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Cephalon (UK) Limited
1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire, AL7 3BT
Telephone: +44 (0) 1707 385800
Fax: +44 (0) 1707 385801
WWW: http://www.cephalon.co.uk
Medical Information Direct Line: 0800 783 4869
Medical Information e-mail: ukmedinfo@cephalon.com
Medical Information Fax: +44 (0) 1707 385802

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 17/09/2010
SPC Trisenox 1 mg/ml concentrate for solution for infusion

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 17/09/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   12-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 5.1 of the SmPC that has been updated to remove the statement relating to the authorisation of the Marketing Authorisation under Exceptional Circumstances.


Section 6.3 - includes the extension of the shelf-life from 3 to 4 years
Updated on 18/06/2009 and displayed until 17/09/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Date of revision of the text
Updated on 08/06/2009 and displayed until 18/06/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Included the date of the revision of the text to the UK SmPC for Trisenox
Updated on 08/05/2009 and displayed until 08/06/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   21-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


·         Addition of a warning for patients with hepatic and/or renal impairment in section 4.2 (Posology and method of administration) and section 4.4 (Special warnings and precautions for use);

·         Amendment of the warning in elderly patients in section 4.4 (Special warnings and precautions for use);

  • the definition of the frequency of the related grade 3 and 4 adverse drug reactions has been added to section 4.8 (Undesirable effects);
  • the criteria of listing and the frequency for the adverse events identified during the post-approval use of TRISENOX have been added to section 4.8 (Undesirable effects);
  • pancytopenia and differentiation syndrome have been added to the list of adverse events with not known frequency identified during the post-approval use of TRISENOX;
  • retinoic acid syndrome has been added in section 4.8 (Undesirable effects) as post-marketing experience reported for the treatment of malignancies other than APL with TRISENOX.
  • The full Section 5.2 (Pharmacokinetic properties) has been amended.
Updated on 09/09/2008 and displayed until 08/05/2009
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   25-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of Black Triangle
Updated on 29/08/2008 and displayed until 09/09/2008
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   25-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to MAH from Cephalon (UK0 Ltd to Cephalon France
Updated on 01/10/2007 and displayed until 29/08/2008
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change of Marketing Authorisation Holder
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 10
 
Change to Marketing Authorisation Holder
Updated on 20/06/2007 and displayed until 01/10/2007
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to Section 9 - Renewal of Authorisation date added
Updated on 27/04/2006 and displayed until 20/06/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  arsenic trioxide