欧盟 - 英文 - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.2).,

欧盟 - 英文 - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimycotics for systemic use - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

欧盟 - 英文 - EMA (European Medicines Agency)

accord healthcare s.l.u. - caspofungin acetate - candidiasis; aspergillosis - antimycotics for systemic use - treatment of invasive candidiasis in adult or paediatric patients.treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and/or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

欧盟 - 英文 - EMA (European Medicines Agency)

janssen-cilag international n.v.   - decitabine - leukemia, myeloid - antineoplastic agents - treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (aml), according to the world health organization (who) classification, who are not candidates for standard induction chemotherapy.

欧盟 - 英文 - EMA (European Medicines Agency)

hexal ag - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.mobilisation of peripheral blood progenitor cells (pbpcs).in children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.treatment of persistent neutropenia (anc ≤ 0.5 x 109/l), and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.

欧盟 - 英文 - EMA (European Medicines Agency)

ratiopharm gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - filgrastim ratiopharm is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.filgrastim ratiopharm is indicated for the mobilisation of peripheral blood progenitor cells (pbpc).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim ratiopharm is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.filgrastim ratiopharm is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

欧盟 - 英文 - EMA (European Medicines Agency)

accord healthcare s.l.u. - filgrastim - neutropenia - immunostimulants, - grastofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of grastofil are similar in adults and children receiving cytotoxic chemotherapy.grastofil is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).in patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.grastofil is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

欧盟 - 英文 - EMA (European Medicines Agency)

sanofi pasteur msd, snc - purified diphtheria toxoid, purified tetanus toxoid, purified pertussis toxoid, purified pertussis filamentous haemagglutinin, hepatitis b surface antigen, inactivated type 1 poliovirus (mahoney), inactivated type 2 poliovirus (mef 1), inactivated type 3 poliovirus (saukett), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - this combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis b caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by haemophilus influenzae type b.

欧盟 - 英文 - EMA (European Medicines Agency)

pfizer europe ma eeig  - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤0.5 x 109/l and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.filgrastim is indicated for the treatment of persistent neutropenia (anc ≤1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

欧盟 - 英文 - EMA (European Medicines Agency)

sandoz gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.mobilisation of peripheral blood progenitor cells (pbpc).in children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.treatment of persistent neutropenia (anc ≤ 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.