Israel - English - Ministry of Health

medici medical ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 0.5 g / 10 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in: primary immunodeficiency syndromes such as:- congenital agammaglobulinaemia and hypogammaglobulinaemia- common variable immunodeficiency- severe combined immunodeficiency- wiskott aldrich syndromemyeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.children with congenital aids and recurrent infections.immunomodulation :idiopathic thrombocytopenic purpura (itp), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.guillain barré syndrome.kawasaki disease.allogeneic bone marrow transplantation

Israel - English - Ministry of Health

kamada ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 5 g / 100 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, and children and adolescents in:- primary immunodeficiency syndromes with impaired antibody production - hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed- hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation- congenital aids with recurrent bacterial infectionsimmunomodulation in adults, and children and adolescents in:- primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count- guillain barré syndrome- kawasaki disease

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human plasma protein >90% gamma globulin - powder and solvent for solution for infusion - 0.5 g/30 m gram(s)/millilitre - immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm. - immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration - primary immunodeficiency syndromes (pid): congenital agammaglobulinaemia and hypogammaglobulinaemia common variable immunodeficiencies severe combined immunodeficiencies wiskott aldrich syndrome myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections children with congenital aids and recurrent infections

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

octapharma australia pty ltd - human immunoglobulin g, quantity: 100 mg/ml - injection - excipient ingredients: octoxinol 10; maltose; tributyl phosphate; water for injections; human immunoglobulin a - replacement therapy in: primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. children with congenital acquired immune deficiency syndrome (aids) who have repeated bacterial infections; immunomodulation: idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. guillain barre syndrome. kawasaki disease. allogeneic bone marrow transplantation.

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

octapharma australia pty ltd - human immunoglobulin g, quantity: 100 mg/ml - injection - excipient ingredients: maltose; octoxinol 10; tributyl phosphate; water for injections; human immunoglobulin a - replacement therapy in: primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. children with congenital acquired immune deficiency syndrome (aids) who have repeated bacterial infections; immunomodulation: idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. guillain barre syndrome. kawasaki disease. allogeneic bone marrow transplantation.

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

octapharma australia pty ltd - human immunoglobulin g, quantity: 100 mg/ml - injection - excipient ingredients: tributyl phosphate; maltose; octoxinol 10; water for injections; human immunoglobulin a - replacement therapy in: primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. children with congenital acquired immune deficiency syndrome (aids) who have repeated bacterial infections; immunomodulation: idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. guillain barre syndrome. kawasaki disease. allogeneic bone marrow transplantation.

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

octapharma australia pty ltd - human immunoglobulin g, quantity: 100 mg/ml - injection - excipient ingredients: octoxinol 10; maltose; tributyl phosphate; water for injections; human immunoglobulin a - replacement therapy in: primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. children with congenital acquired immune deficiency syndrome (aids) who have repeated bacterial infections; immunomodulation: idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. guillain barre syndrome. kawasaki disease. allogeneic bone marrow transplantation.

European Union - English - EMA (European Medicines Agency)

instituto grifols s.a. - human normal immunoglobulin - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - immune sera and immunoglobulins, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 50 mg/ml - injection, intravenous infusion - excipient ingredients: human immunoglobulin a; water for injections; sorbitol - replacement therapy in: primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency, wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; and children with congenital aids and recurrent infections. immunomodulation: idiopathic thrombocytopenia purpura (itp), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count, guillian barre syndrome. allogenic bone marrow transplantation.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 50 mg/ml - injection, intravenous infusion - excipient ingredients: human immunoglobulin a; sorbitol; water for injections - replacement therapy in: primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiency, wiskott aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; and children with congenital aids and recurrent infections. immunomodulation: idiopathic thrombocytopenia purpura (itp), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count, guillian barre syndrome. allogenic bone marrow transplantation.