Last Updated on eMC 28-10-2014 View medicine  | Concordia International - formerly AMCo 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 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:20-10-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

´╗┐Section 7: Marketing Authorisation Holder
Change of address.

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:14-05-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

´╗┐Section 1:- Name of the medicinal product
Section 4.4:-Special warnings and precautions for use
Section 6.5:-Nature and contents of container
Section 7:-Marketing authorisation holder
Section 10:-Date of revision of the text

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:POM

Black Triangle (CHM): NO