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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

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: 12/01/2012
SPC Fendrix

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 12/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.4  Warning of syncope

10   19 December 2011
Updated on 03/09/2010 and displayed until 12/01/2012
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.1 addition of : in adolescents and adults from the age of 15 years onwards
4.2 addition of: Paediatric population
4.6 addition of: Fertility

4.8 addition of : Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness  have also been reported very rarely with hepatitis B vaccines


10.  28 July 2010

 
Updated on 10/05/2010 and displayed until 03/09/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   10-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - Deletion "of Fendrix"

Section 3 - moving warnings around

Section 4.4 - moving warnings around

Section 9 - Addition of renewal date

Section 10 - Date Change
Updated on 16/12/2009 and displayed until 10/05/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   02-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


section 4.4 - Removal of thiomersal statement
Updated on 19/03/2009 and displayed until 16/12/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.3 - Preclinical Safety Data
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   02-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - For a full list of excipients, see section 6.1

Section 4.2 - Minor formatting changes

 

Section 4.4 - Updated header "Special warnings and

special precautions for use"

Section 4.8 - New ADRs added

 

 

 

Section 5.1 - Minor formatting changes

 

 

Section 5.3 - Change "preclinical" to "non-clinical" and added cross section reference.

 

 

Section 6.6 - Updated header to "Special precautions for disposal and other handling"

 

 

 
Updated on 03/11/2008 and displayed until 19/03/2009
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   02-Feb-2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of Black Triangle
Updated on 29/09/2005 and displayed until 03/11/2008
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 29/09/2005 and displayed until 29/09/2005
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  hepatitis b antigen