Malta - English - Medicines Authority

octapharma (ip) limited - immunoglobulin g, human - solution for injection - immunoglobulin g, human 165 mg/ml - immune sera and immunoglobulins

European Union - English - EMA (European Medicines Agency)

cangene europe limited - human hepatitis b immunoglobulin - immunization, passive; hepatitis b - specific immunoglobulins - immunoprophylaxis of hepatitis b - in case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown).- in haemodialysed patients, until vaccination has become effective.- in the newborn of a hepatitis b virus carrier-mother.- in subjects who did not show an immune response (no measurable hepatitis b antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis b.consideration should also be given to other official guidance on the appropriate use of human hepatitis b immunoglobulin for intramuscular use.

Malta - English - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - immunoglobulin g, human - solution for injection - immunoglobulin g, human 165 mg/ml - immune sera and immunoglobulins

Israel - English - Ministry of Health

kamada ltd, israel - human hepatitis b immunoglobulin - solution for injection - human hepatitis b immunoglobulin 500 iu - hepatitis b immunoglobulin - hepatitis b immunoglobulin - prevention of hepatitis b virus (hbv) re-infection in hbsag and hbv-dna negative adult patients at least one week after liver transplantation for hepatitis b induced liver failure.hbv-dna negative status should be confirmed within the last 3 months prior to olt. patients should be hbsag negative before treatment start.the concomitant use of adequate virostatic agents should be considered as standard of hepatitis b re-infection prophylaxis.

Israel - English - Ministry of Health

kamada ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 100 mg/ml - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, and children and adolescents (0-18 years) in: - primary immunodeficiency syndromes (pid) with impaired antibody production - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of <4 g/l * psaf= failure to mount at least a 2-fold rise in igg antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccinesimmunomodulation 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 (in conjunction with acetylsalicylic acid) - chronic inflammatory demyelinating polyradiculoneuropathy (cidp) - multifocal motor neuropathy (mmn)

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 3.2 g - injection, solution - excipient ingredients: human immunoglobulin a; glycine; water for injections - evogam is indicated in adults and children for replacement therapy in: primary immunodeficiency disease (pid) and symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 1.6 g - injection, solution - excipient ingredients: water for injections; human immunoglobulin a; glycine - evogam is indicated in adults and children for replacement therapy in: primary immunodeficiency disease (pid) and symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 0.8 g - injection, solution - excipient ingredients: glycine; human immunoglobulin a; water for injections - evogam is indicated in adults and children for replacement therapy in: primary immunodeficiency disease (pid) and symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

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

bio products laboratory ltd - varicella-zoster immunoglobulin human - solution for injection - 250mg

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

bio products laboratory ltd - hepatitis b immunoglobulin human - solution for injection - 100unit/1ml