FDA — authorised 27 November 2024
- Application: NDA216017
- Marketing authorisation holder: BRACCO
- Local brand name: IOMERVU
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Imeron in United States
FDA authorised Imeron on 27 November 2024
Marketing authorisations
FDA — authorised 27 November 2024
- Application: NDA216016
- Marketing authorisation holder: BRACCO
- Local brand name: IOMERVU
- Indication: SOLUTION — INTRA-ARTERIAL
- Status: approved
The FDA approved Imeron, a new molecular entity, on 27 November 2024. This approval was granted to BRACCO, the marketing authorisation holder, under the standard expedited pathway. Imeron is indicated for a specific medical condition, but the exact indication is not specified in the available information.
Imeron in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Imeron approved in United States?
Yes. FDA authorised it on 27 November 2024; FDA authorised it on 27 November 2024.
Who is the marketing authorisation holder for Imeron in United States?
BRACCO holds the US marketing authorisation.