Last Updated on eMC 22-05-2017 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 1 - what the product is
  • 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 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 4 - possible side effects
  • Change to information for healthcare professionals
  • Improved presentation of PIL

Reasons for adding or updating:

  • 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 2 - driving and using machines
  • 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 section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change of contra-indications
  • Change to storage instructions
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to Further Information section
  • Change to date of revision
  • Change to, or new, use for medicine
  • Change to warnings or special precautions for use

Reasons for adding or updating:

  • Change to date of revision

Reasons for adding or updating:

  • Change/addition of instructions for reconstitution and/ or administration
  • Change to date of revision

Reasons for adding or updating:

  • Change to Further Information section
  • Change to date of revision

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Update to PIL

Reasons for adding or updating:

  • No reasons supplied