Last Updated on eMC 12-01-2018 View medicine  | Dr. Falk Pharma 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 4 - possible side effects
  • 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 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Reasons for adding or updating:

  • Change due to harmonisation of PIL.
  • Change to date of revision
  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to date of revision
  • Change of contra-indications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions

Reasons for adding or updating:

  • Change to date of revision
  • Change of contra-indications
  • Change to dosage and administration

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Change to dosage and administration

Reasons for adding or updating:

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

Reasons for adding or updating:

  • Improved Electronic Presentation
  • Change to dosage and administration

Reasons for adding or updating:

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