Pharmacia Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

Summary of Product Characteristics last updated on the eMC: 03/09/2009
SPC Estracyt Capsules

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 03/09/2009 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   13-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided
Updated on 24/11/2008 and displayed until 03/09/2009
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   13-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



-          section 4.4 – co-administration with vaccines

-          section 4.8 - Reported reactions arranged according to MedDRA System Organ System

-          section 5.1 – addition of ATC code

Updated on 26/08/2008 and displayed until 24/11/2008
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   14-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section3. Pharmaceutical Form – addition of ‘White, hard’, gelatine capsules.
Updated on 26/06/2008 and displayed until 26/08/2008
Reasons for adding or updating:
  • Change of inactive ingredient
Date of revision of text on the SPC:   01-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided
Updated on 07/08/2007 and displayed until 26/06/2008
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

 
Section 4.1 – Change in the name of polyoestradiol (Ban) to polyestradiol (INN)
 
Section 10 – Change in the date of revision
Updated on 18/07/2007 and displayed until 07/08/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7.0 – Marketing Authorisation Holder

Updated on 03/06/2004 and displayed until 18/07/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 23/04/2003 and displayed until 03/06/2004
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 10/07/2002 and displayed until 23/04/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 04/07/2002 and displayed until 10/07/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 04/03/2002 and displayed until 04/07/2002
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/08/2001 and displayed until 04/03/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 10/07/2001 and displayed until 20/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 10/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   estramustine sodium phosphate