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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: 21/02/2011
SPC Tavanic 500mg tablets

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 21/02/2011 and displayed until Current
Reasons for adding or updating:
  • 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:   02-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
New MA number
Updated on 08/01/2009 and displayed until 21/02/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   14-Sep-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.1 - the 2 indications acute bacterial sinusitis & acute bacterial exacerbations of chronic brochitis have had the following wording added;

'(adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections)'

Section 5.1 - has been re-formatted and re-worded using the EUCAST recommended MIC breakpoints and the CLSI (formerly the NCCLS) recommended breakpoints as opposed to just the NCCLS recommended MIC breakpoints. There is a new section of the PK/PD relationship and the antibactieral spectrum has been updated.

Section 6.6 - the following sentence has been added;

'As for all medicines, any unused medicinal product should be disposed of accordingly and in compliance with local environmental regulations.'
Updated on 08/07/2008 and displayed until 08/01/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   17-Sep-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Sections 4.2, 4.4, 4.5 and 4.8. Modifications relate to the undesirable effect, QT interval prolongation

Section 4.5 of the SPC with the addition of a possible interaction with some urine drug screens for opiates

Section 4.8 of the SPC with the addition of the undesirable effect “sensory or sensorimotor peripheral neuropathy
Updated on 06/03/2008 and displayed until 08/07/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update section 4.5 (Interaction with other medicinal products and other forms of interaction) of the SPC by adding the interaction of the product with the opiates. 
Update sections 4.2 (Posology and method of administration), 4.4 (Special warnings and precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction) and 4.8 (Undesirable effects) of the SPC in regard to the undesirable effect -  QT interval prolongation. 
 
Update section 4.8 (Undesirable effects) of the SPC by adding peripheral neuropathy as an undesirable
Updated on 29/11/2006 and displayed until 06/03/2008
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
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
 
Replacement of joint SPCs with individual SPCs.
Updated on 28/08/2003 and displayed until 29/11/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 26/08/2003 and displayed until 28/08/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
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