Last Updated on eMC 21-01-2015 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 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:20-01-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.5 - Change to cap material

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 4.2 - Posology and method of administration

Date of revision of text on the SPC:14-02-2012

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 amendment to typo from 'frilly' to 'fully'

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose

Date of revision of text on the SPC:14-02-2012

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Non-urgent safety updates following PSUR submission

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