Ireland - English - HPRA (Health Products Regulatory Authority)

biotest pharma gmbh - human plasma protein >96% immunoglobulins - solution for infusion - 50 gram(s)/litre - immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human plasma protein >95% immunoglobulins - solution for injection - 160 g/l

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

Malta - English - Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - immunoglobulin rabies, human - solution for injection - immunoglobulin rabies, human 150 iu/ml - immune sera and immunoglobulins

Ireland - English - HPRA (Health Products Regulatory Authority)

biotest pharma gmbh - human plasma protein >95% immunoglobulins immunoglobulin cytomegalovirus - solution for infusion - 50 units/ml

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - hepatitis b immunoglobulin, human 160 mg/ml ((>= 98% )as human plasma proteins (exnz)) - solution for injection - 100 iu - active: hepatitis b immunoglobulin, human 160 mg/ml ((>= 98% )as human plasma proteins (exnz)) excipient: glycine water for injection - hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (< 10 iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - hepatitis b immunoglobulin, human 160 mg/ml (( >= 98%) as human plasma proteins (ex nz)) - solution for injection - 400 iu - active: hepatitis b immunoglobulin, human 160 mg/ml (( >= 98%) as human plasma proteins (ex nz)) excipient: glycine water for injection - hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (< 10 iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

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).

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma limited - human plasma protein - solution for infusion - %v/v - blood substitutes and plasma protein fractions