Last Updated on eMC 06-10-2017 View medicine  | Wockhardt UK 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 4 - possible side effects

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 - use in children/adolescents
  • Change to section 2 - driving and using machines
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • 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 4 - how to report a side effect

Reasons for adding or updating:

  • Improved presentation of PIL

Reasons for adding or updating:

  • Transfer to upgraded management system

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change of licence holder

Reasons for adding or updating:

  • New PIL for eMC ie a PIL for an existing product but one that is new to the eMC