Zovirax® 30 mg/g Eye Ointment

  • Name:

    Zovirax® 30 mg/g Eye Ointment

  • Company:
    info
  • Active Ingredients:

    Aciclovir

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/07/15

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Summary of Product Characteristics last updated on medicines.ie: 2/7/2019

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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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1 - 25 of 135 items.Total: 6 pages

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 2 July 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

File format updated from word to PDF.  Approval date of SPC 20 June 2018. 

Updated on 22 June 2018 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Improved presentation of SmPC

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

To bring the SPC description of the tube in line with the registered module 3 details and actual tube composition, by amending the wording in Section 6.5 to “White to pale yellow sterile ointment contained in a multilayer aluminium laminate tube with a tamper evident screw cap”.

This opportunity has also been taken to make a number of editorial and typographical amendments to the IE SPC, as described below:

Section 1: Removal of ® symbol from Product Name
Section 4.3: Change from ‘and’ to ‘or’ in sentence “Zovirax eye Ointment is contraindicated in patients known to be hypersensitive to aciclovir or valaciclovir, or any of the excipients as listed in section 6.1.”
Section 4.6 : Removal of sentence beginning “Experience in humans is limited…“, and re-positioning of the sentence “The use of Zovirax Eye Ointment should be considered only when the potential benefits outweigh the possibility of unknown risks.” from the beginning to the end of the Pregnancy sub-section 
Section 9: Addition of sub-headings – “Date of first authorisation:/Date of latest renewal:“, to achieve alignment with EMA QRD Template.

Updated on 21 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 21 July 2015 SmPC

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

Update to MA holder contact details - Address change

Updated on 20 July 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 10 June 2015 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changed to improve readability in line with latest Quality Review Document.

Updated on 9 June 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 11 October 2012 SmPC

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 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to:

 

Section 4.3  - Contraindications,

Section 4.4  - Special warnings and precautions for use,

Section 4.6  - Pregnancy and lactation,

Section 5.3  - Preclinical safety data

Updated on 5 October 2012 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 21 November 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 14 June 2007 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

5.3       Preclinical Safety Data

 

There is no information on the effect of aciclovir oral formulations or i.v. for infusion on human female fertility. In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.

 

NON-CLINICAL INFORMATION

     Mutagenicity

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that acyclovir does not is unlikely to pose a genetic risk to man.

 

     Carcinogenicity

Aciclovir was not found to be carcinogenic in long-term studies in the rat and the mouse.

 

     Fertility

Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at systemic doses of aciclovir greatly in excess of those employed therapeutically. Two-generation studies in mice did not reveal any effect of (orally administered) aciclovir on fertility.

 

Updated on 26 February 2007 PIL

Reasons for updating

  • Change to date of revision

Updated on 1 September 2006 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 1 June 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 December 2004 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 December 2004 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 7 January 2004 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)