Last Updated on eMC 08-12-2014 View medicine  | Zentiva 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 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:19-11-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

´╗┐To correct the description if the tabelts in the English SPC and PIL inline with Chapter 3.2.p.1

Reasons for adding or updating:

  • Improved presentation of SPC

Date of revision of text on the SPC:26-05-2014

Legal Category:POM

Black Triangle (CHM): NO

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:POM

Black Triangle (CHM): NO