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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: 20/12/2011
SPC Cervarix

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 20/12/2011 and displayed until Current
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 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.1  for use from the age of 9 years
4.2  Paediatric population: ....not recommended in girls below 9 year ...
5.1 Prophylactic efficacy against HPV-16/18 infection in population naive to oncogenic HPV types

Immune response to Cervarix after the primary vaccination course

Persistence of immune response to Cervarix

Bridging the efficacy of Cervarix from young adults women to adolescents
10.  Updated date
Updated on 13/09/2011 and displayed until 20/12/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
5.1  Significant changes to include the HPV008 48 month Final Analysis data

10.  Updated with 26 August 2011
Updated on 04/03/2011 and displayed until 13/09/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5 - Pharmacological Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.5 Changes associated with Co-administration with Engerix B and some minor administrative/typo changes
5.1 Changes associated with Long Term Follow-Up data
10. new date 23 Feburary 2011
Updated on 15/10/2010 and displayed until 04/03/2011
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   14-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - removal of black triangle
Updated on 24/08/2010 and displayed until 15/10/2010
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 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.1  Expansion of indication, to include certain oncogenic HPV types (xref. 4.4 and 5.1)
4.2  Update to reflect flexibility of second and third doses
4.4  Update consequential to other changes
4.6  Update to numbers
5.1  Significantly updated following final analysis of study HPV-008, including updates on efficacy against vaccine HPV types, cross-protective efficacy against non-vaccine HPV types, and immune response updates. Also evidence of anamnestic response (from study HPV-024).
10.  Date of approval of latest changes
Updated on 14/06/2010 and displayed until 24/08/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 5.1 - Update SmPC 5.1 with immunogenicity data from HPV-023

Section 6.6 - Update of SmPC 6.6 to ensure instructions match correct pictures

Section 10 - Updated to date of Commission Decision
Updated on 10/12/2009 and displayed until 14/06/2010
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Updated to include a warning about syncope

Section 4.5 - New information on co-administration with a combined hepatitis A + B vaccine

Section 4.8 - Post-marketing undesirable effects added

Section 6.6 - Updated to include illustrated instructions for use of the pre-filled syringe.

Section 10 - Approval Date
Updated on 14/08/2009 and displayed until 10/12/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.5 - Two new paragraphs under " Use with other vaccines"
Section 10 - Date 24 July 2009
Updated on 08/05/2009 and displayed until 14/08/2009
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
  • Addition of link to EMEA website
Date of revision of text on the SPC:   22-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 6.3 - Shelf life extended. Addition of cold chain break information
Section 10 - Updated
Section 11 - Reference to EMEA website for further information
Updated on 02/09/2008 and displayed until 08/05/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
  • Change to section 4.1 - Therapeutic indications
Date of revision of text on the SPC:   13-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.1 - rewording of the indication statement including reference to 'premalignant cervical leesions'

Section 5.1 - update with information on long term data, update to pharmacotherapeutic group and explanation of term 'premalignant cervical lesions'

Section 10 - date of Commission Decision
Updated on 24/09/2007 and displayed until 02/09/2008
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  human papillomavirus vaccine