Last Updated on eMC 05-07-2017 View medicine  | Ethypharm UK 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 6.3 - Shelf life

Date of revision of text on the SPC:07-04-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Extension of the shelf-life of the finished product packed in Al/PVC blister or in HDPE bottle from 2 years to 3 years.

Addition of in-use shelf-life of 6 months for the finished product packed in HDPE bottle.

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Company name change or merger

Date of revision of text on the SPC:01-07-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 - Company name and address change from DB Ashbourne Ltd to Ethypharm UK Ltd.
Section 10 - Date of revision updated to July 2016

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