Altargo
Withdrawn
This medicine's authorisation has been withdrawn
retapamulin
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 25 February 2019 the European Commission withdrew the marketing authorisation for Altargo (retapamulin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Glaxo Group Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Altargo was granted marketing authorisation in the EU on 24 May 2007 for the short treatment of some superficial skin infections in adults and children from the age of 9 months. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2012.
The European Public Assessment Report (EPAR) for Altargo is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:N/0030
09/11/2015
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).
Product details
- Name of medicine
- Altargo
- 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
Pharmacotherapeutic group
Antibiotics and chemotherapeutics for dermatological useTherapeutic 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.
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