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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Altargo has been withdrawn at the request of the marketing authorisation holder.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

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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