Last Updated on eMC 13-04-2016 View medicine  | Allergan 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 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change/addition of instructions for reconstitution and/ or administration

Reasons for adding or updating:

  • Change of licence holder
  • Change due to user-testing of patient information

Reasons for adding or updating:

  • Change to date of revision
  • Change to name of manufacturer

Reasons for adding or updating:

  • Change to warnings or special precautions for use

Reasons for adding or updating:

  • Company name change or merger

Reasons for adding or updating:

  • Update to PIL
  • PIL Retired pending re-submission