EMA — authorised 9 December 2022
- Marketing authorisation holder: NOVARTIS EUROPHARM LIMITED
- Status: approved
🇪🇺 Locametz in European Union
EMA authorised Locametz on 9 December 2022
Marketing authorisations
EMA — authorised 9 December 2022
- Application: EMEA/H/C/005488
- Marketing authorisation holder: Novartis Europharm Limited
- Local brand name: Locametz
- 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
- Status: approved
Locametz in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Locametz approved in European Union?
Yes. EMA authorised it on 9 December 2022; EMA authorised it on 9 December 2022.
Who is the marketing authorisation holder for Locametz in European Union?
NOVARTIS EUROPHARM LIMITED holds the EU marketing authorisation.