United States - English - NLM (National Library of Medicine)

swedish orphan biovitrum ab (publ) - palifermin (unii: qms40680k6) (palifermin - unii:qms40680k6) - palifermin 6.25 mg in 1.2 ml - kepivance is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ who grade 3 mucositis in the majority of patients. kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ who grade 3 mucositis in the majority of patients. the safety and efficacy of kepivance have not been established in patients with non-hematologic malignancies )]. the safety and efficacy of kepivance have not been established in patients with non-hematologic malignancies

European Union - English - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - palifermin - mucositis - all other therapeutic products - kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous-haematopoietic-stem-cell support.

Canada - English - Health Canada

swedish orphan biovitrum ab (publ) - palifermin - powder for solution - 6.25mg - palifermin 6.25mg - cell stimulants and proliferants

Australia - English - Department of Health (Therapeutic Goods Administration)

a menarini australia pty ltd - palifermin -

Israel - English - Ministry of Health

megapharm ltd - palifermin 6.25 mg/vial - solution for injection - palifermin - kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in patients with haematological malignancies receiving myeloablative therapy associated with a high incidence of severe mucositis and requiring autologous haemopoietic stem cell support.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

swedish orphan biovitrum ltd - palifermin - powder for solution for injection - 6.25mg

Singapore - English - HSA (Health Sciences Authority)

singapore pharmaceutical private limited - chlorpheniramine maleate - tablet - 4 mg - chlorpheniramine maleate 4 mg

Philippines - English - FDA (Food And Drug Administration)

steinbach products, inc.; distributor: steinbach products, inc. - ampicillin (as sodium) - powder for injection (im/iv) - 250mg

Philippines - English - FDA (Food And Drug Administration)

steinbach products inc - ampicillin (as sodium) - powder for injection im / iv - 1g

Philippines - English - FDA (Food And Drug Administration)

steinbach products, inc.; distributor: steinbach products, inc. - ampicillin (as sodium) - powder for injection (im/iv) - 500mg