Last Updated on eMC 08-02-2017 View medicine  | Lundbeck 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 4 - how to report a side effect

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 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to date of revision
  • Change to information about pregnancy or lactation

Reasons for adding or updating:

  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change of contra-indications
  • Change to side-effects
  • Change to drug interactions

Reasons for adding or updating:

  • Change to packaging

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Transfer to upgraded management system
  • PIL Retired pending re-submission

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to Further Information section
  • Change to date of revision
  • Changes to therapeutic indications

Reasons for adding or updating:

  • New PIL for new product