Singapur - inglise - HSA (Health Sciences Authority)

abbott laboratories (singapore ) private limited - immunology - the hbsag next qualitative assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma including specimens collected post mortem (non-heart-beating) on the architect isystem. the hbsag next qualitative assay is intended to be used as an aid in the diagnosis of hepatitis b virus (hbv) infection and as a screening test to prevent transmission of hbv to recipients of blood, blood components, cells, tissue and organs.

Singapur - inglise - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - immunoassay for in vitro confirmation of the presence of hepatitis b surface antigen in human serum and plasma samples repeatedly reactive when tested with the elecsys hbsag ii assay. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

abbott australasia pty ltd diagnostic division - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - this assay is a one-step immunoassay for the qualitative detection of hbsag in human serum and plasma including specimens collected post mortem (non-heart-beating) using chemiluminescent microparticle immunoassay (cmia) technology. the hbsag next qualitative assay is a chemiluminescent microparticle immunoassay (cmia) used for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma, including specimens collected post-mortem (non-heart-beating) that have been collected up to 24 hours after death, on the alinity i system.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - 60812 - hepatitis b virus surface antigen neutralization ivd, kit, chemiluminescent immunoassay - the elecsys hbsag ii auto confirm assay is a fully automated confirmatory assay, based on the principle of specific antibody neutralization, intended to be used for samples repeatedly reactive in the elecsys hbsag ii assay. polyclonal hbsag specific antibodies bind to the immunodominant epitopes of hbsag and thereby block the binding sites for the antibodies used in the elecsys hbsag ii assay. immunoassay and control for in vitro confirmation of the presence of hepatitis b surface antigen in human serum and plasma samples repeatedly reactive when tested with the elecsys hbsag ii assay. these electrochemiluminescence immunoassays (eclia) are intended for use on cobas e immunoassay analysers.

Kenya - inglise - Pharmacy and Poisons Board

glaxosmithkline pharmaceutical kenya limited likoni rd industrial area p.o box 78392 - hepatitis b vaccine (purified hbsag) - suspension for injection - 10 g hbsag. - viral vaccines: hepatitisvaccines

Singapur - inglise - HSA (Health Sciences Authority)

alcotech pte ltd - clinical toxicology - the hbsag rapid test cassette is a rapid chromatographic immunoassay for the qualitative detection of hepatitis b surface antigen in human whole blood, serum or plasma to aid in the diagnosis of hbsag infection. the product is intended to be used by trained laboratory personnel. for laboratory use only. the test provides preliminary test results. negative results will not preclude hepatitis b virus infection and they can’t be used as the sole basis for treatment or other management decision. not for self-testing use. not for near-patient use. not for blood donor screening.

Tansaania - inglise - Tanzania Medicinces & Medical Devices Authority

moraf pharmaceuticals limited, tanzania - hbsag rapid test strip -

Tansaania - inglise - Tanzania Medicinces & Medical Devices Authority

moraf pharmaceuticals limited, tanzania - hbsag rapid test strip -

Euroopa Liit - inglise - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - antineoplastic agents - rituzena is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)rituzena is indicated for the treatment of previously untreated patients with stage iii iv follicular lymphoma in combination with chemotherapy.rituzena monotherapy is indicated for treatment of patients with stage iii iv follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy.rituzena is indicated for the treatment of patients with cd20 positive diffuse large b cell non hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.chronic lymphocytic leukaemia (cll)rituzena in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory cll. only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituzenaor patients refractory to previous rituzena plus chemotherapy.granulomatosis with polyangiitis and microscopic polyangiitisrituzena, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa).

Iisrael - inglise - Ministry of Health

padagis israel agencies ltd, israel - rituximab - concentrate for solution for infusion - rituximab 10 mg/ml - rituximab - truxima is indicated in adults for the following indications: * non-hodgkin’s lymphoma (nhl) truxima is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-hodgkin’s lymphoma. truxima is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy. truxima is indicated for the treatment of patients with cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop chemotherapy. truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.* chronic lymphocytic leukaemia (cll)truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory cll. only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy.* granulomatosis with polyangiitis and microscopic polyangiitistruxima, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis (gpa) (wegener’s granulomatosis (wg)) and microscopic polyangiitis (mpa).*pemphigus vulgaris (pv):truxima is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (pv).