New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - anti-d [rho] immunoglobulin 625 [iu] - solution for injection - 625 iu - active: anti-d [rho] immunoglobulin 625 [iu] excipient: glycine water for injection - rh(d) immunoglobulin-vf is indicated for the prevention of rh sensitisation in rh(d) negative females at or below child bearing age.

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

Israel - English - Ministry of Health

takeda israel ltd - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 100 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - ivig can be used in all age ranges, unless otherwise specified below.replacement therapy 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.children and adolescents (age 0-18) with congenital aids and recurrent bacterial infections.hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (hsct).immunomodulationprimary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count.guillain barré syndrome.kawasaki disease.

Israel - English - Ministry of Health

kamada ltd, israel - anti-d immunoglobulins - solution for injection - anti-d immunoglobulins 150 mcg/ml - anti-d (rh) immunoglobulin - anti-d (rh) immunoglobulin - pregnancy/other obstetric conditions, suppression of rh immunization in non-sensitized rh0 (d) negative women delivering an rh0 positive baby or when the baby's rh type is unknown. suppression of rh immunization after spontaneous or induced abortions threatened abortion associated with maternal bleeding amniocentesis chorionic villus sampling ruptured tubal pregnancy and significant abdominal trauma. kam rh0 -d im should be given within 72 hours of the event. it may be given even after up to one month although efficacy may be somewhat reduced.transfusion: suppression of rh isoimmunization in rh0 (d) antigen-negative patients transfused with rh0 (d) antigen-positive rbcs of blood components containing rh0 (d) antigen-positive rbcs . initate treatment within 72 hours of exposure.

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - immunoglobulin (polyvalent) (human) - injection - 160 mg/ml - immunoglobulin (polyvalent) (human) 160 mg/ml

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

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

csl behring uk ltd - anti-d (rho) immunoglobulin - solution for injection - 750unit/1ml

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

roche products pty ltd - satralizumab, quantity: 120 mg - injection, solution - excipient ingredients: aspartic acid; histidine; arginine; poloxamer; water for injections - enspryng is indicated as monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of adults with neuromyelitis optica spectrum disorders (nmosd) who have an anti-aquaporin 4 antibody (aqp4)-igg (also termed nmo-igg) positive status.

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

novartis pharmaceuticals australia pty ltd - ofatumumab, quantity: 50 mg/ml - injection, solution - excipient ingredients: arginine; sodium acetate trihydrate; sodium chloride; polysorbate 80; disodium edetate; hydrochloric acid; water for injections - bonspri is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) to delay the progression of physical disability and reduce the frequency of relapse (refer to section 5.1).

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

novartis pharmaceuticals australia pty ltd - ofatumumab, quantity: 50 mg/ml - injection, solution - excipient ingredients: arginine; sodium acetate trihydrate; sodium chloride; polysorbate 80; disodium edetate; hydrochloric acid; water for injections - bonspri is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) to delay the progression of physical disability and reduce the frequency of relapse (refer to section 5.1).