Last Updated on eMC 11-07-2018 View medicine  | Boehringer Ingelheim 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 - date of revision
  • Change to other sources of information section
  • Change to section 4 - how to report a side effect

Reasons for adding or updating:

  • Improved presentation of PIL

Reasons for adding or updating:

  • 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
  • Change to other sources of information section

Reasons for adding or updating:

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - overdose, missed or forgotten doses
  • 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 - contraindications
  • 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 - date of revision

Reasons for adding or updating:

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

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 4 - possible side effects
  • Change to section 5 - how to store
  • Change to section 6 - date of revision
  • Change to other sources of information section

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
  • Change to other sources of information section

Reasons for adding or updating:

  • Change to Further Information section
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change of contra-indications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to dosage and administration
  • Change to MA holder contact details

Reasons for adding or updating:

  • Change to date of revision
  • Change of manufacturer

Reasons for adding or updating:

  • Change to manufacturer contact details
  • Change to MA holder contact details

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to MA holder contact details

Reasons for adding or updating:

  • Change to side-effects

Reasons for adding or updating:

  • Change to side-effects

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change of contra-indications
  • Change to information about pregnancy or lactation

Reasons for adding or updating:

  • Transfer to upgraded management system

Reasons for adding or updating:

  • Change to date of revision

Reasons for adding or updating:

  • Change to date of revision

Reasons for adding or updating:

  • Change to date of revision

Reasons for adding or updating:

  • Change to date of revision
  • Pending awaiting re-submission

Reasons for adding or updating:

  • Change to date of revision

Reasons for adding or updating:

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