Last Updated on eMC 26-09-2017 View medicine  | Daiichi Sankyo UK 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 2 - what you need to know - warnings and precautions
  • Change to section 6 - marketing authorisation holder
  • Change to section 1 - what the product is used for
  • Change to section 3 - use in children/adolescents

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 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 2 - what you need to know - warnings and precautions

Reasons for adding or updating:

  • Change to section 4 - possible side effects

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 2 - interactions with other medicines, food or drink
  • 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 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Retired pending re-submission

Reasons for adding or updating:

  • Change to section 2 - interactions with other medicines, food or drink

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 2 - what you need to know - contraindications
  • Change to section 2 - use in children/adolescents
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store

Reasons for adding or updating:

  • Change due to harmonisation of PIL.

Reasons for adding or updating:

  • Change to warnings or special precautions for use

Reasons for adding or updating:

  • Addition of information on alternative format leaflets

Reasons for adding or updating:

  • Change of contra-indications
  • Change to information about pregnancy or lactation

Reasons for adding or updating:

  • Addition of joint PIL covering all presentations
  • 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 dosage and administration

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to how to administer the medicine

Reasons for adding or updating:

  • Company name change or merger

Reasons for adding or updating:

  • Company name change or merger

Reasons for adding or updating:

  • Change to side-effects

Reasons for adding or updating:

  • Update to PIL

Reasons for adding or updating:

  • New PIL for new product