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Bristol-Myers Squibb Holdings Limited

Bristol-Myers Squibb Holdings Limited
Swords, Co.Dublin, Ireland
Fax: +44 (0)208 754 3677
Medical Information Direct Line: +1 800 749 749
Medical Information e-mail: medical.information@bms.com
Summary of Product Characteristics last updated on medicines.ie: 16/08/2010
SPC Questran 4g/sachet Powder for Oral Suspension

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 16/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



The updates are as follows:

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains 4g of colestyramine resin

Each sachet also contains 3.39g of sucrose

For full list of excipients, see section 6.1.

 

6.3 Shelf Life

3 years

 

9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION

1 April 1979 / 1 April 2009

 

10. DATE OF (PARTIAL) REVISION OF THE TEXT

April 2010

 

There are also minor administrative changes also.

Updated on 16/03/2005 and displayed until 16/08/2010
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 4.4 - Special warnings and precautions for use
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
Updated on 11/06/2003 and displayed until 16/03/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Cholestyramine

Versions

 
16/08/2010 to Current
16/03/2005 to 16/08/2010
11/06/2003 to 16/03/2005
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