مالطا - الإنجليزية - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - human normal, immunoglobulin - solution for infusion - human normal immunoglobulin 50 mg/ml - immune sera and immunoglobulins

مالطا - الإنجليزية - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - human normal, immunoglobulin - solution for infusion - human normal immunoglobulin 50 mg/ml - immune sera and immunoglobulins

مالطا - الإنجليزية - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - solution for infusion - immune sera and immunoglobulins

مالطا - الإنجليزية - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - human normal, immunoglobulin - solution for infusion - human normal immunoglobulin 50 mg/ml - immune sera and immunoglobulins

مالطا - الإنجليزية - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - human normal, immunoglobulin - solution for infusion - human normal immunoglobulin 50 mg/ml - immune sera and immunoglobulins

إسرائيل - الإنجليزية - 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)

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

csl behring pte. ltd. - human immunoglobulin - infusion, solution - human immunoglobulin 100g/l

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

the reg consultants pte. ltd. - human immunoglobulin g - injection - human immunoglobulin g 50mg/ml

إسرائيل - الإنجليزية - 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

الاتحاد الأوروبي - الإنجليزية - 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).