Recarbrio

imipenem / cilastatin / relebactam

Table of contents

Opinion

On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Recarbrio. The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.

The CHMP adopted new indications as follows:

  • Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults.
  • Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults.

For information, the full indications for Recarbrio will be as follows1:

Recarbrio is indicated for:

  • Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults (see sections 4.4 and 5.1).
  • Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults.
  • 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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold.

Key facts

Name
Recarbrio
Agency product number
EMEA/H/C/004808
International non-proprietary name (INN) or common name
  • imipenem / cilastatin / relebactam
Active substance
  • imipenem monohydrate
  • cilastatin sodium
  • relebactam monohydrate
Therapeutic area
Gram-Negative Bacterial Infections
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.

Date opinion adopted
15/10/2020
Company name
Merck Sharp & Dohme B.V. 
Status
Positive
Application type
Post-authorisation

Related content

How useful was this page?

Add your rating