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

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

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

xiel ltd - mertiatide - kit for radiopharmaceutical preparation - 200microgram

European Union - English - EMA (European Medicines Agency)

ge healthcare b.v. - ioflupane (123l) - tomography, emission-computed, single-photon; lewy body disease; parkinson disease; alzheimer disease - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only.datscan is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:in adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic parkinson’s disease, multiple system atrophy and progressive supranuclear palsy. datscan is unable to discriminate between parkinson's disease, multiple system atrophy and progressive supranuclear palsy.in adult patients, to help differentiate probable dementia with lewy bodies from alzheimer’s disease. datscan is unable to discriminate between dementia with lewy bodies and parkinson’s disease dementia.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited  - lutetium (177lu) vipivotide tetraxetan - prostatic neoplasms, castration-resistant - therapeutic radiopharmaceuticals - pluvicto in combination with androgen deprivation therapy (adt) with or without androgen receptor (ar) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with ar pathway inhibition and taxane based chemotherapy.

European Union - English - EMA (European Medicines Agency)

bayer ag - radium (223ra) dichloride - prostatic neoplasms - therapeutic radiopharmaceuticals - xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.

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

royal adelaide hospital radiopharmacy - antimony trisulfide, quantity: 1.1 mg/ml - injection, solution - excipient ingredients: water for injections; monobasic sodium phosphate dihydrate; dibasic sodium phosphate - technetium [99mtc] colloidal antimony sulphide injection is used for visualisation of lymphatic drainage following intradermal administration in the following conditions: lymphoedema, primary melanoma and breast carcinoma.

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

wisconsin medical radiopharmacy, llc - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f 18 injection is indicated for positron emission tomography (pet) imaging in the following settings: for assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. none risk summary data from published case series and case reports describe fludeoxyglucose f 18 injection crossing the placenta with uptake by the fetus (see data ). all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose

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

jubilant drax image radiopharmacies, inc. dba jubilant radiopharma - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 200 mci in 1 ml - sodium fluoride f 18 injection usp is indicated for diagnostic positron emission tomography (pet) imaging of bone to define areas of altered osteogenic activity. none. pregnancy category c any radiopharmaceutical including sodium fluoride f 18 injection has a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. animal reproductive and developmental toxicity studies have not been conducted with sodium fluoride f 18 injection. prior to the administration of sodium fluoride f 18 injection to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f 18 injection should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f 18 injection is excreted into human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of sodiu

European Union - English - EMA (European Medicines Agency)

itm medical isotopes gmbh - lutetium (177lu) chloride - radionuclide imaging - therapeutic radiopharmaceuticals - endolucinbeta is a radiopharmaceutical precursor, and it is not intended for direct use in patients. it is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177lu) chloride.

European Union - English - EMA (European Medicines Agency)

advanced accelerator applications - lutetium (177lu) oxodotreotide - neuroendocrine tumors - other therapeutic radiopharmaceuticals - lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (g1 and g2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (gep‑nets) in adults.