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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: 03/04/2012
SPC Privigen 100mg/ml solution for infusion

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 03/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Removal of Black Triangle
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   19-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Virtually the whole SmPC was revised during the procedure to update the haemolysis warning in section 4.4. The black triangle has also been removed. 
Updated on 22/09/2010 and displayed until 03/04/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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 5.2 - Pharmacokinetic Properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Removal of Black Triangle
Date of revision of text on the SPC:   26-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
The changes fall into 4 categories:
1) The black triangle has been removed from the SmPC as this is no longer a requirement, but it remains on the promotional material until further notice. 
2) Changes to sections 5.1 & 5.2 are corrections from a previously approved variation
3) Changes to sections 4.2, 4.4, 6.2, 6.3 & 6.6 relate to a variation to include 5% glucose solution as a diluent if dilution is required
4) Changes to sections 4.4 & 4.8 relate to a variation to amend haemolysis wording 
Updated on 04/05/2010 and displayed until 22/09/2010
Reasons for adding or updating:
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 date of revision of the text
  • Addition of link to EMEA website
Date of revision of text on the SPC:   20-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to section 6.2 to remove reference to section 6.6 and change the European Medicines Agency details.
Updated on 12/02/2010 and displayed until 04/05/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   YES

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 25/09/2009 and displayed until 12/02/2010
Reasons for adding or updating:
  • Introduction of new pack/pack size
Date of revision of text on the SPC:   21-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Addition of 2.5g pack size
Updated on 12/06/2009 and displayed until 25/09/2009
Reasons for adding or updating:
  • Introduction of new pack/pack size
Date of revision of text on the SPC:   07-May-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Addition of 2.5g vial
Updated on 04/03/2009 and displayed until 12/06/2009
Reasons for adding or updating:
  • Addition of Black Triangle
Date of revision of text on the SPC:   25-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Addition of black triangle
Updated on 17/12/2008 and displayed until 04/03/2009
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

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

Active Ingredients/Generics

 
  human normal immunoglobulin