Summary of Product Characteristics
last updated on the eMC:
19/01/2010
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 19/01/2010 and displayed until Current
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Reasons for adding or updating:
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Extra statutory information
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| Date of revision of text on the SPC: 24-Nov-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The Piriteze (GSL) SPC has been updated inorder to align with Article 30 harmonisation referral for Zyrtec.
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Updated on 22/06/2009 and displayed until 19/01/2010
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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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| Date of revision of text on the SPC: 22-Apr-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 6.5, a new pack size 12 has been added.
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Updated on 21/10/2008 and displayed until 22/06/2009
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 23-Jul-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5 - addition of a pack size of 12
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Updated on 03/07/2008 and displayed until 21/10/2008
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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 6. 5 - Nature and Contents of Container
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Change to section 10 date of revision of the text
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Change to section 4.1 - Therapeutic indications
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| Date of revision of text on the SPC: 08-Aug-2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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To amend sections 4.1 and 4.2 to include children aged 6 years and over.
Addition of pack size 14 to section 6.5
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Updated on 24/07/2007 and displayed until 03/07/2008
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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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| Date of revision of text on the SPC: 06/2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 - updated to include a specific lactose excipient warning
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Updated on 19/06/2007 and displayed until 24/07/2007
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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