Malta - English - Medicines Authority

csl behring gmbh emil-von-behring-strasse 76, 35041 marburg, germany - immunoglobulin tetanus, human - solution for injection - immunoglobulin tetanus, human 250 iu - immune sera and immunoglobulins

New Zealand - English - Medsafe (Medicines Safety Authority)

abbvie limited - risankizumab 150 mg/ml;   - solution for injection - 150 mg/ml - active: risankizumab 150 mg/ml   excipient: glacial acetic acid polysorbate 20 sodium acetate trihydrate trehalose dihydrate water for injection - psoriatic arthritis: skyrizi is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to or are intolerant to one or more disease modifying antirheumatic drugs (dmards). skyrizi may be used as monotherapy or in combination with a conventional synthetic disease modifying antirheumatic drug (csdmard).

New Zealand - English - Medsafe (Medicines Safety Authority)

abbvie limited - risankizumab 150 mg/ml;   - solution for injection - 150 mg/ml - active: risankizumab 150 mg/ml   excipient: glacial acetic acid polysorbate 20 sodium acetate trihydrate trehalose dihydrate water for injection - psoriatic arthritis: skyrizi is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to or are intolerant to one or more disease modifying antirheumatic drugs (dmards). skyrizi may be used as monotherapy or in combination with a conventional synthetic disease modifying antirheumatic drug (csdmard).

Israel - English - Ministry of Health

teva medical marketing ltd. - immunoglobulin normal human 50 mg/ml - powder for solution for injection - immunoglobulins, normal human, for intravascular adm. - replacement therapy in:• primary immunodeficiency syndromes (pid) such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia; - common variable immunodeficiency; - severe combined immunodeficiency; - wiskott aldrich syndrome.• myeloma or chronic lymphocytic leukaemia (cll) 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 barr? syndrome. in this case gammagard s/d (solvent/detergent) is only indicated in patients showing one of the following symptoms: - progressive paresis (the patient cannot walk more than 10 m on his own); - signs of a respiratory disorder (clinically observed or demonstrated by measuring the vital capacity at the patient’s bed); - signs of oropharyngeal paresis.• kawasaki disease.allogeneic bone marrow transplantation

Israel - English - Ministry of Health

teva medical marketing ltd. - immunoglobulin normal human 50 mg/ml - powder for solution for injection - immunoglobulins, normal human, for intravascular adm. - replacement therapy in:• primary immunodeficiency syndromes (pid) such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia; - common variable immunodeficiency; - severe combined immunodeficiency; - wiskott aldrich syndrome.• myeloma or chronic lymphocytic leukaemia (cll) 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 barr? syndrome. in this case gammagard s/d (solvent/detergent) is only indicated in patients showing one of the following symptoms: - progressive paresis (the patient cannot walk more than 10 m on his own); - signs of a respiratory disorder (clinically observed or demonstrated by measuring the vital capacity at the patient’s bed); - signs of oropharyngeal paresis.• kawasaki disease.allogeneic bone marrow transplantation

Israel - English - Ministry of Health

teva medical marketing ltd. - immunoglobulin normal human 50 mg/ml - powder for solution for injection - immunoglobulins, normal human, for intravascular adm. - replacement therapy in:• primary immunodeficiency syndromes (pid) such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia; - common variable immunodeficiency; - severe combined immunodeficiency; - wiskott aldrich syndrome.• myeloma or chronic lymphocytic leukaemia (cll) 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 barr? syndrome. in this case gammagard s/d (solvent/detergent) is only indicated in patients showing one of the following symptoms: - progressive paresis (the patient cannot walk more than 10 m on his own); - signs of a respiratory disorder (clinically observed or demonstrated by measuring the vital capacity at the patient’s bed); - signs of oropharyngeal paresis.• kawasaki disease.allogeneic bone marrow transplantation

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 60 g/l - injection, solution - excipient ingredients: maltose - tbsf human immunoglobulin for intravenous use is indicated for replacement igg therapy in: * primary immunodeficiency (pid) * symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. tbsf human immunoglobulin for intravenous use is indicated for immunomodulatory therapy in: * idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count * allogeneic bone marrow transplantation * kawasaki disease * guillain-barre syndrome (gbs).

Singapore - English - HSA (Health Sciences Authority)

blood services group, health sciences authority - immunoglobulin (normal) (human) - injection - 6 g/100 ml - immunoglobulin (normal) (human) 6 g/100 ml

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - human normal immunoglobulin (human plasma protein containing at least 96% immunoglobulin) - infusion, solution - 50 mg/ml - human normal immunoglobulin (human plasma protein containing at least 96% immunoglobulin) 50 mg/ml

Malta - English - Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - immunoglobulin antihepatitis - solution for injection - immunoglobulin antihepatitis b 100 iu/ml - immune sera and immunoglobulins