Zinforo

RSS

ceftaroline fosamil

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

Overview

This is a summary of the European public assessment report (EPAR) for Zinforo. 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 Zinforo.

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

This EPAR was last updated on 06/12/2018

Authorisation details

Product details
Name
Zinforo
Agency product number
EMEA/H/C/002252
Active substance
Ceftaroline fosamil
International non-proprietary name (INN) or common name
ceftaroline fosamil
Therapeutic area (MeSH)
  • Community-Acquired Infections
  • Skin Diseases, Infectious
  • Pneumonia
Anatomical therapeutic chemical (ATC) code
J01DI02
Publication details
Marketing-authorisation holder
Pfizer Ireland Pharmaceuticals
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
22/08/2012
Contact address
Operations Services Group
Ringaskiddy
County Cork
Ireland

Product information

22/11/2018 Zinforo - EMEA/H/C/002252 - N/0040

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

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

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Zinforo is indicated for the treatment of the following infections in adults and children from the age of 2 months:

  • Complicated skin and soft tissue infections (cSSTI);
  • Community-acquired pneumonia (CAP).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating