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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: 16/04/2012
SPC Triadene

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 16/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The key changes are:
  • To remove the trading style from section 7 of the SmPC. 
Updated on 13/05/2011 and displayed until 16/04/2012
Reasons for adding or updating:
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The key change is:

Section 6.6

 

has been updated in line with EC Guideline and now states 'No special requirements

 
Updated on 07/10/2010 and displayed until 13/05/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   02-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The key changes are:

 

  • Section 6.5 of the SmPC has been updated to reflect the approval of the change of shape of the blister from a circular to a rectangular one.
Updated on 17/03/2009 and displayed until 07/10/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Improved Electronic Presentation
Date of revision of text on the SPC:   02-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The main changes are editorial - which arose during renewal 

Revision date is now 2 March 2009
Updated on 25/06/2008 and displayed until 17/03/2009
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May 2008.

Section 7: MAH now Bayer plc
Section 8: Licence number is now PL 00010/ 0563
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 22/09/2004 and displayed until 25/06/2008
Reasons for adding or updating:
  • Change from the BAN of the active substance to the rINN
Updated on 17/01/2002 and displayed until 22/09/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 09/01/2002 and displayed until 17/01/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 19/07/2001 and displayed until 09/01/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 22/11/2000 and displayed until 19/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 22/11/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ethinylestradiol
  gestodene