Fluciclovine (18f)

AXUMIN 1600 MBq/ML SOLUCION INYECTABLE

1600 MEGABECQUERELIO solución inyectableSpainAuthorisedAuthorised 27 Dec 2018

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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

AxuminEuropean Union · Blue Earth Diagnostics Ireland LtdSame brand
AxuminCroatiaSame brand
AxuminItaly · Soluzione iniettabile · Blue Earth Diagnostics Ireland LTDSame brand
Axumin 1600 MBq/ml oplossing voor injectieNetherlands · Oplossing voor injectie · Blue Earth Diagnostics Ireland LtdSame brand
Axumin 3200 MBq/ml oplossing voor injectieNetherlands · Oplossing voor injectie · Blue Earth Diagnostics Ireland LtdSame brand

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Fluciclovine (18f)

AXUMIN 1600 MBq/ML SOLUCION INYECTABLE

1600 MEGABECQUERELIO solución inyectableSpainAuthorisedAuthorised 27 Dec 2018

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

Packs

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

Documents

The official texts, at the regulator.

Sources and licences

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

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 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)
Strength: 1600 MEGABECQUERELIO
Dosage form: solución inyectable
Route: vía intravenosa
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 27 Dec 2018
Registration: 1171186001
Marketing authorisation holder: Blue Earth Diagnostics Ireland Limited
Procedure: EU centralised
Supply: Uso Hospitalario
EU number: EU/1/17/1186

AXUMIN 1600 MBq/ML SOLUCION INYECTABLE 1 vial de 10 ml	723996
AXUMIN 1600 MBq/ML SOLUCION INYECTABLE 1 vial de 15 ml	727930