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Sandoz Limited

200 Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
Telephone: +44 (0) 1276 698020
Fax: +44 (0) 1276 698324
WWW: http://www.sandoz.com
Medical Information e-mail: sandoz@professionalinformation.co.uk
Medical Information Fax: +44 (0) 1276 698468

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: 18/04/2011
SPC Binocrit Solution for Injection in a pre-filled syringe

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 18/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


In Section 6.5:
Statement added: Pre-filled syringes (glass type I), with or without a needle safety guard, with plunger stopper (Teflon-faced rubber) sealed in a blister.
Updated on 30/09/2010 and displayed until 18/04/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
In section 4.1, mmol/l units added
In section 4.2, mmol/l units added
In section 4.4, mmol/l units added and the following statement inserted 'In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the administered ESA should be clearly recorded (or stated) in the patient file.
In section 4.8, mmol/l units added
In section 5.1, mmol/l units added
In section 10, date of revision updated
Updated on 31/03/2010 and displayed until 30/09/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   20-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
In section 4.4 an additional paragraph relating to anaemia and hepatitis C has been added.
In section 5.3 an additional paragraph has been added to the end of this section.
Updated on 25/09/2009 and displayed until 31/03/2010
Reasons for adding or updating:
  • Addition of Black Triangle
Date of revision of text on the SPC:   21-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Addition of Black Triangle
Updated on 16/04/2009 and displayed until 25/09/2009
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):   NO

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

Active Ingredients/Generics

 
  epoetin alfa