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

Summary of Product Characteristics last updated on the eMC: 29/11/2010
SPC Suprax Tablets 200 mg

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 29/11/2010 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 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-Nov-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
Updated on 31/07/2008 and displayed until 29/11/2010
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;

angioedema
Thrombocytosis,
hypereosinophilia,
neutropenia
agranulocytosis
Updated on 18/09/2007 and displayed until 31/07/2008
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 07/06/2006 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change from BAN to rINN
Date of revision of text on the SPC:   7/5/06
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
Updated on 14/06/2004 and displayed until 07/06/2006
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
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