Summary of Product Characteristics
last updated on the eMC:
05/01/2009
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 05/01/2009 and displayed until Current
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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: 13-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to presentation not marketed which resulted in change of data of variation
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Updated on 21/02/2008 and displayed until 05/01/2009
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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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: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.1
Demineralised water
changed to
water, purified
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Updated on 20/09/2007 and displayed until 21/02/2008
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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 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 (Marketing Authorisation Holder): change to sanofi-aventis.
Section 8 (Marketing Authorisation Number): change to PL04425/0381
Section 9 (Date of First renewal/Renewal of Authorisation): 15 December 2006
Section 10 (Date of revision of text): 20 April 2007
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Updated on 26/09/2006 and displayed until 20/09/2007
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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| Date of revision of text on the SPC: 07/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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No changes to the text of the SPC has been made. Previous SPC on the eMC included all three Vallergan presentations on the one . This SPC has been entered due to the addition of separate SPCs covering individual presentations within the range of Vallergan.
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