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Metvix Cream

  • Name:

    Metvix Cream

  • Company:
    info
  • Active Ingredients:

    Methyl Aminolevulinate Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/06/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 12/6/2020

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Galderma International S.A.S. c/o Galderma (U.K) Ltd.

Galderma (U

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Medicine Name Metvix Cream Active Ingredients Methyl Aminolevulinate Hydrochloride
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1 - 0 of 16 items.Total: Infinity 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 12 June 2020 PIL

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 SPC

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 3 December 2018 SPC

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 7 November 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 12 May 2018 SPC

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 SPC

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 SPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 July 2017 PIL

Reasons for updating

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

Updated on 7 April 2017 SPC

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 SPC

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 5 October 2016 PIL

Reasons for updating

  • Change to storage instructions

Updated on 25 July 2016 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 25 July 2016 SPC

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 13 April 2016 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 27 November 2015 PIL

Reasons for updating

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

Updated on 27 November 2015 SPC

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 17 August 2015 SPC

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 2 July 2015 PIL

Reasons for updating

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

Updated on 2 July 2013 PIL

Reasons for updating

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

Updated on 21 January 2013 SPC

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 2 September 2010 SPC

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 9 April 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 26 August 2008 SPC

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 6 August 2008 SPC

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 SPC

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 PIL

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 8 March 2007 SPC

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 1 March 2007 PIL

Reasons for updating

  • Change to date of revision

Updated on 10 April 2006 SPC

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 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 3 September 2004 PIL

Reasons for updating

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

Updated on 9 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 April 2004 SPC

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 SPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 16 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

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