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CSL Behring UK Limited
Hayworth House, Market Place, Haywards Heath, West Sussex, RH16 1DB, UK
Telephone: +44 (0)1444 447 400
Fax: +44 (0)1444 447 403
WWW: http://www.cslbehring.co.uk
Medical Information Direct Line: +44 (0)1444 447 405
Medical Information e-mail: medinfo@cslbehring.com
Customer Care direct line: +44 (0)1444 447 402
Out of Hours contact: +44 (0)1444 447 405

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: 02/08/2011
SPC Beriplex P/N 250 & 500 IU

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 02/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   28-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Revision of virus safety warning in section 4.4 of SmPCs
Updated on 11/05/2010 and displayed until 02/08/2011
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   29-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 1: removal of black triangle
Updated on 03/02/2010 and displayed until 11/05/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
  • Change to joint SPC covering all presentations
Date of revision of text on the SPC:   31-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
'IU' has been added to the product names.
Updated on 04/03/2009 and displayed until 03/02/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 21/10/2008 and displayed until 04/03/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   01-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 2 - Protein S content has been updated to 12-38 IU/ml.
Updated on 09/09/2008 and displayed until 21/10/2008
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  factor IX
  factor II
  factor VII
  factor X
  protein c
  protein s