Summary of Product Characteristics
last updated on the eMC:
01/07/2011
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 01/07/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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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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| Date of revision of text on the SPC: 01-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.1: Paediatric population information added
In section 4.2: Paediatric posology changed
In section 4.4: Paediatric population information added
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Updated on 17/10/2008 and displayed until 01/07/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 4.8, hypothermia has been added.
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Updated on 21/12/2006 and displayed until 17/10/2008
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Reasons for adding or updating:
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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: 08/2004 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 10 - Date of revision of text corrected to 4th August 2004.
No other changes.
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Updated on 14/09/2004 and displayed until 21/12/2006
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Reasons for adding or updating:
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