Last Updated on eMC 11-08-2016 View medicine  | Thornton & Ross 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 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:03-08-2016

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2:

• Clarification of Chlorhexidine Gluconate 0.25% w/w as the active ingredient (included in the formulation as Chlorhexidine Gluconate 20% solution 1.25% v/w)

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:05-08-2014

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.3, 4.4 & 4.8 addition of warnings to these sections in line with MHRA guidance (DSU current wording for Chlorhexidine)

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC:10-09-2013

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 2 (QUALITATIVE AND QUANTITATIVE COMPOSION), reference to the BP monograph has been removed and the statement - "For excipients, see 6.1" has been updated to the correct terminology of " For the full list of excipients, see section 6.1.

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC:29-01-2013

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 & 2 Update to name

Reasons for adding or updating:

  • Change to section 6.1 - List of excipients

Date of revision of text on the SPC:29-01-2013

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.1 reference to excipient monographs removed

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC:17-10-2012

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to section 6.5 of SPC. Deletion of 25g pack size.

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:GSL

Black Triangle (CHM): NO