Last Updated on eMC 17-07-2017 View medicine  | 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.

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:27-03-2017

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

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life

Date of revision of text on the SPC:31-07-2016

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.

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC:04-05-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of a 1g pack size.

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:13-10-2015

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).

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:29-05-2015

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

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:01-12-2012

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.  

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC:01-07-2010

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.

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC:24-07-2008

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.

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:16-01-2008

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.

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC:01-02-2007

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
 

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:01-07-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update section 4.8 - undesirable effects

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications

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

Reasons for adding or updating:

  • New SPC for new product