Metvix Cream *
Pharmacy Only: Prescription

Updated on 24 February 2022

File name

ie-ni-pil-mockup-Nov2021-P201244-1-v2-clean_1645709875.pdf

Reasons for updating

  • XPIL Updated

Updated on 05 January 2022

File name

ie-ni-pil-mockup-Nov2021-P201244-1-v2-clean_1641398754.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 06 May 2021

File name

ie-mockup-pl-approved26Apr2021-clean_1620298127.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 06 May 2021

File name

ie-spc-26Apr2021-V2-clean_1620297896.pdf

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
  • 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 01 March 2021

File name

uk-ie-pl-clean 17 Feb 21_1614598117.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

Section 3 updated to take account of use of an artificial daylight device for the treatment of AK. Section 2 updated as a consequence.

Updated on 01 March 2021

File name

Metvix IRE SPC Feb 21_1614597538.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.1 updated to include information about the treatment of AK using an artificial daylight device. Other sections updated as a consequence.

Updated on 12 June 2020

File name

Metvix 1g & 2g PIL UK & IRE V18 (P26175-7)_1591969483.pdf

Reasons for updating

  • Change to section 1 - what the product is used for

Free text change information supplied by the pharmaceutical company

Minor change to the wording for the treatment of aktinic keratosis

Updated on 12 June 2020

File name

Metvix IRE SPC V18-May20_1591969169.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Free text change information supplied by the pharmaceutical company

Minor change to the indcation for the treatment of Actinic keratosis.

Updated on 03 December 2018

File name

Metvix IRE SPC V15 DRAFT TC_1543836586.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Update to treatment of Bowens in pateints who are immunocompramised.

Updated on 07 November 2018

File name

Metvix 1g & 2g PIL UK & IRE V17 (P26175-5)_1541589135.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 12 May 2018

Reasons for updating

  • New SPC for new product

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

Updated on 17 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 17 July 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.4 - Addition of warning regarding contact with eyelids and mucous membranes
Section 10 -Updated date of text revision

Updated on 14 July 2017

File name

PIL_7863_734.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 July 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 07 April 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

In Section 4.4: Additional warning 'Metvix should not be applied to the eyelids and mucous membranes'.

Updated on 14 October 2016

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Extend shelf life after first day opening from 1 week to 28 days

Updated on 05 October 2016

Reasons for updating

  • Change to storage instructions

Updated on 25 July 2016

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

Addition of 1g pack size

Updated on 25 July 2016

Reasons for updating

  • Introduction of new pack/pack size

Updated on 13 April 2016

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 27 November 2015

Reasons for updating

  • 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 5.3 - Preclinical safety data
  • 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

Various changes including additional warning (section 4.4), use in pregnancy (section 4.6) and undesirable effect (section 4.8).

Updated on 27 November 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 17 August 2015

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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

to change the SPC and PIL due to new clinical data - day light activation

Updated on 02 July 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 02 July 2013

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability

Updated on 21 January 2013

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.3 has been updated to include hypersensitivity to peanut or soya as a contraindication.

Section 4.8 has been updated to include eyelid oedema, angioedema, face oedema, application site eczema, allergic contact dermatitis and rash pustular as potential undesirable effects with an unknown frequency of occurrence.

Updated on 02 September 2010

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Reduction in shelf-life from 18 months to 15 months.

Updated on 24 June 2009

Reasons for updating

  • Improved electronic presentation

Updated on 09 April 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 26 August 2008

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Shelf life of the product has been updated

Updated on 06 August 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Update to section 4.4 and 4.8

Updated on 27 July 2007

Reasons for updating

  • Change to marketing authorisation holder address

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

Free text change information supplied by the pharmaceutical company

Change in office address of marketing authorisation holder.

Updated on 20 April 2007

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 08 March 2007

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

Update of section 4.8 - Undesirable effects

Updated on 01 March 2007

Reasons for updating

  • Change to date of revision

Updated on 10 April 2006

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Updated on 18 May 2005

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 03 September 2004

Reasons for updating

  • Change of manufacturer
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 09 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 April 2004

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects

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

Updated on 15 August 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 16 June 2003

Reasons for updating

  • New SPC for medicines.ie

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