Doribax
Withdrawn
This medicine's authorisation has been withdrawn
doripenem
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 25 July 2008, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Doribax, which had been approved for the treatment of nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections.
The marketing authorisation holder (MAH) responsible for Doribax was Janssen-Cilag International N.V.
On 31 July 2014, the European Commission issued a decision to withdraw the marketing authorisation for Doribax, following its receipt of a letter dated 6 July 2014 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reasons.
Doribax was marketed in the following European countries: Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Liechtenstein, Lithuania, Luxemburg, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden and United Kingdom.
Pursuant to this decision, the European public assessment report for Doribax is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:II/0022
21/02/2012
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).
Product details
- Name of medicine
- Doribax
- Active substance
- doripenem
- International non-proprietary name (INN) or common name
- doripenem
- Therapeutic area (MeSH)
- Pneumonia, Ventilator-Associated
- Pneumonia, Bacterial
- Urinary Tract Infections
- Bacterial Infections
- Cross Infection
- Anatomical therapeutic chemical (ATC) code
- J01DH04
Pharmacotherapeutic group
Antibacterials for systemic useTherapeutic 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.
Assessment history
News on Doribax
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