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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: 17/11/2010
SPC Orelox Tablets 100mg

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 17/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   08-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Type IB variation to include pseudomembranous colitis to section 4.8 (Undesirable effects) of the SPC, as requested by the MHRA following a review of literature and PSURs.
Updated on 18/09/2007 and displayed until 17/11/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   12/2006
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 details
Updated on 09/08/2006 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change from BAN to rINN
Date of revision of text on the SPC:   04/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.1 methicillin now reads meticiilin
Updated on 22/11/2005 and displayed until 09/08/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 26/04/2002 and displayed until 22/11/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
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