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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: +353 1 800 244 255
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 16/04/2010
SPC Zovirax Cold Sore Cream

When a pharmaceutical company changes an SPC or PIL, 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 16/04/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   15-Apr-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 4.4

addition of the excipient warnings for cetostearyl alcohol and propylene glycol
Updated on 28/11/2008 and displayed until 16/04/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   11/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 4.2:
 
Children:
Children should use the adult dose
Updated on 31/10/2008 and displayed until 28/11/2008
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 10/04/2007 and displayed until 31/10/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   11/2006
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

The change relates to section 6.1 : The addition of glycerol monostearate and macorgol stearate.
Updated on 22/12/2006 and displayed until 10/04/2007
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to Section 5.2

Limited pharmacology studies have shown only minimal systemic absorption of aciclovir following repeated topical administration of Zovirax Cold Sore Cream
Updated on 23/05/2006 and displayed until 22/12/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Updated on 05/08/2004 and displayed until 23/05/2006
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 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 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 26/06/2003 and displayed until 05/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Aciclovir