Last Updated on eMC 17-01-2014 View medicine  | SANOFI 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 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:09-01-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8 updated to include the new PV Legislation wording on adverse effect reporting

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product

Date of revision of text on the SPC:09-02-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

This SPC has been reloaded under 'Cervagem' rather than 'Gemeprost'

Reasons for adding or updating:

  • Change to section 10 date of revision of the text
  • Change to section 1 -Name of the Medicinal product

Date of revision of text on the SPC:09-02-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 updated with the addition of an alternative name of the medicinal product 'Cervagem 1mg Pessary'.  The existing product name has been aligned with the QRD template.

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC:01-10-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 (Marketing Authorisation Holder): change to MA Holder's address

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC:01-09-2005

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to date in section 10

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number

Reasons for adding or updating:

  • Change to section 4.3 - Contra-indications

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied