Last Updated on eMC 05-10-2016 View medicine  | Contura 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 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:31-05-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

´╗┐Section 7, New Marketing Authorisation Holder
Section 8, New Marketing Authorisation Number
Section 10, New Revision Date

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life

Date of revision of text on the SPC:31-01-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

´╗┐In section 6.3, the shelf-life the PVC/PVDC/aluminium blister has been changed from 18 months to 4 years

Reasons for adding or updating:

  • New SPC for new product

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

Legal Category:POM

Black Triangle (CHM): NO