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MSD Ireland (Human Health) Limited
Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 23/04/2012
SPC Arcoxia 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 23/04/2012 and displayed until Current
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:   16-Apr-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Sections 4.8 and 10 updated
Added hepatic failure (frequency: not known) to section 4.8

 
Updated on 30/03/2012 and displayed until 23/04/2012
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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   26-Mar-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Updates to Sections 4.1, 4.2, 4.8, 5.1, 10
Added indication (dental surgery pain); update side effects (alveolar osteitis).

 
Updated on 02/11/2011 and displayed until 30/03/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   26-Oct-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 4.8, fixed drug eruption has been added.
Updated on 20/09/2011 and displayed until 02/11/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   02-Sep-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Updated section 2 (lactose composition).
Updated on 28/02/2011 and displayed until 20/09/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Feb-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Update section 4.8 (side effects).

 
Updated on 09/12/2009 and displayed until 28/02/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   30-Nov-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Update to Section 4.8 following PSUR - additional side effects

 

 

 
Updated on 02/09/2009 and displayed until 09/12/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Apr-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Correction to typo in section 6.1
Updated on 17/04/2009 and displayed until 02/09/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   04/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The changes are to sections 7 and 8, due to PA transfer.
Updated on 12/01/2009 and displayed until 17/04/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 05/12/2008 and displayed until 12/01/2009
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Etoricoxib