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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: 13/05/2011
SPC Femodette

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 13/05/2011 and displayed until Current
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 30/06/2009 and displayed until 13/05/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • 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 6.5 (Nature and contents of container) – the text has been updated from:

 

     'The blister packs consist of hard tempered aluminium foil of thickness 20µm and transparent PVC film of thickness 250µm. 

           

            Presentation

            Cartons containing 1 or 3 blister memo-packs

            Each memo-pack contains 21 tablets'.

 

to:


            'Primary containers:

The blister packs consist of hard tempered aluminium foil of thickness 20m and transparent PVC film of thickness 250m.

 

Presentation:

Blister calendar pack contaiing 21 tablets.'

 

·       Section 9 (Date of first authorisation / Renewal of the authorisation) has been updated to reflect the Renewal approval date of 06 March 2009. 

 

·       Section 10 (Date of revision of the text) has been updated to reflect the Renewal approval date of 06 March 2009. 

 
Updated on 28/05/2008 and displayed until 30/06/2009
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 7 - Marketing Authorisation Holder
  • 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/ 0531
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008 
Updated on 08/01/2002 and displayed until 28/05/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 25/07/2001 and displayed until 08/01/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 21/08/2000 and displayed until 25/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ethinylestradiol
  gestodene