Altargo

retapamulin

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Altargo?

Altargo is an ointment that contains the active substance retapamulin.

What is Altargo used for?

Altargo is an antibiotic medicine. It is used for short-term treatment of superficial skin infections. It can be used to treat impetigo (a skin infection causing crusting scabs), and small infected lacerations (cuts), abrasions (grazes) and wounds that have been sutured (stitched). Altargo should not be used to treat infections known or thought likely to be due to methicillin-resistant Staphylococcus aureus (MRSA), as it may not work against this type of infection. However, it may be used to treat infections caused by other types of Staphylococcus aureus. Prescribers should consider official guidance on the use of antibacterial agents.

The medicine can only be obtained with a prescription.

How is Altargo used?

Altargo should only be used on the skin. It is applied onto the affected area as a thin layer twice a day for five days. The treated area can be covered with a sterile bandage or gauze dressing. Altargo can be used in patients from the age of nine months, but in patients under 18 years of age, the area to be treated should not be more than 2% of the body’s surface. If there is no response to treatment after two to three days, doctors should re-evaluate the patient and consider alternative treatments.

How does Altargo work?

The active substance in Altargo, retapamulin, is an antibiotic belonging to the ‘pleuromutilin’ class. It is derived from a compound produced by certain types of fungus. It works by blocking the bacteria’s ribosomes (the parts of the cells where proteins are produced), inhibiting the growth of the bacteria. The full list of bacteria against which Altargo is active can be found in the summary of product characteristics.

How has Altargo been studied?

The effects of Altargo were first tested in experimental models before being studied in humans. Altargo has been studied in five main studies involving over 3,000 patients aged from 9 months upwards. Two studies were carried out in patients with impetigo. The first compared the effects of five days’ treatment with Altargo to those of placebo (a dummy treatment) in 213 patients, and the second compared Altargo to fusidic acid (another antibiotic ointment) in 519 patients. The other three studies compared the effects of five days’ treatment with Altargo to those of cefalexin (an oral antibiotic medicine): two studies were carried out in a total of 1,918 patients with infected skin wounds, and the final study was carried out in 545 patients with infected dermatitis (skin inflammation). In all five studies, the main measure of effectiveness was the proportion of patients whose infections had cleared up after the end of treatment.

What benefit has Altargo shown during the studies?

In patients with impetigo, Altargo was more effective than placebo, with 119 (85.6%) of the 139 patients using Altargo and 37 (52.1%) of the 71 using placebo responding to treatment. Altargo was at least as effective as fusidic acid, with 314 (99.1%) of 317 and 141 (94.0%) of 150 patients, respectively, responding to treatment. For the treatment of infected skin wounds, Altargo and cefalexin had similar response rates: when the results of both skin wound studies were taken together, around 90% of both groups of patients responded to treatment. However, these two studies found that Altargo was not sufficiently effective in the treatment of abscesses (cavities containing pus) or of infections known or likely to be caused by MRSA.

The data presented were insufficient to support the use of Altargo in the treatment of infected dermatitis.

What is the risk associated with Altargo?

The most common side effect with Altargo (seen in between 1 and 10 patients in 100) is irritation at the site of application. For the full list of all side effects reported with Altargo, see the package leaflet.

Altargo should not be used in people who may be hypersensitive (allergic) to retapamulin or any of the other ingredients.

Why has Altargo been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Altargo’s benefits are greater than its risks for the short term treatment of the following superficial skin infections:

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

The Committee recommended that Altargo be given marketing authorisation.

Other information about Altargo

The European Commission granted a marketing authorisation valid throughout the European Union for Altargo to Glaxo Group Ltd on 24 May 2007.

Name Language First published Last updated
Altargo : EPAR - Summary for the public BG = bălgarski 2007-11-06  
Altargo : EPAR - Summary for the public ES = español 2007-11-06  
Altargo : EPAR - Summary for the public CS = čeština 2007-11-06  
Altargo : EPAR - Summary for the public DA = dansk 2007-11-06  
Altargo : EPAR - Summary for the public DE = Deutsch 2007-11-06  
Altargo : EPAR - Summary for the public ET = eesti keel 2007-11-06  
Altargo : EPAR - Summary for the public EL = elliniká 2007-11-06  
Altargo : EPAR - Summary for the public EN = English 2007-11-06  
Altargo : EPAR - Summary for the public FR = français 2007-11-06  
Altargo : EPAR - Summary for the public IT = italiano 2007-11-06  
Altargo : EPAR - Summary for the public LV = latviešu valoda 2007-11-06  
Altargo : EPAR - Summary for the public LT = lietuvių kalba 2007-11-06  
Altargo : EPAR - Summary for the public HU = magyar 2007-11-06  
Altargo : EPAR - Summary for the public MT = Malti 2007-11-06  
Altargo : EPAR - Summary for the public NL = Nederlands 2007-11-06  
Altargo : EPAR - Summary for the public PL = polski 2007-11-06  
Altargo : EPAR - Summary for the public PT = português 2007-11-06  
Altargo : EPAR - Summary for the public RO = română 2007-11-06  
Altargo : EPAR - Summary for the public SK = slovenčina 2007-11-06  
Altargo : EPAR - Summary for the public SL = slovenščina 2007-11-06  
Altargo : EPAR - Summary for the public FI = suomi 2007-11-06  
Altargo : EPAR - Summary for the public SV = svenska 2007-11-06  

This EPAR was last updated on 03/12/2015 .

Authorisation details

Product details

Product details for Altargo
NameAltargo
Agency product numberEMEA/H/C/000757
Active substance

retapamulin

International non-proprietary name (INN) or common name

retapamulin

Therapeutic area ImpetigoStaphylococcal Skin Infections
Anatomical therapeutic chemical (ATC) code D06AX13

Publication details

Publication details for Altargo
Marketing-authorisation holder

Glaxo Group Ltd

Revision15
Date of issue of marketing authorisation valid throughout the European Union24/05/2007

Contact address:

Glaxo Group Ltd
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

Product information

Product information

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

Name Language First published Last updated
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03
Altargo : EPAR - Product Information SV = svenska 2009-04-28 2015-12-03

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.


Name Language First published Last updated
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  
Altargo : EPAR - All Authorised presentations SV = svenska 2007-06-05  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Altargo : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-04-28 2015-12-03
Altargo-H-C-757-P46-017.1 : EPAR - Assessment Report SV = svenska 2014-12-08  
Altargo-H-C-757-P46-0017 : EPAR - Assessment Report SV = svenska 2014-12-08  

Initial marketing-authorisation documents

Name Language First published Last updated
Altargo : EPAR - Scientific Discussion SV = svenska 2007-06-19  
Altargo : EPAR - Procedural steps taken before authorisation SV = svenska 2007-06-05  

Authorised

This medicine is approved for use in the European Union