Altargo

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Withdrawn

This medicine's authorisation has been withdrawn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Assessment Report (EPAR) for Altargo is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Altargo : EPAR - Summary for the public

English (EN) (472.97 KB - PDF)

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български (BG) (1.12 MB - PDF)

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español (ES) (505.45 KB - PDF)

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čeština (CS) (650.52 KB - PDF)

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dansk (DA) (504.78 KB - PDF)

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Deutsch (DE) (506.21 KB - PDF)

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eesti (ET) (504.17 KB - PDF)

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ελληνικά (EL) (676.26 KB - PDF)

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français (FR) (506.58 KB - PDF)

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italiano (IT) (505.1 KB - PDF)

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latviešu (LV) (651.97 KB - PDF)

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lietuvių (LT) (619.1 KB - PDF)

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magyar (HU) (639.94 KB - PDF)

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Malti (MT) (650.13 KB - PDF)

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Nederlands (NL) (505.72 KB - PDF)

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polski (PL) (654.82 KB - PDF)

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português (PT) (505.57 KB - PDF)

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română (RO) (614.22 KB - PDF)

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slovenčina (SK) (644.28 KB - PDF)

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slovenščina (SL) (635.63 KB - PDF)

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suomi (FI) (504.95 KB - PDF)

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svenska (SV) (504.61 KB - PDF)

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Product information

Altargo : EPAR - Product Information

English (EN) (799.43 KB - PDF)

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български (BG) (1.42 MB - PDF)

Prima publicare: 28/04/2009 Cea mai recent: 15/03/2019
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español (ES) (812.94 KB - PDF)

Prima publicare: 28/04/2009 Cea mai recent: 15/03/2019
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čeština (CS) (1.28 MB - PDF)

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dansk (DA) (815.41 KB - PDF)

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Deutsch (DE) (809.14 KB - PDF)

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eesti (ET) (750.21 KB - PDF)

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ελληνικά (EL) (1.46 MB - PDF)

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français (FR) (815.25 KB - PDF)

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hrvatski (HR) (874.78 KB - PDF)

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italiano (IT) (800.77 KB - PDF)

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latviešu (LV) (1.23 MB - PDF)

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lietuvių (LT) (851.86 KB - PDF)

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magyar (HU) (1.23 MB - PDF)

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Malti (MT) (1.24 MB - PDF)

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Nederlands (NL) (813.69 KB - PDF)

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polski (PL) (1.2 MB - PDF)

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português (PT) (846.48 KB - PDF)

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română (RO) (881.66 KB - PDF)

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slovenčina (SK) (1.22 MB - PDF)

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slovenščina (SL) (1.18 MB - PDF)

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suomi (FI) (806.83 KB - PDF)

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svenska (SV) (780.46 KB - PDF)

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Íslenska (IS) (794.04 KB - PDF)

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norsk (NO) (805.77 KB - PDF)

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Latest procedure affecting product information:N/0030
09/11/2015
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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).

Altargo : EPAR - All Authorised presentations

English (EN) (464.31 KB - PDF)

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български (BG) (550.48 KB - PDF)

Prima publicare: 05/06/2007 Cea mai recent: 15/03/2019
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español (ES) (468.17 KB - PDF)

Prima publicare: 05/06/2007 Cea mai recent: 15/03/2019
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čeština (CS) (543.17 KB - PDF)

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dansk (DA) (463.61 KB - PDF)

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Deutsch (DE) (463.97 KB - PDF)

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eesti (ET) (464.73 KB - PDF)

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ελληνικά (EL) (542.82 KB - PDF)

Prima publicare: 05/06/2007 Cea mai recent: 15/03/2019
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français (FR) (464.58 KB - PDF)

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italiano (IT) (463.94 KB - PDF)

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latviešu (LV) (543.45 KB - PDF)

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lietuvių (LT) (528.34 KB - PDF)

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magyar (HU) (541.04 KB - PDF)

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Malti (MT) (541.98 KB - PDF)

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Nederlands (NL) (464.13 KB - PDF)

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polski (PL) (544.12 KB - PDF)

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português (PT) (464.65 KB - PDF)

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română (RO) (524.19 KB - PDF)

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slovenčina (SK) (543.19 KB - PDF)

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slovenščina (SL) (509.38 KB - PDF)

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suomi (FI) (463.61 KB - PDF)

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svenska (SV) (464.71 KB - PDF)

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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 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.

Authorisation details

EMA product number
EMEA/H/C/000757
Marketing authorisation holder
Glaxo Group Ltd

980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

Marketing authorisation issued
24/05/2007
Withdrawal of marketing authorisation
25/02/2019
Revision
15

Assessment history

Altargo : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (627.01 KB - PDF)

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Altargo-H-C-757-P46-017.1 : EPAR - Assessment Report

Adopted Reference Number: EMA/594074/2014

English (EN) (681.15 KB - PDF)

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Altargo-H-C-757-P46-0017 : EPAR - Assessment Report

Adopted Reference Number: EMA/594074/2014

English (EN) (684.34 KB - PDF)

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Altargo : EPAR - Scientific Discussion

English (EN) (912.15 KB - PDF)

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Altargo : EPAR - Procedural steps taken before authorisation

English (EN) (469.22 KB - PDF)

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