Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Altargo   
Auth. number : EU/1/07/390
Active substance : retapamulin
ATC: Anatomical main group: D - Dermatologicals
Therapeutic subgroup: D06 - Antibiotics and chemotherapeutics for dermatological use
Pharmacological subgroup: D06A - Antibiotics for topical use
Chemical subgroup: D06AX - Other antibiotics for topical use
Chemical substance: D06AX13 - retapamulin
(See WHO ATC Index)
Indication: Short term treatment of the following superficial skin infections in adults, adolescents, infants and
children (aged from nine months) (see section 5.1):
• 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 medicinal products.
Marketing Authorisation Holder: Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
29/05/2007 Centralised - Authorisation EMEA/H/C/757 (2007)2301 of 24/05/2007
08/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/757/IB/1
16/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/757/IB/3
09/01/2008 Centralised - Notification EMEA/H/C/757/N/2
Updated with Decision(2009)2700 of 02/04/2009
08/04/2008 Centralised - Notification EMEA/H/C/757/N/4
Updated with Decision(2009)2700 of 02/04/2009
17/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/757/IA/6
17/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/757/IA/6
06/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/757/IB/7
06/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/757/IB/9
06/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/757/IB/5
17/02/2009 Centralised - Variation EMEA/H/C/757/IA/11
Updated with Decision(2009)2700 of 02/04/2009
04/04/2009 Centralised - Variation EMEA/H/C/757/II/10 (2009)2700 of 02/04/2009
09/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/757/IA/14
10/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/757/IB/17
24/12/2009 Centralised - Variation EMEA/H/C/757/II/13 (2009)10702 of 21/12/2009
28/01/2010 Centralised - Variation EMEA/H/C/757/II/15 (2010)526 of 25/01/2010
17/03/2010 Centralised - Variation EMEA/H/C/757/II/12 (2010)1761 of 15/03/2010
29/04/2010 Centralised - Variation EMEA/H/C/757/II/16 (2010)2836 of 27/04/2010
08/09/2010 Centralised - Variation EMEA/H/C/757/II/18 (2010)6134 of 01/09/2010
19/01/2011 Centralised - Variation EMEA/H/C/757/IG/34/G
Updated with Decision(2011)1488 of 28/02/2011
04/03/2011 Centralised - Variation EMEA/H/C/757/II/19 (2011)1488 of 28/02/2011
27/04/2011 Centralised - Variation EMEA/H/C/757/II/20 (2011)2953 of 20/04/2011
26/04/2012 Centralised - Renewal EMEA/H/C/757/R/23 (2012)2868 of 20/04/2012
18/04/2013 Centralised - Variation EMEA/H/C/757/IG/279
Updated with Decision(2014)2156 of 27/03/2014
31/03/2014 Centralised - Yearly update (2014)2156 of 27/03/2014
02/06/2015 Centralised - Variation EMEA/H/C/757/IB/29
Updated with Decision(2016)3533 of 02/06/2016
09/11/2015 Centralised - Notification EMEA/H/C/757/N/30
Updated with Decision(2016)3533 of 02/06/2016
06/06/2016 Centralised - Yearly update (2016)3533 of 02/06/2016