Last Updated on eMC 21-09-2017 View medicine  | Ipsen Ltd 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 other sources of information section

Reasons for adding or updating:

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 4 - how to report a side effect
  • Addition of black triangle

Reasons for adding or updating:

  • Change/addition of instructions for reconstitution and/ or administration
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change of contra-indications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Reasons for adding or updating:

  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to side-effects

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • New PIL for new product