Last Updated on eMC 14-04-2015 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 1 - Name of the medicinal product
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:09-04-2015

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

´╗┐Section 6.1 Addition of Peppermint Flavour to title

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
  • 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:

´╗┐Sections 4.3, 4.4 & 4.8 addition of warnings in line with MHRA guidance (DSU current wording for Chlorhexidine)

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