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Bristol-Myers Squibb Pharmaceuticals Ltd
South Country Business Park, Leopardstown, Dublin 18,
Telephone: +353 1 291 3800
Fax: +353 1 291 3899
Medical Information Direct Line: Freephone: 1 800 749 749
Medical Information e-mail: Medical.information@bms.com
Medical Information Facsimile: +44(0)20 8754 3677
Summary of Product Characteristics last updated on medicines.ie: 08/02/2010
SPC Sotacor 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 08/02/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 8 - MA number
  • 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:   01-Jan-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Removal of reference to 160mg Tablet from each of sections 1, 2, 3, 8, 9, 10 etc as marekting of the product was discontinued from 1st January 2010.
Updated on 25/08/2009 and displayed until 08/02/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Jan-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 2: Additional information was added to indicate that the product contains lactose monohydrate (in line with the Excipients guideline) and a statement that a full list of excipients can be found in section 6.1 (in line with the QRD template).

Section 10: the date of revision of text was updated to January 2009.
Updated on 31/03/2006 and displayed until 25/08/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Updated on 09/08/2004 and displayed until 31/03/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 22/07/2004 and displayed until 09/08/2004
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Updated on 23/06/2003 and displayed until 22/07/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

Active Ingredients

 
  sotalol hydrochloride