VARIVAX powder and solvent for suspension for injection in a pre-filled syringe
*Company:
MSD Ireland (Human Health) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 December 2023
File name
QRD-Varivax-LFT-II-0125-CRT-18122023.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 20 December 2023
File name
VARIVAX-IT-H-114-001-II-0125-SPC-IE-en-CRT.pdf
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 adverse events (Syncope)
Updated on 27 September 2022
File name
VARIVAX-IT-H-114-001-II-0119-SPC-IE-en-CRT Sep 2022.pdf
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
Removal of adverse events.
Updated on 27 September 2022
File name
QRD-Varivax-LFT-II-0119-19092022.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 15 February 2022
File name
VARIVAX-IT-H-114-001-IA-0117-G-SPC-IE-en-CRT Feb 2022.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Deletion of presentation with attached needle.
Updated on 15 February 2022
File name
QRD-Varivax-LFT-IA-0117G-07022022.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 30 July 2020
File name
QRD_Varivax_PIL_II106G_July 2020.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
- Change to name of medicinal product
- Change to information for healthcare professionals
Updated on 30 July 2020
File name
VARIVAX-IT-H-114-001-II-0106-G-SPC-IE-en-clean July 2020.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.2 - Incompatibilities
- 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 - Special precautions for disposal and other handling
- 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 July 2020
File name
QRD_Varivax_PIL_II106G_July 2020 (002).pdf.
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
- Change to name of medicinal product
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Previous upload not displaying published PIL, had to upload again due to technical error on this website
Updated on 30 July 2020
File name
QRD_Varivax_PIL_II106G_July 2020 (002).
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
- Change to name of medicinal product
- Change to information for healthcare professionals
Updated on 30 July 2020
File name
VARIVAX-IT-H-114-001-II-0106-G-SPC-IE-en-clean July 2020 (002).pdf.
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.2 - Incompatibilities
- 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 - Special precautions for disposal and other handling
- 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 1: product name amended to “VARIVAX powder and solvent for suspension for injection in a pre-filled syringe”
section 4.4: added headings on “Traceability”, “Sodium” and “Potassium”
Section 6.6: updated directions for vaccine preparation
Updated on 15 February 2019
File name
QRD_Varivax_PIL_WS098_IB100.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 22 November 2018
File name
Varivax_PIL_WS098_clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 November 2018
File name
VARIVAX-IT-H-114-001-WS098-SPC-IE-en-CRT Nov 2018.pdf
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
Section 4.8: Addition of text: “Complications of varicella from vaccine strain, including herpes zoster and disseminated disease such as aseptic meningitis and encephalitis, have been reported in immunocompromised or immunocompetent individuals.”
Updated on 14 August 2018
File name
QRD_Varivax_PIL_BRX_PRO (2).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Updated on 08 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 January 2018
Reasons for updating
- Change to section 1 - Name of medicinal product
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 1, hard brackets around "Varicella Vaccine (live)" have been removed.
Editorial changes have been made to other sections.
Updated on 05 January 2018
File name
PIL_10959_402.pdf
Reasons for updating
- New PIL for new product
Updated on 05 January 2018
Reasons for updating
- Correction of spelling/typing errors
- Improved presentation of PIL
Updated on 02 March 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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
SPC change details: New Marketing Authorisation Holder and MA Number following PA transfer to Merck Sharp & Dohme Ireland (Human Health) Limited
Updated on 01 March 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 March 2014
Reasons for updating
- Change to side-effects
Updated on 07 February 2014
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
Reporting of suspected adverse reactions paragraph has been updated following comment from the IMB after publishing the SPC following the approval of the variation.
Updated on 31 January 2014
Reasons for updating
- Change to side-effects
- Change to drug interactions
Updated on 02 January 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 6.2 - Incompatibilities
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
section 2: editorial change
section 4.5: editorial change
section 4.8: addition of the text "Necrotizing retinitis has been reported post-marketing in immunocompromised individuals."
and the description of reporting process for suspected adverse reactions in Ireland
section 6.2: replacement of "should" by "must".
Updated on 12 July 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 11 July 2013
Reasons for updating
- 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 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
The main changes to the SPC are as follows:
Section 4.3 Contraindications
The updated text (see below) clarifies the fact that that the contraindication applies to individuals with severe humoral or cellular immunodeficiency:
Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see section 4.4).
The contraindication below has been expanded to include the fact that pregnancy should be avoided for 1 month following vaccination:
Pregnancy. Furthermore, pregnancy should be avoided for 1 month following vaccination (see section 4.6).
Section 4.4 Special warnings and precautions for use
Information on the use of the product in children with HIV infection has now been moved to section 4.3 Contraindications (see above).
Section 4.4 has also been updated (see updated text below) to include patients with selected immune deficiencies and clarification added about immunocompromised patients receiving the vaccine .
Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (e.g., asymptomatic HIV subjects, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases).
Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent subjects; therefore, some of these patients may acquire varicella in case of contact, despite appropriate vaccine administration. These patients should be monitored carefully for signs of varicella.
The sub-heading, ‘Pregnancy and breastfeeding’ has been deleted and the information associated with the heading has now been moved to sections 4.3 Contraindications and 4.6 Fertility, pregnancy and lactation.
Section 4.6 Fertility, pregnancy and lactation
This section has been updated (see updated text below) to clarify that pregnant women should not be vaccinated with the product.
Pregnancy
Pregnant women should not be vaccinated with VARIVAX.
Studies have not been conducted with VARIVAX in pregnant women.
