Last Updated on eMC 08-11-2017 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 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to section 4 - how to report a side effect

Reasons for adding or updating:

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 6 - date of revision
  • Change to other sources of information section

Reasons for adding or updating:

  • Change to Marketing Authorisation Holder
  • Change to Marketing Authorisation Number

Reasons for adding or updating:

  • Change due to user-testing of patient information
  • Transfer of Marketing Authorisation Holder

Reasons for adding or updating:

  • Change to date of revision
  • Change of trade or generic name
  • Change to, or new, use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects

Reasons for adding or updating:

  • Change from the BAN of the active substance to the rINN
  • Correction of spelling/typing errors
  • 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:

  • No reasons supplied