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Hospira UK Ltd
Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW
Telephone: +44 (0)1926 820 820
Fax: +44 (0) 1926 834446
WWW: http://www.hospira.com
Medical Information Direct Line: +44 (0) 1926 834400
Medical Information e-mail: medinfouk@hospira.com
Customer Care direct line: +44 (0)1926 821 022

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: 07/05/2009
SPC Vincristine Sulphate 1 mg/ml Injection (5 mg/5 ml)

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 07/05/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4..2            Posology and method of administration

            recommended children’s dosage regimen has been updated

Children: The suggested dose is 1.4 to 2 mg/m2 given on a weekly basis with a maximum weekly dose of 2 mg.  For children weighing 10 kg or less the starting dose should be 0.05 mg/kg administered as a weekly intravenous injection.

                 MARKETING AUTHORISATION HOLDER

 Address change:

Hospira UK Limited

            Queensway

            Royal Leamington Spa

            Warwickshire

            CV31 3RW

Date changes to the below:

9.         DATE OF RENEWAL OF AUTHORISATION

 

October 1995/ 2nd December 2008

 

 

        10.              DATE OF (PARTIAL) REVISION OF THE TEXT

 

2nd December 2008

 

 

 

 

 

 

 
Updated on 07/07/2004 and displayed until 07/05/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 6.2 - Incompatibilities
Updated on 26/09/2003 and displayed until 07/07/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 22/08/2001 and displayed until 26/09/2003
Reasons for adding or updating:
  • Change to section 1 - trade name

Active Ingredients/Generics

 
  vincristine sulfate