Last Updated on eMC 12-07-2018 View medicine  | Pfizer Consumer Healthcare 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 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:06-06-2018

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



In section 4.4  & 4.8 - Added new severe skin reactions  e.g. severe skin reactions, including acute generalized exanthematous pustulosis (AGEP)

 

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:P

Black Triangle (CHM): NO