Last Updated on eMC 03-03-2017 View medicine  | Pfizer 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 4 - how to report a side effect
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • 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

Reasons for adding or updating:

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Correction of spelling/typing errors

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 1 - what the product is used for
  • Change to section 4 - possible side effects
  • 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

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 - warnings and precautions
  • Change to section 4 - possible side effects

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 5 - how to store
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Reasons for adding or updating:

  • Change to how the medicine works
  • Change to Further Information section
  • Change to date of revision
  • Correction of spelling/typing errors
  • Change to warnings or special precautions for use
  • Change of contra-indications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions

Reasons for adding or updating:

  • Change/addition of instructions for reconstitution and/ or administration
  • Change to, or new, use for medicine
  • Change to dosage and administration

Reasons for adding or updating:

  • Change to drug interactions

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change to drug interactions

Reasons for adding or updating:

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

Reasons for adding or updating:

  • Change to date of revision
  • Change to drug interactions

Reasons for adding or updating:

  • Transfer to upgraded management system

Reasons for adding or updating:

  • Change to warnings or special precautions for use
  • Change of contra-indications
  • Change to drug interactions
  • Change to date of revision

Reasons for adding or updating:

  • Change of contra-indications
  • Change to drug interactions
  • Change to warnings or special precautions for use
  • Change to Further Information section
  • Change to date of revision
  • PIL Retired combination of strengths

Reasons for adding or updating:

  • Change to, or new, use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to Further Information section
  • Change to date of revision
  • Improved Electronic Presentation
  • Change to dosage and administration
  • Change to how to administer the medicine
  • Change of special precautions for disposal

Reasons for adding or updating:

  • Change to manufacturer contact details

Reasons for adding or updating:

  • Change to drug interactions

Reasons for adding or updating:

  • PIL Retired pending re-submission
  • Change to drug interactions

Reasons for adding or updating:

  • Change to, or new, use for medicine
  • Change of contra-indications
  • Change to side-effects
  • Change to Further Information section
  • Change to warnings or special precautions for use
  • 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