Locametz

RSS

gozetotide

Authorised
This medicine is authorised for use in the European Union.

Overview

Locametz is a diagnostic medicine used in adults with prostate cancer to detect prostate cancer cells with a protein called prostate‑specific membrane antigen (PSMA) using the body scan known as positron-emission tomography (PET).

It is used:

  • to find out whether prostate cancer has spread to lymph nodes and other tissues outside the prostate before curative treatment is started;
  • to find out whether prostate cancer has returned in patients whose blood levels of prostate specific antigen (PSA) are increasing after previous curative treatment;
  • to find out whether patients have PSMA-positive progressive metastatic castration-resistant prostate cancer, which may be suitable for a specific therapy called PSMA-targeted therapy. Metastatic castration-resistant prostate cancer is cancer that has spread to other parts of the body despite treatment to lower testosterone levels, including surgical removal of the testes.

Before use, the medicine is coupled (radiolabelled) with a radioactive substance called gallium (68Ga) so that it can carry radioactivity to the site of the cancer cells and allow detection of these cells using PET.

Locametz contains the active substance gozetotide.

This EPAR was last updated on 29/06/2023

Authorisation details

Product details
Name
Locametz
Agency product number
EMEA/H/C/005488
Active substance
gozetotide
International non-proprietary name (INN) or common name
gozetotide
Therapeutic area (MeSH)
Radionuclide Imaging
Anatomical therapeutic chemical (ATC) code
V09I
Publication details
Marketing-authorisation holder
Novartis Europharm Limited 
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
09/12/2022
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
D04 A9N6 
Ireland

Product information

30/01/2023 Locametz - EMEA/H/C/005488 - N/0001

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Diagnostic radiopharmaceuticals

Therapeutic 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).

Assessment history

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