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Novo Nordisk Limited
Broadfield Park, Brighton Road, Crawley, West Sussex, RH11 9RT
Telephone: +44 (0)1293 613555
Fax: +44 (0)1293 613535
Medical Information Direct Line: +44 (0)845 600 5055
Medical Information e-mail: ukmedicalinfo@novonordisk.com
Customer Care direct line: +44 (0)845 600 5055
Medical Information Fax: +44 (0)1293 613211

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: 26/08/2011
SPC Vagifem 25 micrograms film-coated tablets

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 26/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


10        DATE OF REVISION OF THE TEXT

 

06/10/2010
Updated on 09/04/2009 and displayed until 26/08/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   24-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2.1 - Removal of sentence 'Treatment should be discontinued after about three months to assess whether further therapy is necessary.'
Section 9 - Addition of  recent date of renewal 'Authorisation renewed 10/03/2009'.
Updated on 07/11/2008 and displayed until 09/04/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5 - Pharmacological Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4 Special warnings and Special precautions before use
Clincial particilars now indue the Womens' Health Initiative and Million Women Studies

5. Pharmalogical Properties have been updated.

10. SmPC is verion 4 and revision date is September 2008
Updated on 12/03/2002 and displayed until 07/11/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/08/2001 and displayed until 12/03/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 08/08/2001 and displayed until 22/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 08/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  estradiol hemihydrate