Last Updated on eMC 20-01-2015 View medicine  | Concordia International - formerly AMCo 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:15-01-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8: Addition of information on how to report a side effect

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:24-04-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 : Name of the Medicinal Product
Change of name from Acetazolamide 250mg tablets to “Acetazolamide Mercury 250mg Tablets”

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:27-03-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change of Address of Marketing Authorisation Holder to:

Mercury Pharmaceuticals Ltd

Capital House,

85 King William Street,

London EC4N 7BL, UK

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC:03-09-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 of Marketing Authorisation Holder was changed from Goldshield Pharmaceuticals Ltd to Mercury Pharmaceuticals Ltd

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