Cubicin

RSS

daptomycin

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

Overview

This is a summary of the European public assessment report (EPAR) for Cubicin. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Cubicin.

For practical information about using Cubicin, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 20/08/2018

Authorisation details

Product details
Name
Cubicin
Agency product number
EMEA/H/C/000637
Active substance
daptomycin
International non-proprietary name (INN) or common name
daptomycin
Therapeutic area (MeSH)
  • Gram-Positive Bacterial Infections
  • Bacteremia
  • Soft Tissue Infections
  • Endocarditis, Bacterial
Anatomical therapeutic chemical (ATC) code
J01XX09
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
30
Date of issue of marketing authorisation valid throughout the European Union
18/01/2006
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

07/08/2018 Cubicin - EMEA/H/C/000637 - T/0069

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Cubicin is indicated for the treatment of the following infections.

  • Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
  • Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.

It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.

  • Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.

Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment history

Changes since initial authorisation of medicine

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