Eptacog beta activado

Cevenfacta 5 MG (225 Kiu) Polvo y Disolvente Para Solucion Inyectable

5 mg polvo y disolvente para solución inyectableSpainMarketedAuthorised 9 Jan 2023

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.

CevenfactaEuropean UnionAuthorised

Packs

Pack	Code	Status
CEVENFACTA 5 MG (225 KIU) POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE, 1 vial de polvo y 1 jeringa precargada de disolvente	759311

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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Eptacog beta activado

Cevenfacta 5 MG (225 Kiu) Polvo y Disolvente Para Solucion Inyectable

5 mg polvo y disolvente para solución inyectableSpainMarketedAuthorised 9 Jan 2023

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.

CevenfactaEuropean UnionAuthorised

Packs

Pack	Code	Status
CEVENFACTA 5 MG (225 KIU) POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE, 1 vial de polvo y 1 jeringa precargada de disolvente	759311

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

Register entryAEMPS

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: Eptacog beta activado
Strength: 5 mg
Dosage form: polvo y disolvente para solución inyectable
Route: vía intravenosa
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 9 Jan 2023
Registration: 1221664003
Marketing authorisation holder: Laboratoire Francais Du Fractionnement Et Des Biotechnologies
Procedure: EU centralised
Supply: Uso Hospitalario
EU number: EU/1/22/1664

Eptacog beta activado · 2 mg · polvo y disolvente para solución inyectable

Spain