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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: 28/07/2011
SPC Logynon

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 28/07/2011 and displayed until Current
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:   18-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 13/05/2011 and displayed until 28/07/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

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

Section 2: ‘Qualitative and Quantitative Composition’ of the SmPC has been updated to reflect current standard terminology in line with the European Guideline on the Summary of Product Characteristics. There is a consequential change to section 4.4 with the addition of a 'Lactose and Sucrose Intolerance' warning; in line with the guidance in Notice to Applicants: ENTR/F2/BL D (2003).

Updated on 26/06/2009 and displayed until 13/05/2011
Reasons for adding or updating:
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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:   06-Mar-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 6.6 (Special precautions for disposal) 'No special requirements' has been added.
  • Section 9 (Date of first authorisation / Renewal of the Authorisation) has been updated to the Renewal date - 6th March 2009.
  • Section 10 (Date of revision of the text) has been updated to the Renewal date - 6th March 2009.
Updated on 27/06/2008 and displayed until 26/06/2009
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


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/ 0540
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 15/05/2001 and displayed until 27/06/2008
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 12/09/2000 and displayed until 11/04/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 12/09/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ethinylestradiol
  levonorgestrel