Overview

The marketing authorisation for Altargo has been withdrawn at the request of the marketing authorisation holder.

Altargo : EPAR - Summary for the public

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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 keel (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 valoda (LV) (651.97 KB - PDF)

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lietuvių kalba (LT) (619.1 KB - PDF)

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magyar (HU) (639.94 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)

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español (ES) (812.94 KB - PDF)

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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 keel (ET) (750.21 KB - PDF)

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ελληνικά (EL) (1.46 MB - PDF)

First published: 28/04/2009Last updated: 15/03/2019
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français (FR) (815.25 KB - PDF)

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hrvatski (HR) (874.78 KB - PDF)

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íslenska (IS) (794.04 KB - PDF)

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italiano (IT) (800.77 KB - PDF)

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latviešu valoda (LV) (1.23 MB - PDF)

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lietuvių kalba (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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norsk (NO) (805.77 KB - PDF)

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polski (PL) (1.2 MB - PDF)

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português (PT) (846.48 KB - PDF)

First published: 28/04/2009Last updated: 15/03/2019
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română (RO) (881.66 KB - PDF)

First published: 28/04/2009Last updated: 15/03/2019
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slovenčina (SK) (1.22 MB - PDF)

First published: 28/04/2009Last updated: 15/03/2019
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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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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)

First published: 05/06/2007Last updated: 15/03/2019
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español (ES) (468.17 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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čeština (CS) (543.17 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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dansk (DA) (463.61 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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Deutsch (DE) (463.97 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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eesti keel (ET) (464.73 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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ελληνικά (EL) (542.82 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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français (FR) (464.58 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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italiano (IT) (463.94 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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latviešu valoda (LV) (543.45 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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lietuvių kalba (LT) (528.34 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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magyar (HU) (541.04 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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Malti (MT) (541.98 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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Nederlands (NL) (464.13 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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polski (PL) (544.12 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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português (PT) (464.65 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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română (RO) (524.19 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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slovenčina (SK) (543.19 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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slovenščina (SL) (509.38 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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Suomi (FI) (463.61 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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svenska (SV) (464.71 KB - PDF)

First published: 05/06/2007Last updated: 15/03/2019
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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
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

AdoptedReference Number: EMA/594074/2014

English (EN) (681.15 KB - PDF)

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

AdoptedReference 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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More information on Altargo

Public statement on Altargo: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/76365/2019

English (EN) (65.35 KB - PDF)

First published:
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