Summary of Product Characteristics
last updated on the eMC:
22/09/2010
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 22/09/2010 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 4.4 - 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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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6.2 - Incompatibilities
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Change to section 6. 3 - Shelf Life
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Change to section 6. 6 - Instructions for use, handling and disposal
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Removal of Black Triangle
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| Date of revision of text on the SPC: 26-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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The changes fall into 4 categories:
1) The black triangle has been removed from the SmPC as this is no longer a requirement, but it remains on the promotional material until further notice.
2) Changes to sections 5.1 & 5.2 are corrections from a previously approved variation
3) Changes to sections 4.2, 4.4, 6.2, 6.3 & 6.6 relate to a variation to include 5% glucose solution as a diluent if dilution is required
4) Changes to sections 4.4 & 4.8 relate to a variation to amend haemolysis wording
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Updated on 04/05/2010 and displayed until 22/09/2010
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Reasons for adding or updating:
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Change to section 6.2 - Incompatibilities
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Change to section 10 date of revision of the text
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Addition of link to EMEA website
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| Date of revision of text on the SPC: 20-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Change to section 6.2 to remove reference to section 6.6 and change the European Medicines Agency details.
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Updated on 12/02/2010 and displayed until 04/05/2010
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 28-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| In section 6.3, the shelf life has been changed from 2 to 3 years.
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Updated on 25/09/2009 and displayed until 12/02/2010
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Reasons for adding or updating:
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Introduction of new pack/pack size
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| Date of revision of text on the SPC: 21-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Addition of 2.5g pack size
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Updated on 12/06/2009 and displayed until 25/09/2009
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Reasons for adding or updating:
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Introduction of new pack/pack size
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| Date of revision of text on the SPC: 07-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Addition of 2.5g vial
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Updated on 04/03/2009 and displayed until 12/06/2009
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Reasons for adding or updating:
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Addition of Black Triangle
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| Date of revision of text on the SPC: 25-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Addition of black triangle
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Updated on 17/12/2008 and displayed until 04/03/2009
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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