Ευρωπαϊκή Ένωση - Γερμανικά - 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.

Ευρωπαϊκή Ένωση - Γερμανικά - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - hämoglobinurie, paroxysmal - immunsuppressiva - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). klinischer nutzen ist nachgewiesen bei patienten mit hämolyse mit klinischen symptom(s) indikativ von hoher krankheitsaktivität unabhängig von der transfusion geschichte (siehe abschnitt 5.

Ελβετία - Γερμανικά - Swissmedic (Swiss Agency for Therapeutic Products)

amgen switzerland ag - pegfilgrastimum - injektionslösung in einer fertigspritze - pegfilgrastimum 6 mg, acidum aceticum glaciale, natrii hydroxidum corresp. natrium 20.4 µg, sorbitolum 30 mg, polysorbatum 20, aqua ad iniectabile q.s. ad solutionem pro 0.6 ml. - neutropenie - biotechnologika

Ελβετία - Γερμανικά - Swissmedic (Swiss Agency for Therapeutic Products)

accord healthcare ag - pegfilgrastimum - injektionslösung in einer fertigspritze - pegfilgrastimum 6 mg, acidum aceticum glaciale, sorbitolum 30 mg, polysorbatum 20, natrii hydroxidum corresp. natrium 0.019 mg, aqua ad iniectabile, q.s. ad solutionem pro 0.6 ml. - neutropenie - biotechnologika

Ελβετία - Γερμανικά - Swissmedic (Swiss Agency for Therapeutic Products)

mundipharma medical company, hamilton, bermuda, basel branch - pegfilgrastimum - injektionslösung - pegfilgrastimum 6 mg, natrii acetas trihydricus, acidum aceticum glaciale, sorbitolum 29.4 mg, polysorbatum 20, natrii hydroxidum, acidum hydrochloridum concentratum, aqua ad iniectabile, q.s. ad solutionem pro 0.6 ml corresp. natrium 0.20 mg. - neutropenie - biotechnologika

Ελβετία - Γερμανικά - Swissmedic (Swiss Agency for Therapeutic Products)

medius ag - pegfilgrastimum - injektionslösung - pegfilgrastimum 6 mg, sorbitolum 30 mg, polysorbatum 20, acidum aceticum, natrii hydroxidum corresp. natrium, aqua ad iniectabile, q.s. ad solutionem pro 0.6 ml. - neutropenie - biotechnologika

Ελβετία - Γερμανικά - Swissmedic (Swiss Agency for Therapeutic Products)

sandoz pharmaceuticals ag - pegfilgrastimum, natrium - injektionslösung in fertigspritzen - pegfilgrastimum 6 mg, acidum aceticum, sorbitolum 30 mg, polysorbatum 20, natrii hydroxidum, aqua ad iniectabile, aqua q.s. ad solutionem pro 0.6 ml corresp. natrium 0.0074 mg. - neutropenie - biotechnologika

Ελβετία - Γερμανικά - Swissmedic (Swiss Agency for Therapeutic Products)

accord healthcare ag - pegfilgrastimum - injektionslösung in fertiginjektor - pegfilgrastimum 6 mg, acidum aceticum glaciale, sorbitolum 30 mg, polysorbatum 20, natrii hydroxidum corresp. natrium 0.019 mg, aqua ad iniectabile, q.s. ad solutionem pro 0.6 ml. - neutropenie - biotechnologika

Ελβετία - Γερμανικά - Swissmedic (Swiss Agency for Therapeutic Products)

iqone healthcare switzerland sa - pegfilgrastimum - solution injectable en seringue préremplie - pegfilgrastimum 6 mg, sorbitolum 30 mg, polysorbatum 20, natrii hydroxidum, acidum aceticum glaciale, aqua ad iniectabile ad solutionem pro 0.6 ml corresp. natrium 0.02 mg. - neutropenie - biotechnologika

Γερμανία - Γερμανικά - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

cassella - med gmbh & co. kg (3165486) - cineol - magensaftresistente weichkapsel - cineol (01537) 100 milligramm