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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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: 15/06/2007
SPC Testogel

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 15/06/2007 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • 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:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2: Qualitative & Quantative composition - addition of text " For a full list of excipients" has been inserted
Section 4.4: Special Warnings & precautions for use:  - determination of lipids profile has been added 
Section 4.7: Effects on ability to drive and use machines: The text has been amended to read "No studies on the effects on the ability to drive and use machines have been performed."
Section 4.8 Undersirable effects: The format has changed to tabular rather than paragraphs, also addition of some organ system classes and their common adverse reactions.  
Section 9: Date of first authorisation / Renewal of the authorisation: - This has been updated from 3 March 2003 to 4 November 2006
Section 10: Date of Revision of the text: Updated from 5 February 2004 to 4 November 2006
  
Updated on 20/09/2005 and displayed until 15/06/2007
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 10/02/2004 and displayed until 20/09/2005
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text
Updated on 05/06/2003 and displayed until 10/02/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  testosterone