Last Updated on eMC 05-10-2016 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:28-09-2016

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.5 (Nature & Contents of Container) - Deletion of 100g LDPE laminated tube

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text
  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC:04-11-2014

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.5 - Addition of new tube with MDPE liner

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:29-08-2013

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In 6.3, reference to the 100ml package and its shelf life have been removed.

In 6.5, reference to the 100ml package has been removed.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients

Date of revision of text on the SPC:20-05-2013

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updates to section 2, 4.1, 4.4, 4.8 and 6.1 at the request of the CHM regarding children with atopic eczema

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:14-02-2013

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Deletion of 120g pack size

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:GSL

Black Triangle (CHM): NO