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Sanofi Pasteur MSD Limited
Mallards Reach, Bridge Avenue, Maidenhead, Berkshire, SL6 1QP
Telephone: +44 (0)1628 785 291
Fax: +44 (0)1628 671 722
Medical Information Direct Line: +44 (0)1628 587 693
Medical Information e-mail: medinfo@spmsd.com
Medical Information Fax: +44 (0)1628 635 072
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Summary of Product Characteristics last updated on the eMC: 25/09/2009
SPC GARDASIL

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 25/09/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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:   01-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Reference to 'subjects' has been amended to read 'individuals' throughout the SmPC.

Change to section 4.2 - Posology and method of administration

Paediatric population: Gardasil is not recommended for use in children below 9 years of age due to insufficient data on immunogenicity, safety and efficacy (see section 5.1).

Has been amended to read:

Paediatric population: There is no experience with the use of Gardasil in children below 9 years of age (see section 5.1).

 

Change to section 4.4 - Special warnings & precautions for use

Addition of the following information:

 

Gardasil is for prophylactic use only and has no effect on active HPV infections or established clinical disease.

 

Gardasil does not prevent lesions due to a vaccine HPV type in women already infected with that HPV type at the time of vaccination (see section 5.1).

 

The use of Gardasil in adult women should take into consideration the variability of HPV type prevalence in different geographical areas.  In the clinical study of adult women (24 to 45 years of age), no statistically significant vaccine efficacy was observed after 2.2 years of follow-up in the full analysis set that includes women regardless of baseline HPV status (see section 5.1). The decision to vaccinate an individual woman 27 to 45 years old should take into account her risk for previous HPV exposure and her potential benefit from vaccination.

 

Change to section 4.5 - Interactions with other medicaments

Update to the numbers of mid-adult women using hormonal contraceptives.

 

Change to section 4.6 - Pregnancy and lactation

Update to the numbers of women in the clinical development program that reported pregnancy.

 

Change to section 4.8 - Undesirable effects

Update to the numbers in the safety population.

The inclusion of the adverse reaction pain in the extremity as common

 

Change to section 5.1 - Pharmacodynamic properties

Update of efficacy in women 16 through 26 years and addition of data regarding efficacy in women 24 through 45 years.

 

Update to immunogenicity.

 

Change to section 10 - Date of revision to 09/2009

 
Updated on 12/08/2009 and displayed until 25/09/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   28-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


4.5 - Addition on concomitant use with Repevax/other vaccines

4.8 - Information on clinical trials involving concomitant use of Repevax with Gardasil
Updated on 25/06/2009 and displayed until 12/08/2009
Reasons for adding or updating:
  • 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:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.8 - addition of 'Chills'
Updated on 18/03/2009 and displayed until 25/06/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.8 - Updates to undesirable effects
Updated on 05/11/2008 and displayed until 18/03/2009
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:   01-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change to section 4.4

Addition of warning, fainting (syncope) may follow any vaccination.  Vaccinees should be observed for approximately 15 minutes after administration.

 

Change to section 4.8

Addition of side effects from post marketing experience, nausea, vomiting, arthralgia, myalgia, asthenia, fatigue and malaise.
Updated on 15/09/2008 and displayed until 05/11/2008
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.4 – Special warnings and precautions for use – Update to protection offered by Gardasil

Gardasil will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to some limited extent against diseases caused by certain related HPV types.

 

Gardasil will not provide protection against every HPV type.

 

Section 5.1 Update to data

Inclusion of data relating to cross protection efficacy.
Updated on 08/08/2008 and displayed until 15/09/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.1 - Therapeutic indications
  • 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 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   01-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.1 – Indication – expansion of the indication,

Gardasil is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18 (see section 5.1).

Section 4.2 – Rewording of the route of administration paragraph.

Subcutaneous and intradermal routes of administration have not been studied and are therefore not recommended.

Section 4.4 – Addition of statement regarding interchangeability of vaccine

The interchangeability of the vaccine with other HPV vaccines, has not been studied and is therefore not recommended.

Section 4.6 – Update to data

Update to the numbers involved in the clinical development program and the outcomes.

Section 4.8 – Update to data

Rewording of the side effect ; ‘bleeding’ changed to ‘bruising’

Addition of side effects; Lymphadenopathy, Gullain Barre syndrome and headache.

Section 5.1 – Update to data

Following analysis of 3 year clinical data, the data has been updated and added to reflect the results.

Section 6.4 – Grammatical correction

 
Updated on 26/02/2008 and displayed until 08/08/2008
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to section 6.5 to include 20 dose pack of prefilled syringes and change to section 8 to include 20 dose pack licence numbers.
Updated on 13/08/2007 and displayed until 26/02/2008
Reasons for adding or updating:
  • 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:   07/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to section 4.8: Addition of post marketing safety data.

Change to section 10: Date changed to July 07
Updated on 24/07/2007 and displayed until 13/08/2007
Reasons for adding or updating:
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 6.6 has been modified to improve clarity of the instructions for use of the needle guard (safety device).
Updated on 15/02/2007 and displayed until 24/07/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 17/10/2006 and displayed until 15/02/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  human papillomavirus vaccine


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