Altargo

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retapamulin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Altargo has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 15/03/2019

Authorisation details

Product details
Name
Altargo
Agency product number
EMEA/H/C/000757
Active substance
retapamulin
International non-proprietary name (INN) or common name
retapamulin
Therapeutic area (MeSH)
  • Impetigo
  • Staphylococcal Skin Infections
Anatomical therapeutic chemical (ATC) code
D06AX13
Publication details
Marketing-authorisation holder
Glaxo Group Ltd
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
24/05/2007
Contact address
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

Product information

09/11/2015 Altargo - EMEA/H/C/000757 - N/0030

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

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

Therapeutic indication

Short term treatment of the following superficial skin infections:

  • impetigo;
  • infected small lacerations, abrasions or sutured wounds.

See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus.

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

Assessment history

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