United States - English - NLM (National Library of Medicine)

ucla biomedical cyclotron - gallium ga-68 gozetotide (unii: zj0ekr6m10) (gallium ga-68 gozetotide - unii:zj0ekr6m10) - gallium ga 68 gozetotide injection 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. none risk summary gallium ga 68 gozetotide injection 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 gallium ga 68 gozetotide injection, 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. risk summary gallium ga 68 gozetotide injection is not indicated for use in females. there are no data

United States - English - 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

United States - English - NLM (National Library of Medicine)

ucsf radiopharmaceutical facility - gallium ga-68 gozetotide (unii: zj0ekr6m10) (gallium ga-68 gozetotide - unii:zj0ekr6m10) - gallium ga 68 gozeotide injection 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. none risk summary gallium ga 68 gozetotide injection 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 gallium ga 68 gozetotide injection, 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 injection. risk summary gallium ga 68 gozetotide injection is not indicated for use in females. there ar

United States - English - NLM (National Library of Medicine)

advanced accelerator applications usa, inc - gozetotide (unii: 9ag41l3aoq) (gozetotide - unii:9ag41l3aoq) - locametz, after radiolabeling with gallium-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 locametz is not indicated for use in females. there are no available data with gallium ga 68 gozetotide 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 locametz, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. animal reproduction studies have not been conducted with gallium ga 68 gozetotide. risk summar

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - gozetotide - injection, powder, lyophilized, for solution - gozetotide 25μg/vial

European Union - English - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - radionuclide imaging - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.4).

Canada - English - Health Canada

novartis pharmaceuticals canada inc - gallium (68ga) gozetotide - kit - 25mcg - gallium (68ga) gozetotide 25mcg

Canada - English - Health Canada

telix pharmaceuticals (us), inc. - gallium (68ga) gozetotide - powder for solution - 25mcg - gallium (68ga) gozetotide 25mcg

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

advanced accelerator applications (uk & ireland) ltd - gozetotide - kit for radiopharmaceutical preparation - 25microgram

Israel - English - Ministry of Health

novartis israel ltd - lutetium (177lu) vipivotide tetraxetan - solution for injection / infusion - lutetium (177lu) vipivotide tetraxetan 1000 mbq/ml - lutetium (177lu) vipivotide tetraxetan - pluvicto is indicated for the treatment of adult patients with prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with androgen receptor (ar) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.