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Amgen Ltd
240 Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0WD , UK
Telephone: +44 (0)1223 420 305
Fax: +44 (0)1223 426 314
Medical Information Direct Line: +44 (0)1223 436 441/Freephone: 1800 523137
Medical Information e-mail: gbinfoline@amgen.com
Customer Care direct line: +44 (0)1223 436 700/Freephone: 1800 523137
Summary of Product Characteristics last updated on medicines.ie: 10/11/2011
SPC Neulasta

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 10/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   24-Oct-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
In section 6.3, the shelf-life has been changed from 30 months to 3 years.
In section 10, the date of revision has changed
Updated on 10/06/2011 and displayed until 10/11/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   27-May-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Section 4.4 (special warnings and precautions for use)

Updated to align with the changes made to section 4.8 of the SPC and addition of text regarding serious allergic reactions and WBC count

 

Section 4.8 (undesirable effects)
Updated to align with the SPC guideline and addition of the term “hypersensitivity” along with the frequency for anaphylactic reactions/ hypersensitivity reactions.

Section 10 (date of revision of the text)
Changed to 27 May 2011

Updated on 10/02/2010 and displayed until 10/06/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

New clinical data from a study in paediatric patients has led to the revision of the sections on Undesirable effects (section 4.8), pharmacodynamics (section 5.1) and pharmacokinetis (section 5.2).
Section 6.5 updated to include new presentation with automatic needle guard.
Updated on 14/07/2008 and displayed until 10/02/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.2 - addition of renal impairment
Section 4.8 - addition of very rare undesirable effects
Section 5.2 - addition of data from open label study re; renal impairment
Updated on 01/11/2007 and displayed until 14/07/2008
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 24/08/2007 and displayed until 01/11/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/08/2007 and displayed until 24/08/2007
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 28/02/2007 and displayed until 24/08/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 23/02/2007 and displayed until 28/02/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.4 - Special warnings and precautions for use

Addition of text re sickle cell crises.

Addition of text re the needle cover containing dry natural rubber which may cause allergic reactions.

Addition of text re bone imaging findings.

Section 4.8 Undesirable effects

Addition of text re rare events of cutaneous vasculitis and isolated cases of sickle cell crises.

Section 6.5 Nature and contents of container

Addition of needle cover containing dry natural rubber
Updated on 23/11/2005 and displayed until 23/02/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Updated on 10/08/2004 and displayed until 23/11/2005
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 09/08/2004 and displayed until 10/08/2004
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Updated on 05/03/2004 and displayed until 09/08/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Updated on 20/05/2003 and displayed until 05/03/2004
Reasons for adding or updating:
  • New SPC for new product

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