GARDASIL
- Name:
GARDASIL
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/05/19
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MSD Ireland (Human Health) Limited
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 10 May 2019 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 10 May 2019 SmPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 5.1 updated with long term follow-up data
Updated on 14 August 2018 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Updated on 5 July 2018 SmPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 5.1 updated with long term extension study data
Updated on 5 July 2018 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 22 May 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 22 May 2017 SmPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 3 March 2017 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 2 March 2017 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 2 March 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 17 January 2017 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 27 October 2016 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 4 May 2016 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Combined SPC to include vial and prefilled syringe.
In section 4.4, update of interchangeability 'immunogenicity or efficacy data to support change during vaccination with Gardasil to other HPV vaccines which do not cover the same HPV types. Therefore, it is important that the same vaccine should be prescribed for the whole dose regimen'.
In section 5.1, addition of Efficacy in women 16 through 26 years: The primary analyses of efficacy, with respect to vaccine HPV types (HPV 6, 11, 16, and 18), were conducted in the per-protocol efficacy (PPE) population (i.e. all 3 vaccinations within 1 year of enrollment, no major protocol deviations and naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7)).
The inclusion of 10 year long term follow up data for Gardasil.
In section 6.4, updated to revise 'Data from stability studies demonstrate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 42°C' (updated from 25°C to 42°C).
In section 6.5, combined details for both presentations.
In section 6.6, concise bullet points providing clear instructions for Special precautions for disposal and other handling.
In section 10, revision date updated to 04/2016.
Updated on 10 June 2015 SmPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.8 include adverse reaction reporting information
In section 6.4 added out of fridge storage condition statement to read: Gardasil should be administered as soon as possible after being removed from the refrigerator. Stability data indicate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 25°C. At the end of this period Gardasil should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.
In section 10, date of revision 05/2015
Updated on 9 December 2014 PIL
Reasons for updating
- Change to side-effects
Updated on 9 December 2014 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 addition of Acute disseminated encephalomyelitis, adverse reaction reporting
Section 5.1 Inclusion of effectiveness results and Immunogenicity results from LTFU studies (P015, P018, P019 and P020).
Section 10 date of revision 6 June 2014 updated to 10/2014
Updated on 20 June 2014 PIL
Reasons for updating
- Change to, or new use for medicine
Updated on 20 June 2014 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of premalignant anal lesions, anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types to section therapeutic indications
addition of Long-term follow-up studies are currently ongoing to determine the duration of protection. (see section 5.1). in section warning and precaution
Addition of data related to premalignant anal lesions and anal cancers in Pharmacodynamic properties
Updated on 16 April 2014 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to information about pregnancy or lactation
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 3 April 2014 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
section 2: QUALITATIVE AND QUANTITATIVE COMPOSITION
for the adjuvant, change the unit from mircogram to milligram
section 4.2 posology and methode of administration:
description of an alternative schedule in 2 doses.
section 4.8 undersirable effects
addition of the Reporting of suspected adverse reactions statement
section 5.1Pharmacodynamic properties
addition of paragraph about Immune Responses to Gardasil using a 2-dose schedule in individuals 9-13 years of age
Updated on 14 November 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 14 November 2012 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
(...)Syncope (fainting), sometimes associated with falling, can occur following, or even before, any vaccination, especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery. Therefore, vaccinees should be observed for approximately 15 minutes after vaccine administration. It is important that procedures are in place to avoid injury from faints.
(...)
Updated on 24 May 2012 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 16 May 2012 PIL
Reasons for updating
- Change to side-effects
Updated on 16 January 2012 PIL
Reasons for updating
- Change to side-effects
Updated on 13 January 2012 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 31 August 2011 SmPC
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of the SmpC to be in line with the SmPC guideline
Update of the Study for genital warts in section 5.1.
Updated on 16 August 2011 PIL
Reasons for updating
- Change to side-effects
- Change to information about driving or using machinery
- Change to how the medicine works
- Changes to therapeutic indications
Updated on 2 September 2010 PIL
Reasons for updating
- Change to, or new use for medicine
Updated on 1 September 2010 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Added efficacy in women
Updated on 10 June 2010 PIL
Reasons for updating
- Change to side-effects
Updated on 2 June 2010 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 2 October 2009 SmPC
Reasons for 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 4.6 - 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
- Change to section 4.2 - Posology and method of administration
Legal category: Product subject to medical prescription which may not be renewed (A)
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 28 September 2009 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 12 August 2009 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
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 GardasilUpdated on 4 August 2009 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to dosage and administration
Updated on 2 July 2009 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 June 2009 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 19 June 2009 PIL
Reasons for updating
- Improved electronic presentation
Updated on 18 June 2009 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 12 March 2009 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 - updates to undesirable efects
Updated on 11 March 2009 PIL
Reasons for updating
- Improved electronic presentation
Updated on 10 March 2009 SmPC
Reasons for updating
- 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 March 2009 PIL
Reasons for updating
- Change to side-effects
Updated on 5 December 2008 PIL
Reasons for updating
- Change to side-effects
- Improved electronic presentation
- Addition of marketing authorisation holder
- Change to date of revision
Updated on 5 November 2008 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 5 November 2008 SmPC
Reasons for 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
Legal category: Product subject to medical prescription which may not be renewed (A)
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 September 2008 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
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 15 September 2008 PIL
Reasons for updating
- Changes to therapeutic indications
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 8 August 2008 SmPC
Reasons for 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 6.4 - Special precautions for storage
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to
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 8 August 2008 PIL
Reasons for updating
- Change to side-effects
- Changes to therapeutic indications
Updated on 3 July 2008 PIL
Reasons for updating
- Improved electronic presentation
Updated on 3 July 2008 PIL
Reasons for updating
- Change to date of revision
- Change to side-effects
- Change to, or new use for medicine
Updated on 28 May 2008 PIL
Reasons for updating
- Addition of marketing authorisation holder
Updated on 15 August 2007 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 15 August 2007 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
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 2007
Updated on 24 July 2007 SmPC
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may not be renewed (A)
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 12 July 2007 PIL
Reasons for updating
- Improved electronic presentation
Updated on 16 February 2007 PIL
Reasons for updating
- Improved electronic presentation
Updated on 15 February 2007 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 17 October 2006 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 17 October 2006 PIL
Reasons for updating
- New PIL for new product