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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: 20/04/2012
SPC Varilrix

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 20/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4  warning of syncope
10   new date
Updated on 16/01/2012 and displayed until 20/04/2012
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:   11-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
5.1  Update with efficacy data obtained in clinical study (OKA-H-179)

10  Updated 11 January 2012
Updated on 20/09/2010 and displayed until 16/01/2012
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Removal of Black Triangle
Date of revision of text on the SPC:   09-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1. removal of Black Triangle
Section 10 Date change
Updated on 04/03/2009 and displayed until 20/09/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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. 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:   27-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Update to recommend two doses in children aged 1 to 12 years
Section 4.3 - Further detail supporting the contra-indication in immuno-compromised subjects
Section 4.8 - Update regarding reactogenicity after second dose
Section 5.1 - Further information regarding antibody levels following a second dose
Section 6.1 - Minor adminstrative edits
Section 6.6 - Heading change to bring in line with SPC template
Section 10 - Date of revision changed to 27 February 2009
Updated on 25/11/2008 and displayed until 04/03/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.3 - Additional sentence last paragraph: In healthy subjects the presence of a minor infection, however, is not a contraindication.

Section 4.5 - New 4th Paragraph:If a measles containing vaccine is not given at the same time as Varilrix, it is recommended that an interval of at least one month between vaccinations is respected, since it is recognised that measles vaccination may cause short-term suppression of the cell-mediated response.

Section 4.8 - The whole of this section with MedRA terminology & frequencies

Section 4.9 - The whole of this section

Section 10 - Approved 29 October 2008
Updated on 15/08/2006 and displayed until 25/11/2008
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 22/10/2004 and displayed until 15/08/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 22/09/2004 and displayed until 22/10/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 02/08/2002 and displayed until 22/09/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 31/07/2002 and displayed until 02/08/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  varicella-zoster virus