Fetcroja

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cefiderocol

Authorised
This medicine is authorised for use in the European Union.

Overview

Fetcroja is an antibiotic used in adults to treat infections caused by bacteria classed as aerobic Gram-negative bacteria. It is for use when other treatments might not work.

Fetcroja contains the active substance cefiderocol.

This EPAR was last updated on 08/03/2023

Authorisation details

Product details
Name
Fetcroja
Agency product number
EMEA/H/C/004829
Active substance
cefiderocol sulfate tosilate
International non-proprietary name (INN) or common name
cefiderocol
Therapeutic area (MeSH)
Gram-Negative Bacterial Infections
Anatomical therapeutic chemical (ATC) code
J01D
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Shionogi B.V.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
23/04/2020
Contact address

Herengracht 464
1017 CA
Amsterdam
The Netherlands

Product information

07/03/2023 Fetcroja - EMEA/H/C/004829 - IAIN/0014/G

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Fetcroja is indicated for the treatment of infections   due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4 and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment history

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