Last Updated on eMC 31-01-2017 View medicine  | Concordia International - formerly AMCo 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 6.6 - Special precautions for disposal and other handling
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage

Date of revision of text on the SPC:24-01-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



3 Pharmaceutical Form added solution for injection and Clear, sterile solution.
2 Qualitative and quantitative composition - deleted USP
4.3 Contraindications - updated this info.
4.6, Fertility, pregnancy and lactation added info
6.2, updated the incompatibilities
 6.4 added "Keep the ampoules in the outer carton in order to protect from light"
6.6  added "For single use only.If only part used, discard the remaining solution.No special requirements for disposal.Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-12-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 10 - Change in the revision date

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:12-08-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 3.2 of Posology and route of administration was updated.

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC:05-08-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



6.5.      Nature and Content of Container: description of ampoules

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC:08-01-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 was updated with new MA holder address:

Capital House, 85 King William Street,

London EC4N 7BL, UK.

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:30-01-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.3, 4.4, 4.5 and 4.8 of the SPC updated with new information.

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO