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Metvix 160 mg/g cream

Last Updated on eMC 17-Jul-2017 View document  | Galderma (U.K) Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 17-Jul-2017 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 27-Mar-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4 - addition of warning regarding contact with eyelids and mucous membranes

Section 10 - Update of date of revision of text

Updated on 14-Oct-2016 and displayed until 17-Jul-2017

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life

Date of revision of text on the SPC: 31-Jul-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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

Updated on 25-Jul-2016 and displayed until 14-Oct-2016

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC: 04-May-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of a 1g pack size.

Updated on 27-Nov-2015 and displayed until 25-Jul-2016

Reasons for adding or 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 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data

Date of revision of text on the SPC: 13-Oct-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Various minor changes and inclusion of additional warning (section 4.4), additioonal undesirable effect (seection 4.8) and use in pregnancy (Section 4.6).

Updated on 03-Aug-2015 and displayed until 27-Nov-2015

Reasons for adding or 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 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 29-May-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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

Updated on 21-Jan-2013 and displayed until 03-Aug-2015

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC: 01-Dec-2012

Legal Category:POM

Black Triangle (CHM): NO

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, angiodema, face oedema, application site eczema, allergic contact dermatitis and rash pustular as potential undesirable effects with an unknown frequency of occurrence.  

Updated on 02-Sep-2010 and displayed until 21-Jan-2013

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC: 01-Jul-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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

Updated on 25-Aug-2009 and displayed until 02-Sep-2010

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC: 24-Jul-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 6.3 the shelf life has changed from 1 year to 18 months.

Updated on 07-May-2008 and displayed until 25-Aug-2009

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 16-Jan-2008

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

In section 4.4 one of the warnings has been amended to now read as follows: Methyl aminolevulinate may cause sensitization by skin contact resulting in application site eczema or allergic contact dermatitis

In section 4.8, the following has been added: Application site eczema and allergic contact dermatitis have has been described in post-marketing reports (frequencyfrequencies not known). Most cases were localised to the treatment area and were not severe; rarely erythema and swelling have been more extensive.

Updated on 16-May-2007 and displayed until 07-May-2008

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 01-Feb-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update of section 7 - change in address of marketing authorisation holder
 

Updated on 01-Mar-2007 and displayed until 16-May-2007

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 01-Jul-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update section 4.8 - undesirable effects

Updated on 19-Apr-2006 and displayed until 01-Mar-2007

Reasons for adding or updating:

  • Correction of spelling/typing errors

Updated on 10-Apr-2006 and displayed until 19-Apr-2006

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications

Updated on 19-Apr-2004 and displayed until 10-Apr-2006

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.8 - Undesirable Effects

Updated on 27-Mar-2003 and displayed until 19-Apr-2004

Reasons for adding or updating:

  • New SPC for new product

Company contact details

Galderma (U.K) Ltd

Company image
Address

Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, UK

Fax

+44 (0)1923 208998

Telephone

+44 (0)1923 208950

Medical Information e-mail

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

methyl aminolevulinate hydrochloride

Legal categories

POM - Prescription Only Medicine

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