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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

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Summary of Product Characteristics last updated on the eMC: 25/01/2012
SPC Typherix

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 25/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   23-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.4  warning of syncope

10  revision date
Updated on 10/11/2009 and displayed until 25/01/2012
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:   03-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

section 6.3 - Shelf life increase from 2 to 3 years

section 10 - New revision date: 3/11/09
Updated on 02/09/2008 and displayed until 10/11/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
  • Change to section 4.3 - Contraindications
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   07-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Changes throughout the SmPC to bring it in line with the new EU guidelinees on SMPCs.  Significant change to Section 4.8 to include the frequencies of the undesirable effects.

Section 4.3 - Administration guidance if suffering from acute febrile illness (previously in section 4.4)

Section 4.8 - Addition of frequencies of the undesirable effects

Section 6.4 - Updated statements on storage

Section 10 - Approval date

Updated on 22/08/2006 and displayed until 02/09/2008
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   08/2003
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441

Updated on 02/08/2005 and displayed until 22/08/2006
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 22/10/2004 and displayed until 02/08/2005
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 19/12/2002 and displayed until 22/10/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Correction of spelling/typing errors
Updated on 08/11/2002 and displayed until 19/12/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/10/2002 and displayed until 08/11/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 30/09/2002 and displayed until 25/10/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 26/09/2002 and displayed until 30/09/2002
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 14/03/2002 and displayed until 26/09/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 13/08/2001 and displayed until 14/03/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 13/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
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