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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

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?
Summary of Product Characteristics last updated on the eMC: 16/08/2010
SPC Suprax Powder for Paediatric Oral Suspension

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 16/08/2010 and displayed until Current
Reasons for adding or updating:
  • 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:   17-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 7: Marketing Authorisation Holder  changed as follows:-

            Aventis Pharma LimitedMay & Baker Limited

trading as Rhône-Poulenc Rorer or Aventis Pharma

50 Kings Hill Avenue

Kings Hill

West Malling

Kent 

ME19 4AH

UK

 

or trading as

 

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Section 8: Marketing Authorisation Numbers changed as follows:-

 

            PL 04425/062200012/0318
Updated on 31/07/2008 and displayed until 16/08/2010
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-Jul-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;

Rare cases of angioedema
Thrombocytosis
Neutropenia
Agranulocytosis
Hypereosinophilia
Updated on 14/03/2008 and displayed until 31/07/2008
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
A variation was submitted to change the flavouring used in the product, at this time a change to the excipients section of the SPC was anticipated and a fragment was submitted with the variation. However the MHRA approved the variation but said that the details on the SPC did not need to change. This lead to a new date of revision of the SPC without any changes to the text within the SPC.
Updated on 18/09/2007 and displayed until 14/03/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   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
Updated on 14/06/2004 and displayed until 18/09/2007
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
  cefixime