Recarbrio

RSS

imipenem / cilastatin / relebactam

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

Overview

Recarbrio is an antibiotic for treating adults with infections caused by bacteria classed as aerobic Gram-negative bacteria. It is for use when other treatments might not work.

Recarbrio contains the active substances imipenem, cilastatin and relebactam

This EPAR was last updated on 26/02/2020

Authorisation details

Product details
Name
Recarbrio
Agency product number
EMEA/H/C/004808
Active substance
  • imipenem monohydrate
  • cilastatin sodium
  • relebactam monohydrate
International non-proprietary name (INN) or common name
imipenem / cilastatin / relebactam
Therapeutic area (MeSH)
Gram-Negative Bacterial Infections
Anatomical therapeutic chemical (ATC) code
J01DH56
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
Merck Sharp & Dohme B.V. 
Date of issue of marketing authorisation valid throughout the European Union
13/02/2020
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

13/02/2020 Recarbrio - EMEA/H/C/004808 -

Contents

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Pharmacotherapeutic group

  • Antibacterials for systemic use

  • Carbapenems

Therapeutic indication

Recarbrio 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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