Last Updated on eMC 06-06-2016 View medicine  | Flynn Pharma Ltd 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

Date of revision of text on the SPC:01-01-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

added-

White, round, cloverleaf-shaped tablets of 8.4 mm diameter with a notched, cross-scored line on the top side and a cross-scored line embossed with “S” on each quarter on the rear side.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.7 - Effects on ability to drive and use machines

Date of revision of text on the SPC:31-12-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

To update the name of the active substance by amending the spelling of "sulphate" to Sulfate" in line with both ICH nomenclature and that used the World Health Organisation's International Non-proprietary Name programme, naming of radicals and groups. 

To register the addition of driving warnings in line with MHRA directions. 

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): YES