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sanofi-aventis
Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: IEmedinfo@sanofi-aventis.com
Summary of Product Characteristics last updated on medicines.ie: 21/09/2011
SPC Arava 100mg Film Coated Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 21/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Sep-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
 Update Section 4.2 and 5.1
Updated on 21/01/2011 and displayed until 21/09/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   30-Apr-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use.
Updated on 07/12/2009 and displayed until 21/01/2011
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Update to section 4.6 Pregnancy and Lactation
Updated on 19/05/2008 and displayed until 07/12/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update section 4.8 Undesirable Effects
Updated on 31/08/2006 and displayed until 19/05/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   01/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update section 4.5, 4.8, 5.2 - administrative
Updated on 20/03/2006 and displayed until 31/08/2006
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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 10/11/2005 and displayed until 20/03/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 01/07/2005 and displayed until 10/11/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 09/11/2004 and displayed until 01/07/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Updated on 10/08/2004 and displayed until 09/11/2004
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Updated on 19/07/2004 and displayed until 10/08/2004
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Updated on 18/06/2003 and displayed until 19/07/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Leflunomide