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The electronic Medicines Compendium (eMC) contains information about UK licensed medicines.
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Winthrop Pharmaceuticals UK Ltd
One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 554 831
E-mail: UK-medicalinformation@sanofi-aventis.com
Medical Information Direct Line: +44 (0)1483 554 101
Medical Information Fax: +44 (0)1483 554 831

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: 29/01/2010
SPC Gentamicin Intrathecal 5mg/ml Solution for Injection

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 29/01/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The MAH has changed from Aventis (Roussel) to Winthrop Pharmaceuticals
Updated on 09/09/2009 and displayed until 29/01/2010
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:   03-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to dates in Section 9 and 10 due to renewal of licence
Updated on 30/08/2005 and displayed until 09/09/2009
Reasons for adding or updating:
  • Change from BAN to rINN
  • Change to section 10 (date of (partial) revision of the text
Updated on 03/06/2004 and displayed until 30/08/2005
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  gentamicin sulphate