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Grifols UK Ltd
Byron House, Cambridge Business Park, Cowley Road, Cambridge, Cambridgeshire, CB4 0WZ, UK
Telephone: +44 (0)1223 395 700
Fax: +44 (0)1223 395 766
WWW: http://www.grifols.com
Medical Information e-mail: medinfo.uk@grifols.com
Customer Care direct line: +44 (0)1223 395 777

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: 16/06/2011
SPC Flebogamma DIF 50mg/ml

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 16/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Product name has changed from Flebogammadif® 50mg/ml to Flebogamma® DIF 50mg/ml.
Updated on 27/11/2009 and displayed until 16/06/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Part of the wording for Section 4.4 "Special warnings about excipients" has been changed from:

Special precautions should be taken with babies and young children because this fructose intolerance may not yet be diagnosed and may be fatal.

To:

In babies and young children hereditary fructose intolerance may not yet be diagnosed and may be fatal, thus, they should not receive sorbitol-containing solutions.

In other patients in case of inadvertent application and suspicion of fructose intolerance the infusion has to be stopped immediately, normal glycemia has to be re-established and organ function has to be stabilized by means of intensive care.

In Section 8 the part of the MA numbers listed were incorrect.  e.g:

Flebogammadif  0.5g/ml (10ml)   EU/1/07/404/001 should read:

Flebogammadif  50mg/ml (10ml)     EU/1/07/404/001

This change to the MA numbers only affects the SmPC on the emc website - the paper version is correct.
Updated on 10/09/2009 and displayed until 27/11/2009
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