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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 06/06/2008
SPC Otosporin Ear Drops

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 06/06/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 9 - 21 May 2008

Section 10 - 21 May 2008
Updated on 22/06/2007 and displayed until 06/06/2008
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.4: Changed Storage conditions from "keep below 15°C" too "Do not store above 25°C and protect from light"
Section 10: Now 20 June 2007
Updated on 05/11/2004 and displayed until 22/06/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.9 - Overdose
Updated on 22/04/2003 and displayed until 05/11/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 27/03/2003 and displayed until 22/04/2003
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 21/06/2002 and displayed until 27/03/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 20/08/2001 and displayed until 21/06/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 22/05/2002 and displayed until 20/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 22/05/2002
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  hydrocortisone
  neomycin
  polymyxin b sulphate