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Abbott Healthcare Products Limited
2.1 Woodford Business Park, Santry, Dublin 9, Ireland
Telephone: +353 1 8468793
Fax: +353 1 8468701
Medical Information Direct Line: +44 (0)2380 467 000
Medical Information e-mail: medinfo.shl@abbott.com
Medical Information Facsimile: +44 (0)2380 467052
Summary of Product Characteristics last updated on medicines.ie: 17/02/2011
SPC Colofac 135mg 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 17/02/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11-Feb-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Due to an acquisition of Solvay by Abbott, Solvay Healthcare Limited will now be known as Abbott Healthcare Products Limited and are labelling are being brought in line to reflect this.
Updated on 23/01/2009 and displayed until 17/02/2011
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:   12/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.8 of the SPC has been updated to include "rash"
Updated on 05/12/2008 and displayed until 23/01/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 2: To include information on sugars and the standard excipient wording
Section 9: To include the new renewal date
Updated on 28/03/2006 and displayed until 05/12/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
Updated on 20/07/2005 and displayed until 28/03/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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  Mebeverine Hydochloride