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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: 23/01/2012
SPC Vepesid Soft Capsules 50 mg & 100 mg

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 23/01/2012 and displayed until Current
Reasons for adding or updating:
  • Addition of legal category
Date of revision of text on the SPC:   01-May-2007
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
LEGAL CATAGORY

POM added
Updated on 08/08/2007 and displayed until 23/01/2012
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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:   07/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes made at during renewal process:
 
Section 1:  'Soft' added to the Tradename
 
Section 2:  Quantitative information regarding parahydroxybenzoate added
 
Section 4.8:  Subsection on 'cardiovascular' added
 
Section 6.1:  As per guidelines
 
Section 6.6:  Moved information regarding opening blister if evidence of capsules leakage from 6.4 to this section.
 
Updated on 21/01/2005 and displayed until 08/08/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Updated on 05/11/2004 and displayed until 21/01/2005
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 13/06/2003 and displayed until 05/11/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Etoposide