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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: 12/11/2010
SPC Dianette

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 12/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   05-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes are:

  • The length of use statement has been moved from Section 4.1 ‘Therapeutic indications’ of the Dianette SmPC to section 4.2 ‘Posology and method of administration'.
Updated on 17/06/2010 and displayed until 12/11/2010
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 10 date of revision of the text
Date of revision of text on the SPC:   27-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 ( Qualatative and quantative composition) - has been amended to reflect current standard terminology in line with the European Guideline on the Summary of Product Characteristics

Section 4.4 ( Special warnings) As the Dianette tablets contain lactose and sucrose the warning statements for lactose and sucrose from the Notice to Applicants; ENTR/F2/BL D (2003) were added to Section 4.4 of the SmPC.

Section 10 ( Revision date) - this is now 27 May 2010
Updated on 28/05/2008 and displayed until 17/06/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • 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
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
The MA Holder has changed from Schering Health Care Limited to Bayer plc. 
Updated on 10/07/2007 and displayed until 28/05/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • 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
The following sections have been updated with revised depression warnings:
Section 4.4 (Special warnings and special precautions for use)
Section 4.8 (Undesirable effects)
Section 10 (Date of revision of the text) - this has been updated to 26th June 2007. 
Updated on 22/09/2004 and displayed until 10/07/2007
Reasons for adding or updating:
  • Change from the BAN of the active substance to the rINN
Updated on 25/09/2003 and displayed until 22/09/2004
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 24/09/2003 and displayed until 25/09/2003
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 14/11/2002 and displayed until 24/09/2003
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 09/08/2001 and displayed until 14/11/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 12/09/2000 and displayed until 09/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 10/07/2000 and displayed until 12/09/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 10/07/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  cyproterone acetate
  ethinylestradiol