Zovirax Cold Sore Cream
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 July 2023
File name
ie-spc-zovirax-cold-sore-cream-separation-clean-230630RE.pdf
Reasons for updating
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 12 July 2023
File name
ie-pil-zovirax-2g-separation-clean-230630RE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 22 March 2021
File name
ie-leaflet-zovirax cold sore cream-200929SKDJ-approved.pdf
Reasons for updating
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
Replacing text leaflet with mock up
Updated on 02 February 2021
File name
ie-pl-zovirax-cold-sore-cream-clean-jan2021.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 02 February 2021
File name
ie-spc-zovirax-cold-sore-cream-clean-approved.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Updated on 26 November 2019
File name
ie-mockup-zoviraxpil190820IR-proposed.pdf
Reasons for updating
- Change to date of revision
Updated on 21 August 2019
File name
ie-spc-proposed-clean.pdf
Reasons for updating
- File format updated to PDF
Legal category:Supply through general sale
Updated on 01 February 2019
File name
ie-mockup-pl-zoviraxcream-clean-aug2018.pdf
Reasons for updating
- Addition of manufacturer
Updated on 27 June 2018
File name
ie-spc-proposed-clean.doc.docx
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Supply through general sale
Updated on 02 November 2016
File name
PIL_9974_790.pdf
Reasons for updating
- New PIL for new product
Updated on 02 November 2016
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Updated on 10 July 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 10 July 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 7
Marketing Authorisation Holder address updated to:
12 Riverwalk,
Citywest Business Campus,
Dublin 24,
Ireland
Updated on 22 May 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 21 May 2015
Reasons for updating
- Change to side-effects
Updated on 08 July 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 12 August 2010
Reasons for updating
- Change to further information section
- Change to date of revision
- Change to improve clarity and readability
- Change of special precautions for disposal
- Change due to user-testing of patient information
Updated on 16 April 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
addition of the excipient warnings for cetostearyl alcohol and propylene glycol
Updated on 17 August 2009
Reasons for updating
- Change to date of revision
Updated on 28 November 2008
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 31 October 2008
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 30 May 2007
Reasons for updating
- Improved electronic presentation
Updated on 10 April 2007
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
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 December 2006
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Limited pharmacology studies have shown only minimal systemic absorption of aciclovir following repeated topical administration of Zovirax Cold Sore Cream
Updated on 23 May 2006
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Supply through general sale
Updated on 15 June 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 05 August 2004
Reasons for 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
Legal category:Supply through general sale
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale