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

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