Malta - English - Medicines Authority

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

Malta - English - Medicines Authority

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

Singapore - English - HSA (Health Sciences Authority)

csl behring pte. ltd. - human immunoglobulin - injection, solution - human immunoglobulin 200g/l

Israel - English - Ministry of Health

csl behring ltd., israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 200 mg / 1 ml - immunoglobulins, normal human, for extravascular adm. - replacement therapy in adults and children in primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency and wiskott-aldrich syndrome - igg subclass deficiencies with recurrent infectionsreplacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Malta - English - Medicines Authority

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

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human plasma protein >95% immunoglobulins - solution for injection - 160 gram(s)/litre - immunoglobulins, normal human; immunoglobulins, normal human, for extravascular adm. - immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration - replacement therapy in adults and children in primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency - igg subclass deficiencies with recurrent infections

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human normal immunoglobulin - solution for injection - 165 milligram(s)/millilitre - immunoglobulins, normal human; immunoglobulins, normal human, for extravascular adm.

Israel - English - Ministry of Health

csl behring ltd., israel - immunoglobulins, normal human - solution for injection - immunoglobulins, normal human 160 mg/ml - immunoglobulins, normal human, for extravascular adm. - immunoglobulins, normal human, for extravascular adm. - substitution in - primary antibody deficiency syndromes resulting from defective antibody synthesis. - protracted transitory hypogammaglobulinaemia especially in premature infants .prophylaxis of hepatitis a- before exposure- within 2 weeks after exposure בקשה לתוספת התוויה 28/4/2019indications for subcutaneous administration (scig)replacement therapy in adults, children and adolescents (0-18 years) in: • primary immunodeficiency syndromes with impaired antibody production (see section 4.4).• hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (cll), in whom prophylactic antibiotics have failed or are contra-indicated.• hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (mm) patients • hypogammaglobulinaemia in patients pre- and post- allogeneic haematopoietic stem cell transplantation (hsct)indications for intramuscular administration (imig)hepatitis a prophylaxisin adults and children and adolescents (0-18 years)• pre-exposure prophylaxis, preferably in combination with vaccination, in unvaccinated individuals travelling in less than 2 weeks to areas of hepatitis a risk.• post-exposure prophylaxis in unvaccinated individuals within 2 weeks of hepatitis a virus (hav) exposure.consideration should also be given to other official guidance on the appropriate use in hepatitis a prophylaxis. for long term hepatitis a prophylaxis, vaccination is recommended. הערה: הבקשה הינה בהתאם לנוהל ema (25.2.15)- guideline on core smpc for human normal immunoglobulin for subcutaneous and intramuscular administration

European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - human normal immunoglobulin - immunologic deficiency syndromes - immune sera and immunoglobulins, - replacement therapy in adults, children and adolescents (0-18 years) in:primary immunodeficiency syndromes with impaired antibody production.hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (cll), in whom prophylactic antibiotics have failed or are contra‑indicated.hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (mm) patients.hypogammaglobulinaemia in patients pre‑ and post‑allogeneic hematopoietic stem cell transplantation (hsct).

Canada - English - Health Canada

cutter med & biol, division of miles canada ltd. - immunoglobulin (human) - liquid - 16.5% - immunoglobulin (human) 16.5% - serums