Ireland - English - HPRA (Health Products Regulatory Authority)

grifols deutschland gmbh - immunoglobulin human normal - solution for infusion - 100 milligram(s)/millilitre - immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - normal immunoglobulin 100 mg/ml - solution for infusion - 100 g/l - active: normal immunoglobulin 100 mg/ml excipient: glycine water for injection - replacement therapy indications: - primary immunodeficiency (pi) diseases - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: gb distributors inc.; distributor: gb distributors inc. - human normal immunoglobulin (ivig) - solution for infusion (iv/sc) - 10% (100 mg/ml)

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

grifols uk ltd - normal immunoglobulin human - solution for infusion - 100mg/1ml

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

grifols uk ltd - normal immunoglobulin human - solution for infusion - 100mg/1ml

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

grifols uk ltd - normal immunoglobulin human - solution for infusion - 100mg/1ml

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

grifols uk ltd - normal immunoglobulin human - solution for infusion - 100mg/1ml

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 0.1 g/ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - gamunex is indicated as replacement therapy of primary immunodeficiency (pi) states in which severe impaiment of antibody forming capacity has been shown, such as congential agammaglobulinemia, common variable immunodeficiency, x-limked immunodeficiency with hyper igm, wiskott- aldrich syndrom, and severed combined immunodeficiencies. gamunex is also indicated in idiopathic thrombocytopenia purpura (itp) to raise platelet counts to prevent bleeding or to allow a patient with itp to undergo surgery.treatment of chronic inflammatory demyelinating polyneuropathy (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.