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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: 19/03/2012
SPC Microgynon 30

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 19/03/2012 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:   13-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes to the SmPC are:

  •  Section 7, removal of the trading style.
Updated on 07/03/2012 and displayed until 19/03/2012
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Extra statutory information
Date of revision of text on the SPC:   14-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes to the SmPC are:

·        Overall update of the SmPC in line with the Company Core Datasheet and Core Safety Profile (as agreed on a European level).

·        Section 10, Date of revision of the text.

Updated on 28/07/2011 and displayed until 07/03/2012
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes to the SmPC are:

Section 4.6 (Pregnancy & Lactation) has been updated to bring it into line with the CCDS text.
Updated on 09/11/2009 and displayed until 28/07/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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:   14-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes to the SmPC are:
Section 2 (Qualitative and quantitative composition), lactose and sucrose content and a reference to see Section 6.1 for the full list of excipients.
Section 6.6 (Special precautions for disposal) has been changed to 'No special requirements'.
Section 10 (Date of revision of the text) has been updated.

Updated on 18/03/2009 and displayed until 09/11/2009
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
  • Improved Electronic Presentation
Date of revision of text on the SPC:   05-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 9 - the renewal date is now 5 December 2008
Section 10 - revision date is also 5 December 2008

Other editorial changes have been made during renewal
Updated on 26/08/2008 and displayed until 18/03/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
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
Correction of spelling error in Section 4.3, point 8 - "severs" to "severe". 
Updated on 23/07/2008 and displayed until 26/08/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
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
None provided
Updated on 27/06/2008 and displayed until 23/07/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • 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-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 Mayn 2008

Section 7: MAH now Bayer plc
Section 8: Licence number is now PL 00010/ 0545
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 09/02/2005 and displayed until 27/06/2008
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 15/05/2001 and displayed until 09/02/2005
Reasons for adding or updating:
  • No reasons supplied
Updated on 11/04/2001 and displayed until 15/05/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 21/08/2000 and displayed until 11/04/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 21/08/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ethinylestradiol
  levonorgestrel