However, fetal damage has not been documented when varicella vaccines have been given to pregnant women.It is not known whether VARIVAX can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
Pregnancy should be avoided for 1 month following vaccination. Women who intend to become pregnant should be advised to delay.
Date of revision in Section 10 has been changed to June 2013.
Updated on 07 December 2012
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 4.8 Undesirable effects
The following sentence has been deleted from section 4.8 (Undesirable effects) section c Description of adverse events:
The long-term effect of varicella vaccine (live) (Oka/Merck strain) on the incidence of herpes zoster, particularly in those vaccinees exposed to wild-type varicella, is unknown at present.
The following text has been added to section 4.8 (Undesirable effects) section c Description of adverse events:
Active surveillance data in children vaccinated with varicella vaccine (live) (Oka/Merck strain) and followed for 14 years after vaccination showed no increase in the frequency of herpes zoster compared to children with prior wild-type varicella during the pre-vaccine era. However, the long-term effect of varicella vaccine (live) (Oka/Merck strain) on the incidence of herpes zoster is unknown at present (see section 5.1).
Section 5.1 Pharmacodynamics
The following text has been added at the end of this section:
Effectiveness of varicella vaccine (live) (Oka/Merck strain)
Observational studies of long-term effectiveness of VARIVAX
Surveillance data from two
In the first study, a long-term prospective cohort study, approximately 7,600 children vaccinated in 1995 with varicella vaccine in their second year of life were actively followed for 14 years in order to estimate the occurrence of varicella and herpes zoster. By the end of the study in 2009, 38% of the study children were known to have received a second dose of varicella vaccine. Of note, in
In a second long‑term surveillance study, five cross‑sectional surveys on varicella incidence, each from a random sample of approximately 8,000 children and adolescents 5 to 19 years of age, were conducted over 15 years, from 1995 (pre‑vaccine) through 2009. Results showed a gradual decline of varicella rates by an overall 90% to 95% (approximately 10‑ to 20‑fold) from 1995 to 2009 in all age groups, both in vaccinated and unvaccinated children and adolescents. In addition, a decrease by approximately 90% (approximately 10‑fold) in varicella hospitalization rates was observed in all age groups.
Updated on 02 November 2012
Reasons for updating
- Change to date of revision
- Changes to therapeutic indications
Updated on 01 November 2012
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.1 Therapeutic indications
addition of a new paragraph:
VARIVAX can be administered to infants from 9 months of age under special circumstances, such as to conform with national vaccination schedules or in outbreak situations (see sections 4.2, 4.5, and 5.1).
4.2 Posology and method of administration
addition of a new paragraph: in Posology
The use of VARIVAX should be based on official recommendations.
Individuals less than 9 months of age
VARIVAX should not be administered to individuals less than 9 months of age.
Individuals from 9 months of age
Individuals should receive two doses of VARIVAX to ensure optimal protection against varicella (see section 5.1).
Individuals from 9 to 12 months of age
In settings in which vaccination is initiated between 9 and 12 months of age, a second dose is needed and should be given after a minimum interval of 3 months (see section 5.1).
Individuals from 12 months to 12 years of age
For individuals from 12 months to 12 years of age, at least one month must elapse between the first and second dose (see section 5.1).
Addition of a new parapgraph and table in section 5.1 Pharmacodynamic properties
Updated on 27 July 2012
Reasons for updating
- Change to side-effects
Updated on 26 July 2012
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 20 July 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - 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 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- 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
As a reminder, the purpose of this variation is to update the Summary of Product Characteristics
(SmPC) of Varivax to refiect changes that have been made to the Company Core Datasheet (CCDS)
with respect to section 4.4 “Speciai warnings and precautions for use” and section 4.8 “Undesirabie
effects”, each under the subsection of “Transmission”. Additionaiiy, in section 4.8 “Undesirable
effects”, under the subsection of “Post-Marketing Surveiliance”, aplastic anemia has been added to
the Iist of adverse events;Updated on 22 June 2011
Reasons for updating
- Change to side-effects
Updated on 30 March 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 01 March 2011
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 15 February 2010
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 16 February 2009
Reasons for updating
- Change to warnings or special precautions for use
- Change to dosage and administration
- Change to instructions about missed dose
- Change to storage instructions
- Change to further information section
- Change to date of revision
Updated on 12 February 2009
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.7 - 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 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- 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
Change to section 2
Description of product updated
Change to section 3
Description of product updated
Change to section 4.1
Rewording of section,
Change to section 4.2
Introduction of 2 dose schedule, update to method of administration
Change to section 4.4
Reformatting of section.
Change to section 4.7
Reformatting of section
Change to section 4.8
Reformatting of section, addition of side effect observed following 2 dose regimen.
Change to section 5.1
Addition of data supporting 2 dose regimen.
Change to section 6.2
Additional statement concerning reconstitution with other medicinal products.
Change to section 6.4
Reformatting of section
Change to section 6.6
Updated on 04 August 2008
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- 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 4.2
Addition of intramuscular route of administration.
Section 4.8
Update of information, following the addition if intramuscular route of administration - safety profile is comparable between intramuscular and subcutaneous routes of administration.
Section 5.1
Addition of information - Immunogenicity profile similar for both intramuscular and subcutaneous routes of administration.
Updated on 04 August 2008
Reasons for updating
- Change to dosage and administration
Updated on 28 November 2007
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 May 2007
Reasons for updating
- Change to marketing authorisation holder address
Updated on 17 April 2007
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7 - updated the address of the Marketing Authorisation Holder.
Section 10 - changed date of revision to March 2007
Updated on 09 June 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 25 April 2006
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 July 2005
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 April 2005
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)