Last Updated on eMC 10-10-2017 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
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:18-11-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Added under Nervous system disorder 4.8

Cases of convulsions have been reported with cephalosporins including cefixime (frequency not known)

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:20-01-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 updated to include a new paragraph on Haemolytic anaemia.

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose

Date of revision of text on the SPC:23-01-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Type II No C.I.4 bulk variation to update SPC section 4.1, 4.4 and 4.8 in line with the latest Company Core Data Sheet CCDS V1.0 and V1.1 and a Type II No C.I.4 bulk variation to update SPC section 4.8 and 4.9 in line with the latest Company Core Data Sheet CCDS V1.2

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC:11-07-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Type II No C.I.4 bulk variation to update SPC section 4.5 for the above products in line with the latest Company Core Data Sheet CCDS V1.2

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications

Date of revision of text on the SPC:23-01-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Type Bulk Type IB C.1.Z variation to update section 4.3 of the SPC to comply with QRD regarding hypersensitivity to excipients.

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:26-11-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Changes made to sections 7, 8, 9 and 10 due to change of ownership from May& baker ltd PL 00012/0316 to Aventis Pharma Limited PL 04425/0623.

7: Contact details for sanofi-aventis remain the same.

8: Changed to PL 04425/0623

9: Date of first authourisation changed to: 26 November 2009

10: Date of revision of the text: 26 November 2009

Reasons for adding or updating:

  • 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:04-07-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of the following side effects to section 4.8;

angioedema
Thrombocytosis,
hypereosinophilia,
neutropenia
agranulocytosis

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC:01-11-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 (Marketing Authorisation Holder): Change in MA Holder's details

                                                                                               

Reasons for adding or updating:

  • Change from BAN to rINN

Date of revision of text on the SPC:05-07-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.1 and 5.1 change of BAN to INN: Methicillin to meticillin

Reasons for adding or updating:

  • Addition of separate SPCs covering individual presentations