Fluciclovine (18f)

Axumin 3200 MBq/ml oplossing voor injectie

Oplossing voor injectieNetherlandsAuthorisedAuthorised 22 May 2017

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

AxuminEuropean UnionAuthorised

AXUMIN 1600 MBq/ML SOLUCION INYECTABLESpain · 1600 MEGABECQUERELIO · solución inyectable · Blue Earth Diagnostics Ireland LimitedSame brand
AXUMIN 3200 MBq/ML SOLUCION INYECTABLESpain · 3200 MEGABECQUERELIO · solución inyectable · Blue Earth Diagnostics Ireland LimitedSame brand
AxuminEuropean Union · Blue Earth Diagnostics Ireland LtdSame brand
AxuminCroatiaSame brand
AxuminItaly · Soluzione iniettabile · Blue Earth Diagnostics Ireland LTDSame brand

Documents

The official texts, at the regulator.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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Fluciclovine (18f)

Axumin 3200 MBq/ml oplossing voor injectie

Oplossing voor injectieNetherlandsAuthorisedAuthorised 22 May 2017

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

AxuminEuropean UnionAuthorised

Documents

The official texts, at the regulator.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

College ter Beoordeling van Geneesmiddelen

College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.

Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim · Added 8 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Fluciclovine (18f)
Dosage form: Oplossing voor injectie
Route: Intraveneus gebruik
Register: Netherlands (CBG-MEB)
Status: Authorised
Status in the register: Ingeschreven
Authorised: 22 May 2017
Registration: EU/1/17/1186
Marketing authorisation holder: Blue Earth Diagnostics Ireland Ltd
ATC code: V09IX12
Group: Various
Procedure: EU centralised
Supply: Uitsluitend recept
EMA product number: EMEA/H/C/004197
EU number: EU/1/17/1186