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Novartis Ireland Limited
Beech House, Beech Hill Office Campus, Clonskeagh, Dublin 4,
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 27/04/2011
SPC Cataflam 50 mg 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 27/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Oct-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Changes due to approval of renewal
Updated on 20/05/2009 and displayed until 27/04/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   21-Apr-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Addition of hepatic failure and hepatic necrosis as very rare ADRs to the existing description of hepatic events in the section 4.8
Updated on 25/06/2008 and displayed until 20/05/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes to Section 3: Removal of tablet markings
Updated on 24/06/2008 and displayed until 25/06/2008
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to Section 3 - removal of tablet markings
Change to Section 6 - reduction o fshelf-life from 5 to 3 years
Updated on 14/12/2006 and displayed until 24/06/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
The changes follow a BPI update
Updated on 24/03/2006 and displayed until 14/12/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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