Summary of Product Characteristics
last updated on the eMC:
11/02/2010
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 11/02/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 23-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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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.
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Updated on 17/07/2008 and displayed until 11/02/2010
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 21-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 information relating to renal impairment - no dose change recommended
Section 4.8 very rare undesirable effects added
Section 5.2 open label data added re renal impairment and PK of pegfilgrastim
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Updated on 05/11/2007 and displayed until 17/07/2008
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 31/08/2007 and displayed until 05/11/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 28/02/2007 and displayed until 31/08/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 23/02/2007 and displayed until 28/02/2007
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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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
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Updated on 21/07/2006 and displayed until 23/02/2007
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 10/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Removal of Black Triangle
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Updated on 21/07/2006 and displayed until 21/07/2006
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 10/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Removal of Black Triangle.
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Updated on 22/11/2005 and displayed until 21/07/2006
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 12/08/2004 and displayed until 22/11/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 09/08/2004 and displayed until 12/08/2004
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 (date of (partial) revision of the text
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Updated on 05/03/2004 and displayed until 09/08/2004
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 04/03/2004 and displayed until 05/03/2004
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Pending awaiting re-submission
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Updated on 31/03/2003 and displayed until 04/03/2004
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Reasons for adding or updating:
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