Last Updated on eMC 05-09-2017 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 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • 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
  • Improved presentation of PIL

Reasons for adding or updating:

  • Change to section 2 - interactions with other medicines, food or drink
  • 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 6 - marketing authorisation holder
  • 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 4 - possible side effects
  • Change to section 5 - how to store
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Reasons for adding or updating:

  • Change to date of revision
  • Change to, or new, use for medicine
  • Change to information about driving or using machinery

Reasons for adding or updating:

  • Change due to user-testing of patient information

Reasons for adding or updating:

  • Transfer to upgraded management system

Reasons for adding or updating:

  • Change to date of revision
  • Change from BAN to rINN
  • Change to drug interactions
  • Change to side-effects

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:

  • Update to PIL

Reasons for adding or updating:

  • No reasons supplied