Last Updated on eMC 09-09-2016 View medicine  | Mylan Products 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 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Improved presentation of PIL

Reasons for adding or updating:

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to other sources of information section

Reasons for adding or updating:

  • Removal of one or more presentations from joint PIL

Reasons for adding or updating:

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Company name change or merger

Reasons for adding or updating:

  • Correction of spelling/typing errors
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to section 2 - interactions with other medicines, food or drink

Reasons for adding or updating:

  • Change to section 6 - what the product contains

Reasons for adding or updating:

  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Unknown

Reasons for adding or updating:

  • PIL Retired pending re-submission
  • Change to appearance of the medicine
  • Change to Further Information section
  • Change to date of revision

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change to dosage and administration

Reasons for adding or updating:

  • Company name change or merger
  • Change to name of manufacturer
  • Change to MA holder contact details

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation

Reasons for adding or updating:

  • Change due to user-testing of patient information
  • Change to date of revision

Reasons for adding or updating:

  • Transfer to upgraded management system

Reasons for adding or updating:

  • Change to appearance of the medicine

Reasons for adding or updating:

  • Change of manufacturer
  • Change to date of revision

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied