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Sinclair IS Pharma

Office Village, Chester Business Park, Chester , CH4 9QZ
Telephone: +44 (0) 1244 625 150
Fax: +44 (0) 1244 625 151
WWW: http://www.ispharma.plc.uk
Medical Information Direct Line: +44 (0) 1244 625 152
Medical Information e-mail: enquiries@ispharma.plc.uk
Customer Care direct line: +44 (0) 1244 625 152
Medical Information Fax: +44 (0) 1748 828 801

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: 11/01/2011
SPC Aloxi 250 micrograms solution for injection

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 11/01/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   20-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

  • Section 4.2 (posology), wording regarding usage in children has been amended to "The safety and efficacy in children have not been established. Currently available data are described in section 5.1 and section 5.2, but no recommendation on posology can be made". 
  • Section 5.1(pharmacodynamic properties), clause relating to paediatric use has been added.
  • Section 5.2 (pharmacokinetic properties), pharmacokinetic data relating to paediatric population have been added.
Updated on 29/04/2010 and displayed until 11/01/2011
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  palonosetron hydrochloride