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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: 20/04/2012
SPC Havrix Monodose Vaccine

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 20/04/2012 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:   16-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4 warning of syncope
10  16 April 2012
Updated on 22/08/2011 and displayed until 20/04/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.8  Update to reflect safety information obtained through clinical studies and post-marketing surveillance.
4.9  Update re overdosage
10.  Updated with new date of revision of text
Updated on 08/09/2009 and displayed until 22/08/2011
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
6.1 - removal of 2 phenoxyethanol (previously the second excipient on the list)
10 -Approval date 1 April 2009
Updated on 30/04/2009 and displayed until 08/09/2009
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Mar-2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.1 - List of excipients: '2-phenoxyethanol' re-inserted

 

Section 10 - Replaced with previous approval date
Updated on 03/04/2009 and displayed until 30/04/2009
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.1 - List of excipients: '2-phenoxyethanl' has been deleted

Section 10 - New approval date 1 April 2009
Updated on 05/04/2006 and displayed until 03/04/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 10/03/2003 and displayed until 05/04/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 26/07/2002 and displayed until 10/03/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 31/01/2002 and displayed until 26/07/2002
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 22/06/2001 and displayed until 31/01/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 01/09/2000 and displayed until 22/06/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 01/09/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
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