Last Updated on eMC 07-12-2017 View medicine  | Diomed Developments Limited 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 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-01-2017

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 6.1(List of excipients), Citric Acid Anhydrous has been updated to Citric Acid.

In section 10 (Date of revision of the text), the date has changed to January 2017.  

Reasons for adding or updating:

  • 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:01-06-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.8 Undesirable effects, the following text has been added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.


In section 10 Date of revision of the text, the date has changed to "June 2015"

Reasons for adding or updating:

  • New SPC for new product

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

Legal Category:P

Black Triangle (CHM): NO