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Cervarix

Last Updated on eMC 15-Aug-2016 View document  | GlaxoSmithKline UK Contact details

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 15-Aug-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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

Date of revision of text on the SPC: 29-Jul-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

• Update to section 4.1 (indications) to include prevention of premalignant anal lesions and anal cancers causally related to HPV.
• Update to section 4.2 (posology/administration) to replace reference to “girls” with “children” and include instructions not to administer intravascularly or intradermally, or to co-administer with another injectable vaccine at the same site.
• Update to section 4.3 (contraindications) to remove instruction to postpone administration in subjects suffering from acute febrile illness. NB – this text is moved to section 4.4
• Update to section 4.4 (warnings & precautions) to insert instruction to postpone administration in subjects suffering from acute febrile illness.
• Update to section 4.5 (interactions) to remove detail related to use with immunosuppressive medicines. Instruction inserted to refer to section 4.4
• Update to section 4.7 (driving/using machines) to include statement that undesirable effects (section 4.8) may temporarily affect ability to drive/use machines.
• Update to section 4.8 (undesirable effects) to include reference to additional clinical studies in males. Section reformatted into tabular format (per QRD).
• Update to section 5.1 (pharmacodynamics) to include information related to anal cancers and neoplasia.
• Update to section 6.3 (shelf life) to include instruction to discard vaccine after certain period.

Updated on 10-Mar-2015 and displayed until 15-Aug-2016

Reasons for adding or updating:

  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 26-Feb-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Description of change to SPC:

Section 4.6  - updated to reflect recently available data

Updated on 08-Dec-2014 and displayed until 10-Mar-2015

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC: 21-Nov-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update sections 4.2 and 5.1 of the SPC to extend the current 2-dose 0, 6 months schedule to 0, 5-13 months schedule.

Updated on 03-Sep-2014 and displayed until 08-Dec-2014

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • 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: 22-Aug-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update section 4.4 to delete the sentence “The decision to vaccinate an individual woman should take into account her risk for previous HPV exposure and her potential benefit from vaccination”  in line with changes requested by the CHMP

Section 4.8 has been updated with the addition of HPRA details for adverse reporting.

Updated on 07-Jan-2014 and displayed until 03-Sep-2014

Reasons for adding or updating:

  • 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: 18-Dec-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.2  Data on 2 dose schedule
5.1  Data on 2 dose schedule
10   Updated with new date of revision of text

Updated on 09-Jul-2013 and displayed until 07-Jan-2014

Reasons for adding or updating:

  • 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 10 - Date of revision of the text

Date of revision of text on the SPC: 28-Jun-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.4 Update with data on HIV infectd subjects
4.8 QRD 9 - Reporting of suspected adverse reactions
5.1 Update with data on HIV infected subjects
10  Updated with new date of revision of text

Updated on 08-Apr-2013 and displayed until 09-Jul-2013

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • 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: 27-Mar-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.1 Vulvar and vaginal lesions added to SPC indication statement

5.1  Data on vulvar and vaginal lesions added

10   Updated with new date of revision of text

Updated on 26-Sep-2012 and displayed until 08-Apr-2013

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.2 - Pharmacokinetic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 17-Sep-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:


  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.2 - Pharmacokinetic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Updated on 20-Dec-2011 and displayed until 26-Sep-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 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-Sep-2011 and displayed until 20-Dec-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-Mar-2011 and displayed until 13-Sep-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-Oct-2010 and displayed until 04-Mar-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-Aug-2010 and displayed until 15-Oct-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-Jun-2010 and displayed until 24-Aug-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-Dec-2009 and displayed until 14-Jun-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-Aug-2009 and displayed until 10-Dec-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-May-2009 and displayed until 14-Aug-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-Sep-2008 and displayed until 08-May-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-Sep-2007 and displayed until 02-Sep-2008

Reasons for adding or updating:

  • New SPC for new product

Company contact details

GlaxoSmithKline UK

Company image
Address

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Fax

+44 (0)208 990 4328

Medical Information e-mail
Telephone

0800 221 441

E-mail
Customer Care direct line

0800 221 441

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?

Active ingredients

human papillomavirus vaccine

Legal categories

POM - Prescription Only Medicine

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