Last Updated on eMC 04-01-2018 View medicine  | Generics UK T/A Mylan 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:08-12-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

´╗┐ 

 

In section 4.8 (undesirable effects) visual hallucinations has been added and the reporting of suspected adverse reactions has been updated to include 'or search MHRA Yellow Card in the Google Play or Apple App Store.

 

In section 10, the date of revision of text has been updated to 08/12/2017.

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:20-04-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

´╗┐Updated adverse event information

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