Austrija - njemački - AGES (Agentur für Gesundheit und Ernährungssicherheit)

accord healthcare b.v. - aripiprazol -

Austrija - njemački - AGES (Agentur für Gesundheit und Ernährungssicherheit)

accord healthcare b.v. - aripiprazol -

Austrija - njemački - AGES (Agentur für Gesundheit und Ernährungssicherheit)

accord healthcare b.v. - aripiprazol -

Austrija - njemački - AGES (Agentur für Gesundheit und Ernährungssicherheit)

accord healthcare b.v. - aripiprazol -

Njemačka - njemački - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

accord healthcare b.v. (8182087) - bisoprololfumarat (ph.eur.) - filmtablette - 2,5 mg - teil 1 - filmtablette; bisoprololfumarat (ph.eur.) (23549) 2,5 milligramm

Njemačka - njemački - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

accord healthcare b.v. (8182087) - bisoprololfumarat (ph.eur.) - filmtablette - 5 mg - teil 1 - filmtablette; bisoprololfumarat (ph.eur.) (23549) 5 milligramm

Njemačka - njemački - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

accord healthcare b.v. (8182087) - bisoprololfumarat (ph.eur.) - filmtablette - 10 mg - teil 1 - filmtablette; bisoprololfumarat (ph.eur.) (23549) 10 milligramm

Europska Unija - njemački - 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. 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. .

Europska Unija - njemački - EMA (European Medicines Agency)

accord healthcare s.l.u. - tigecyclin - soft tissue infections; intraabdominal infections; bacterial infections; skin diseases, infectious - antibiotika für den systemischen einsatz, - tygecycline accord ist indiziert bei erwachsenen und bei kindern ab dem alter von acht jahren für die behandlung der folgenden infektionen (siehe abschnitte 4. 4 und 5. 1):komplizierte haut-und weichteilinfektionen (cssti) ohne diabetische fuß-infektionen (siehe abschnitt 4. 4)komplizierte intraabdomineller infektionen (ciai)tygecycline accord sollte nur verwendet werden, in situationen, in denen andere alternative antibiotika nicht geeignet sind (siehe abschnitte 4. 4, 4. 8 und 5. es sollte erwogen werden, um die offiziellen richtlinien über den angemessenen gebrauch von antibakteriellen wirkstoffen.

Europska Unija - njemački - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - antineoplastische mittel - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.