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Pharmaceuticals - Community Register
Community register of medicinal products for human use |
AUTHORISED |
Product information |
Invented name: | Altargo
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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 procedures |
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 |