Uus-Meremaa - inglise - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - hydrocortisone sodium succinate 250mg;   - powder for injection - 250 mg - active: hydrocortisone sodium succinate 250mg  

Uus-Meremaa - inglise - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - hydrocortisone sodium succinate 500mg;   - powder for injection - 500 mg - active: hydrocortisone sodium succinate 500mg  

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

telix pharmaceuticals (anz) pty ltd - glu-urea-lys(ahx)-hbed-cc, quantity: 25 microgram - injection, diluent for - excipient ingredients: sodium acetate; hydrochloric acid; water for injections - illuccix, after radiolabelling with ga-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (pet) imaging combined with computerised tomography (ct) in patients with prostate cancer: who are at risk of metastasis and who are suitable for initial definitive therapy; who have suspected recurrence based on elevated serum prostate specific antigen (psa) level.

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

telix pharmaceuticals (anz) pty ltd - glu-urea-lys(ahx)-hbed-cc, quantity: 25 microgram - injection, diluent for - excipient ingredients: hydrochloric acid; sodium acetate; water for injections - illuccix, after radiolabelling with ga-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (pet) imaging combined with computerised tomography (ct) in patients with prostate cancer: who are at risk of metastasis and who are suitable for initial definitive therapy; who have suspected recurrence based on elevated serum prostate specific antigen (psa) level.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

telix pharmaceuticals (us) inc. - gozetotide (unii: 9ag41l3aoq) (gozetotide - unii:9ag41l3aoq) - illuccix, after radiolabeling with ga 68, is indicated for positron emission tomography (pet) of prostate-specific membrane antigen (psma) positive lesions in men with prostate cancer: - with suspected metastasis who are candidates for initial definitive therapy. - with suspected recurrence based on elevated serum prostate-specific antigen (psa) level. - for selection of patients with metastatic prostate cancer, for whom lutetium lu 177 vipivotide tetraxetan psma-directed therapy is indicated. none risk summary illuccix is not indicated for use in females. there are no available data with gallium ga 68 gozetotide injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. all radiopharmaceuticals, including illuccix, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. animal reproduction studies have not been conducted with gallium ga 68 gozetotide. ri

Euroopa Liit - inglise - EMA (European Medicines Agency)

biogen netherlands b.v. - dimethyl fumarate - multiple sclerosis - immunosuppressants - tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Euroopa Liit - inglise - EMA (European Medicines Agency)

biogen netherlands b.v. - peginterferon beta-1a - multiple sclerosis - immunostimulants, - treatment of relapsing remitting multiple sclerosis in adult patients.

Euroopa Liit - inglise - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - multiple sclerosis - selective immunosuppressants - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4.4 and 5.1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Euroopa Liit - inglise - EMA (European Medicines Agency)

biogen netherlands b.v. - nusinersen sodium - muscular atrophy, spinal - other nervous system drugs - spinraza is indicated for the treatment of 5q spinal muscular atrophy.

Uus-Meremaa - inglise - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - ocriplasmin 2.5 mg/ml - concentrate for injection - 2.5 mg/ml - active: ocriplasmin 2.5 mg/ml excipient: citric acid monohydrate mannitol sodium hydroxide water for injection - jetrea is indicated in adults for the treatment of vitreomacular traction (vmt), including when associated with macular hole of diameter less than or equal to 400 microns.