Last Updated on eMC 06-12-2017 View medicine  | Baxter Healthcare 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 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:30-11-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



section 2 - Update of for ingredient values/units from g/l to mg/l and Lysine Chlorhydrate to hydrochloride

section 4.8 - Addition of authority PV reporting information

section 6.1 - Removal of quantitative information

section 6.4 - Change in storage conditions from "Store below 30C, protect from light" to "Do not store above 30C.  Keep the container in the outer carton in order to protect from light"

section 10 - Approval date

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