Last Updated on eMC 26-02-2013 View medicine  | GlaxoSmithKline Consumer Healthcare 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 1 - Name of the medicinal product
  • Change to section 6.1 - List of excipients

Date of revision of text on the SPC:15-02-2013

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 1: Removal of “Do-Do” as product name

 

Section 6.1: inclusion of components in “Colour brown” excipient

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:11-04-2008

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2: addition of “ Under 2 years : Do not use”

 

Section 4.4: addition of “ Do not take with other cough and cold medicine”

 

Section 10: date of revision changed from Feb 08 to 11 April 2008

 

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC