Onsenal Union européenne - français - EMA (European Medicines Agency)

onsenal

pfizer limited - le célécoxib - colpos de polypose adénomateuse - agents antinéoplasiques - onsenal est indiqué pour la réduction du nombre de polypes intestinaux adénomateux dans la polypose adénomateuse familiale (fap), en complément de la chirurgie et de la surveillance endoscopique ultérieure (voir section 4).. l'effet de onsenal induit une réduction de polype charge sur le risque de cancer de l'intestin n'a pas été démontrée (voir les sections 4. 4 et 5.

Constella Union européenne - français - EMA (European Medicines Agency)

constella

abbvie deutschland gmbh & co. kg - linaclotide - syndrome de l'intestin irritable - les médicaments pour la constipation - constella est indiqué pour le traitement symptomatique du syndrome du côlon irritable modéré à sévère avec constipation (ibs-c) chez les adultes.

Sialanar Union européenne - français - EMA (European Medicines Agency)

sialanar

proveca pharma limited - bromure de glycopyrronium - sialorrhée - médicaments pour troubles gastro-intestinaux fonctionnels - traitement symptomatique des grave sialorrhoea (baver pathologiques chroniques) chez les enfants et adolescents âgés de 3 ans et plus atteints de troubles neurologiques chroniques.

Truberzi Union européenne - français - EMA (European Medicines Agency)

truberzi

allergan pharmaceuticals international limited - eluxadoline - irritable bowel syndrome; diarrhea - antidiarrheals, intestinale inflammatoire / antiinfective agents - truberzi est indiqué chez les adultes pour le traitement du syndrome du côlon irritable avec diarrhée (ibs d).

Imatinib Accord Union européenne - français - EMA (European Medicines Agency)

imatinib accord

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. .