Last Updated on eMC 08-04-2016 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 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

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 - contraindications
  • 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 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • 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 - date of revision

Reasons for adding or updating:

  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change of contra-indications

Reasons for adding or updating:

  • Change to date of revision
  • Change to MA holder contact details

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:

  • Change to date of revision
  • Correction of spelling/typing errors
  • Change of licence holder

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Transfer to upgraded management system

Reasons for adding or updating:

  • Change due to harmonisation of patient information leaflet

Reasons for adding or updating:

  • Change to warnings or special precautions for use

Reasons for adding or updating:

  • New PIL for new product