European Union - English - EMA (European Medicines Agency)

csl behring gmbh - human normal immunoglobulin (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - immune sera and immunoglobulins, - replacement therapy in adults, and children and adolescents (0-18 years) in:primary immunodeficiency (pid) 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;hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (hsct);congenital aids with recurrent bacterial infections.immunomodulation in adults, and 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;chronic inflammatory demyelinating polyneuropathy (cidp). only limited experience is available of use of intravenous immunoglobulins in children with cidp.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: glycine; water for injections - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: water for injections; glycine - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: glycine; water for injections - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: water for injections; glycine - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: glycine; water for injections - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - tafamidis as meglumine - capsules soft gelatin - tafamidis as meglumine 12.2 mg - tafamidis - for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment.

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

galactoarabinan polyglucoronic acid crosspolymer -

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - carbidopa as monohydrate; levodopa - gel - levodopa 20 mg/ml; carbidopa as monohydrate 5 mg/ml - levodopa - levodopa - treatment of advanced levodopa-responsive parkinson's disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of parkinson medicinal products have not given satisfactory results.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 40 g - injection, solution - excipient ingredients: water for injections; proline - replacement therapy for primary immunodeficiency diseases (pid), myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy for idiopathic thrombocytopenic purpura (itp) in patients at high risk of bleeding or prior to surgery to correct the platelet count, guillain-barr syndrome (gbs), kawasaki disease, chronic inflammatory demyelinating polyneuropathy (cidp), multifocal motor neuropathy (mmn), myasthenia gravis (mg) exacerbations, lambert-eaton myasthenic syndrome (lems), stiff person syndrome (sps).