Summary of Product Characteristics
last updated on the eMC:
08/03/2011
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 08/03/2011 and displayed until Current
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Reasons for adding or updating:
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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: 03-Sep-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SPC updated to reflect the change of licence holder from Shire to Almirall.
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Updated on 13/01/2009 and displayed until 08/03/2011
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 17-Jun-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Minor chnages made during renewal
In section 4.3 Contraindications hypersensitivity to salcylates is included
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Updated on 07/05/2004 and displayed until 13/01/2009
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 18/09/2003 and displayed until 07/05/2004
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 20/07/2001 and displayed until 18/09/2003
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 18/12/2000 and displayed until 20/07/2001
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Reasons for adding or updating:
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Updated on 16/08/2000 and displayed until 18/12/2000
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 16/08/2000
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Reasons for adding or updating:
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