Last Updated on eMC 03-03-2016 View medicine  | Leo Laboratories 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:

  • Improved presentation of PIL

Reasons for adding or updating:

  • Change to section 6 - what the product contains
  • Change to other sources of information section

Reasons for adding or updating:

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to other sources of information section

Reasons for adding or updating:

  • Change to date of revision
  • Change to Marketing Authorisation Holder

Reasons for adding or updating:

  • Change of inactive ingredient
  • Change to date of revision
  • Change to warnings or special precautions for use

Reasons for adding or updating:

  • Change due to harmonisation of PIL.

Reasons for adding or updating:

  • Transfer to upgraded management system

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

Reasons for adding or updating:

  • Introduction of new pack
  • Change to side-effects
  • Change to date of revision

Reasons for adding or updating:

  • Change to date of revision
  • Change to side-effects

Reasons for adding or updating:

  • Change to storage instructions
  • Change to date of revision

Reasons for adding or updating:

  • Update to PIL

Reasons for adding or updating:

  • Update to PIL

Reasons for adding or updating:

  • Update to PIL

Reasons for adding or updating:

  • New PIL for new product