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Merck Serono

Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
Telephone: +44 (0)208 818 7200
Fax: +44 (0)208 818 7267
Medical Information Direct Line: +44 (0)208 818 7373
Medical Information e-mail: medinfo.uk@merckserono.net
Medical Information Fax: +44 (0)208 818 7274

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: 03/01/2012
SPC Femseven 50, 75, 100

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 03/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


  • In section 6.3, the shelf-life has been changed from 2 to 3 years.
  • Updated on 09/09/2011 and displayed until 03/01/2012
    Reasons for adding or updating:
    • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
    Date of revision of text on the SPC:   18-Apr-2008
    Legal Category:   POM
    Black Triangle (CHM):   NO

    Free-text change information supplied by the pharmaceutical company

    The following section updated:

    9.       Date of first authorization/renewal of authorization

     

              14 December 2010

    Updated on 04/06/2008 and displayed until 09/09/2011
    Reasons for adding or updating:
    • Change to section 7 - Marketing Authorisation Holder
    Date of revision of text on the SPC:   18-Apr-2008
    Legal Category:   POM
    Black Triangle (CHM):   NO

    Free-text change information supplied by the pharmaceutical company

    Change to name and address of MA Holder - section 7. The following is the updated information:

    7.       Marketing authorization holder

     

    Merck Serono Ltd

    Bedfont Cross

    Stanwell Road

    Feltham

    Middlesex

    TW14 8NX

    UK

    Updated on 24/06/2004 and displayed until 04/06/2008
    Reasons for adding or updating:
    • Change to section 4.1 - Therapeutic Indications
    • Change to section 4.3 - Contra-indications
    • Change to section 4.4 - Special Warnings and Precautions for Use
    • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
    • Change to section 4.8 - Undesirable Effects
    • Change to section 5.1 - Pharmacodynamic Properties
    • Change to section 5.2 - Pharmacokinetic Properties
    Updated on 19/02/2002 and displayed until 24/06/2004
    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 4.8 - Undesirable Effects
    • Change to section 5.1 - Pharmacodynamic Properties
    • Change to section 9 - Date of Renewal of Authorisation
    Updated on 16/07/2001 and displayed until 19/02/2002
    Reasons for adding or updating:
    • Transferred from eMC version 1
    Updated on 01/03/2000 and displayed until 16/07/2001
    Reasons for adding or updating:
    • No reasons supplied
    Updated on 06/09/1999 and displayed until 01/03/2000
    Reasons for adding or updating:
    • No reasons supplied

    Active Ingredients/Generics

     
       estradiol hemihydrate