Last Updated on eMC 20-06-2018 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 6.5 - Nature and contents of container
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:01-06-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The SPC has been updated as follows: section 4.8 to update ADR reporting details ; section 6.5 – to remove reference to the HDPE tablet container and to add new PVDC blister as manufactured by Ascoli.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC:01-11-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The SPC has been updated as follows: Section 4.4 of SmPC to align the Voriconazole SmPC with the SmPC of the branded product, Vfend. The information on dermatological adverse events was re-positioned to give it more prominence in Section 4.4 (Warnings and Precautions) of the SmPC.

Reasons for adding or updating:

  • New SPC for new product

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

Legal Category:POM

Black Triangle (CHM): NO