Last Updated on eMC 14-09-2016 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 6.5 - Nature and contents of container

Date of revision of text on the SPC:08-09-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.5 of the SPC has been updated

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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:27-02-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section:-10. Date of revision of the text
Section:-4.1 Therapeutic indications
Section:-4.2 Posology and method of administration
Section:-4.3 Contraindications
Section:-4.4 Special warnings and precautions for use
Section:-4.8 Undesirable effects

Reasons for adding or updating:

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

Date of revision of text on the SPC:30-08-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 10: Date of revision changed

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:30-08-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The following sections of the SPC has been changed:

6.5: Nature and contents of container

7: Marketing Authorisation Holder

8: MArketing Authorisation Nos

10: Change in revision of text

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product

Date of revision of text on the SPC:25-05-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0Tochange section 1 of the SPC that is the name of the medicinal product in order to comply with the new QRDTemplate.$0

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:20-10-2010

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

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

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

Legal Category:POM

Black Triangle (CHM): NO