Last Updated on eMC 02-12-2014 View medicine  | Thornton & Ross 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:26-11-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8 Addition of reporting of side effects

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:25-06-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 2 (qualitative and quantitative composition): Reference to BP monograph remove for actives. Addition of 'For full list of excipients, see section 6.1'.

In section 6.1 (list of excipients) : Remove reference to BP for purified water

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC:22-02-2013

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.3 & 6.5 Deletion of non-marketed pack 100ml

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