Metvix Cream
- Name:
Metvix Cream
- Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.
- Active Ingredients:
- 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

XPIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER
1. What Metvix is and what it is used for
1. What Metvix is and what it is used for
2. What you need to know before you use Metvix
2. What you need to know before you use Metvix
3. How to use Metvix
3. How to use Metvix
4. Possible side effects
4. Possible side effects
5. How to store Metvix
5. How to store Metvix
6. Contents of the pack and other information
6. Contents of the pack and other information
Click on this link to Download PDF directly
Galderma International S.A.S. c/o Galderma (U.K) Ltd.
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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 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
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
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
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
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
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 4.8 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
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
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
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
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)