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Cephalon Pharma (Ireland) Ltd
Suite 43, Northwood Court, Northwood Business Campus, Santry, Dublin 9,
Telephone: +353 1 8621600
Fax: +353 1 8621601
Medical Information e-mail: UKMedInfo@cephalon.com
Summary of Product Characteristics last updated on medicines.ie: 09/01/2012
SPC Trisenox 1mg/ml concentrate for solution for infusion

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 09/01/2012 and displayed until Current
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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   22-Nov-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company


The changes are the update of the Trisenox Product Information in relation to the QRD template (version 7.0) and to the current EU SmPC guideline. A re-analysis of the clinical trials data was done to specify the frequency of the Adverse events in section 4.8 of the SmPC
Updated on 30/09/2010 and displayed until 09/01/2012
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   12-Aug-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Section 5.1 of the SmPC that has been updated to remove the statement relating to the authorisation of the Marketing Authorisation under Exceptional Circumstances.
Updated on 17/08/2010 and displayed until 30/09/2010
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   11-May-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Change to section 6.3 - extension of shelf life from 3 years to 4 years for the finished product
Updated on 15/06/2009 and displayed until 17/08/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   21-Apr-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Sections 4.2 posology; hepatic and renal impairment information added
Section 4.4 special warnings (patients with renal impairment and patients with hepatic impairment information added),
Section 4.8 undesirable effects (differentiation syndrome & pancytopenia added as unknown)
Section 5.2 PK (Pharmacokinetic data updated for distribution, metabolism, elimination, renal impairment & hepatic impairment)
Updated on 16/12/2008 and displayed until 15/06/2009
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   12/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change of MA Holder contact details from Guildford, Uk to Cephalon France
Updated on 20/08/2007 and displayed until 16/12/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 03/05/2006 and displayed until 20/08/2007
Reasons for adding or updating:
  • New SPC for medicines.ie

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