Last Updated on eMC 07-12-2016 View medicine  | Roche 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 1 - what the product is
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - overdose, missed or forgotten doses
  • 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 - contraindications
  • 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 - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 6 - date of revision
  • Removal of black triangle

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 2 - what you need to know - contraindications
  • 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 - warnings and precautions
  • 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 - warnings and precautions
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Correction of spelling/typing errors
  • Change to drug interactions

Reasons for adding or updating:

  • Change to date of revision
  • Change to drug interactions
  • Extra statutory information

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change of contra-indications
  • Change to drug interactions
  • Change to dosage and administration

Reasons for adding or updating:

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

Reasons for adding or updating:

  • Change to warnings or special precautions for use

Reasons for adding or updating:

  • Change to Further Information section

Reasons for adding or updating:

  • Change to drug interactions

Reasons for adding or updating:

  • Change to warnings or special precautions for use

Reasons for adding or updating:

  • Correction of spelling/typing errors

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

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to drug interactions

Reasons for adding or updating:

  • Change to date of revision

Reasons for adding or updating:

  • Change to side-effects
  • Change to date of revision

Reasons for adding or updating:

  • Change to warnings or special precautions for use

Reasons for adding or updating:

  • Change to Further Information section

Reasons for adding or updating:

  • Change to date of revision

Reasons for adding or updating:

  • Change to drug interactions
  • Change to date of revision

Reasons for adding or updating:

  • Change to drug interactions

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change from BAN to rINN

Reasons for adding or updating:

  • Change to drug interactions
  • Change to date of revision

Reasons for adding or updating:

  • Change of contra-indications

Reasons for adding or updating:

  • New PIL for new product