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

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