欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - antineoplastic agents - hepatocellular carcinomasorafenib accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1).renal cell carcinomasorafenib accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulants, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4.2).paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.2).

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. aripiprazole accord is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. aripiprazole accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.,

欧州連合 - 英語 - 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 5.1). except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.  

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - palonosetron - vomiting; nausea; cancer - antiemetics and antinauseants, - palonosetron accord is indicated in adults for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.palonosetron accord is indicated in paediatric patients 1 month of age and older for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - zoledronic acid monohydrate - hypercalcemia; fractures, bone; cancer - bisphosphonates - prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.treatment of adult patients with tumour-induced hypercalcaemia (tih).

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - teriflunomide - multiple sclerosis, relapsing-remitting - immunosuppressants, selective immunosuppressants - teriflunomide accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5.1 for important information on the population for which efficacy has been established).

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - prostatic neoplasms - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer.for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - tigecycline - soft tissue infections; intraabdominal infections; bacterial infections; skin diseases, infectious - antibacterials for systemic use, - tygecycline accord is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1):complicated skin and soft tissue infections (cssti), excluding diabetic foot infections (see section 4.4)complicated intra-abdominal infections (ciai)tygecycline accord should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1).consideration should be given to official guidance on the appropriate use of antibacterial agents.

欧州連合 - 英語 - EMA (European Medicines Agency)

accord healthcare s.l.u. - fampridine - multiple sclerosis - other nervous system drugs - fampridine accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (edss 4-7).