Doribax
doripenem
Table of contents
Overview
The marketing authorisation for Doribax has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Doribax
|
| Agency product number |
EMEA/H/C/000891
|
| Active substance |
doripenem
|
| International non-proprietary name (INN) or common name |
doripenem
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
J01DH04
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Janssen-Cilag International NV
|
| Revision |
10
|
| Date of issue of marketing authorisation valid throughout the European Union |
25/07/2008
|
| Contact address |
Turnhoutseweg, 30 |
Product information
21/02/2012 Doribax - EMEA/H/C/000891 - II/0022
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
Doribax is indicated for the treatment of the following infections in adults:
- nosocomial pneumonia (including ventilator-associated pneumonia);
- complicated intra-abdominal infections;
- complicated urinary tract infections.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.