Locametz (gozetotide)
- Region
- 🇪🇺 EU
- Active substance
- gozetotide
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Radionuclide Imaging
- CHMP opinion
- Thu 13 Oct 2022
- EU approval
- Fri 09 Dec 2022
- Application
- EMEA/H/C/005488
- ATC
- V09I
- Official record
- www.ema.europa.eu
Indication
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.