - cytostatique; ph+ la leucémie myéloïde chronique (lmc ph+); ph+ la leucémie aiguë lymphoblastique (lal ph+); hypereosinophilensyndrom (she/lce); atypiques myelodysplastische/troubles myéloprolifératifs (smd/smp); mastocytose systémique agressive (aggr. sm); tumeurs stromales gastro-intestinales (gist); dermatofibrosarkom protuberans (dfsp); (pour plus d'informations sur l'indication, voir le résumé des caractéristiques du produit) - synthetika

Elveția - franceză - Swissmedic (Swiss Agency for Therapeutic Products)

mylan pharma gmbh - imatinibum - comprimés pelliculés - imatinibum 100 mg ut imatinibi mesilas 119.5 mg, silica colloidalis anhydrica, cellulosum microcristallinum, crospovidonum, hypromellosum, magnesii stearas, Überzug: poly(alcohol vinylicus), macrogolum 3350, talcum, e 171, e 172, pro compresso obducto. - onkologikum - synthetika

Elveția - franceză - Swissmedic (Swiss Agency for Therapeutic Products)

mylan pharma gmbh - imatinibum - comprimés pelliculés - imatinibum 400 mg ut imatinibi mesilas 478 mg, silica colloidalis anhydrica, cellulosum microcristallinum, crospovidonum, hypromellosum, magnesii stearas, Überzug: poly(alcohol vinylicus), macrogolum 3350, talcum, e 171, e 172, pro compresso obducto. - onkologikum - synthetika

Elveția - franceză - Swissmedic (Swiss Agency for Therapeutic Products)

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