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Cervagem

Last Updated on eMC 17-Jan-2014 View document  | 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.

Updated on 17-Jan-2014 and displayed until Current

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-Jan-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

Updated on 20-Jun-2012 and displayed until 17-Jan-2014

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product

Date of revision of text on the SPC: 09-Feb-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'

Updated on 20-Feb-2012 and displayed until 20-Jun-2012

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-Feb-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.

Updated on 17-Sep-2007 and displayed until 20-Feb-2012

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

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

Updated on 17-Aug-2006 and displayed until 17-Sep-2007

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-Sep-2005

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to date in section 10

Updated on 14-Mar-2006 and displayed until 17-Aug-2006

Reasons for adding or updating:

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

Updated on 14-Jan-2002 and displayed until 14-Mar-2006

Reasons for adding or updating:

  • Change to section 4.3 - Contra-indications

Updated on 16-Jul-2001 and displayed until 14-Jan-2002

Reasons for adding or updating:

  • Transferred from eMC version 1

Updated on 08-Dec-2000 and displayed until 16-Jul-2001

Reasons for adding or updating:

  • No reasons supplied

Company contact details

SANOFI

Company image
Address

1 Onslow Street, Guildford, Surrey, GU1 4YS, UK

Fax

+44 (0)1483 535 432

Medical Information e-mail
Telephone

+44 (0)1483 505 515

Medical Information Direct Line

+44 (0)845 372 7101

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

gemeprost

Legal categories

POM - Prescription Only Medicine

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