Last Updated on eMC 02-11-2017 View medicine  | Aspen 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
  • Change to section 6 - manufacturer

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 - date of revision
  • Improved presentation of PIL

Reasons for adding or updating:

  • Change to warnings or special precautions for use

Reasons for adding or updating:

  • Change to side-effects

Reasons for adding or updating:

  • Change to warnings or special precautions for use

Reasons for adding or updating:

  • Change due to user-testing of patient information

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change to how to administer the medicine
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to instructions about overdose

Reasons for adding or updating:

  • Update to PIL

Reasons for adding or updating:

  • Update to PIL

Reasons for adding or updating:

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