Fetcroja
cefiderocol
Table of contents
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.
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List item
Fetcroja : EPAR - Medicine overview (PDF/106.82 KB)
First published: 29/04/2020
Last updated: 04/05/2020
EMA/115665/2020 -
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Fetcroja : EPAR - Risk-management-plan summary (PDF/336.06 KB)
First published: 29/04/2020
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 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 | |
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Marketing-authorisation holder |
Shionogi B.V.
|
Revision |
7
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Date of issue of marketing authorisation valid throughout the European Union |
23/04/2020
|
Contact address |
Herengracht 464 |
Product information
21/11/2023 Fetcroja - EMEA/H/C/004829 - P46/05
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.