Last Updated on eMC 07-12-2016 View medicine  | Norgine 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 - date of revision
  • Improved presentation of PIL
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Reasons for adding or updating:

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change of inactive ingredient
  • Change to appearance of the medicine
  • Change to packaging
  • Change to date of revision

Reasons for adding or updating:

  • New PIL for eMC ie a PIL for an existing product but one that is new to the eMC