Malta - inglés - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - powder and solvent for solution for infusion - human plasma protein 9-14 g - blood substitutes and perfusion solutions

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

grifols australia pty ltd - alpha-1-proteinase inhibitor, quantity: 1000 mg - diluent, not applicable - excipient ingredients: - prolastin-c is an alpha-1-proteinase inhibitor (human, alpha1-pi) indicated to increase serum alpha1-pi levels in adults with congenital deficiency of alpha-1 antitrypsin and with clinically significant emphysema (fev1 less than 80%). the data for clinical efficacy of prolastin-c is derived from changes in the biomarkers alpha-1 anti-protease level and ct lung density. efficacy on fev1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials. clinical trials have only included patients who were not smoking.

Israel - inglés - Ministry of Health

omrix biopharmaceuticals - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 50 mg/ml mg/ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy * primary immunodeficiency (patients with primary defective antibody synthesis such as agammaglobulinemia or hypogammaglobulinemia) * myeloma or chronic lymphocytic leukemia (cll) with severe secondary hypogammaglobulinemia and recurrent infections. * children with congenital aids and recurrent infections - immunomodulation * idiopathic thrombocytopenic purpura (itp) * guillain barre syndrome * kawasaki disease - allogenic bone marrow transplantation

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - immunoglobulin g 160 mg/ml (immunoglobulin ex nz 16% igg) - solution for injection - 160 mg/ml - active: immunoglobulin g 160 mg/ml (immunoglobulin ex nz 16% igg) excipient: glycine - normal immunoglobulin-vf is indicated in the management of congenital and acquired forms of primary hypogammaglobulinaemia. it may also be of value in treating secondary forms of this disorder as in leukaemia, nephrosis and acute protein-losing enteropathy, particularly when there is a tendency to recurrent infection. in susceptible contacts of hepatitis a, measles and poliomyelitis, normal immunoglobulin-vf may be of value in preventing or modifying the disease. in general, the earlier in the incubation period of these diseases normal immunoglobulin-vf is given, the greater its effectiveness.

Israel - inglés - Ministry of Health

kamada ltd, israel - human plasma coagulation factor viii - powder for solution for injection - human plasma coagulation factor viii 50 iu/ml - coagulation factor viii - coagulation factor viii - treatment and prophylaxis of bleeding: in patients with haemophilia a (congenital factor viii deficiency) in patient with acquired factor viii deficiency. haemoctin is not effective in controlling the bleeding of patients with von willebrond`s disease.

Israel - inglés - Ministry of Health

kamada ltd, israel - human plasma coagulation factor viii - powder and solvent for solution for injection - human plasma coagulation factor viii 50 iu/ml - coagulation factor viii - coagulation factor viii - treatment and prophylaxis of bleeding: in patients with haemophilia a (congenital factor viii deficiency) in patient with acquired factor viii deficiency.haemoctin is not effective in controlling the bleeding of patients with von willebrond`s disease.

Israel - inglés - Ministry of Health

kamada ltd, israel - human plasma coagulation factor viii - powder and solvent for solution for injection - human plasma coagulation factor viii 100 iu/ml - coagulation factor viii - coagulation factor viii - treatment and prophylaxis of bleeding: in patients with haemophilia a (congenital factor viii deficiency) in patient with acquired factor viii deficiency.haemoctin is not effective in controlling the bleeding of patients with von willebrond`s disease.

Israel - inglés - 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

Irlanda - inglés - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human plasma protein >90% gamma globulin - solution for injection - 0.8g/5ml %w/v

Singapur - inglés - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - human hepatitis b immunoglobulin in 50mg/ml human plasma protein (igg ≥ 96%) - infusion, solution - 50 iu/ml - human hepatitis b immunoglobulin in 50mg/ml human plasma protein (igg ≥ 96%) 50 iu/ml