Summary of Product Characteristics
last updated on the eMC:
08/01/2010
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 08/01/2010 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: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The SPC for Piriteze (P) has been updated to align with Article 30 harmonisation referral for Zyrtec.
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Updated on 22/06/2009 and displayed until 08/01/2010
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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: 17-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The licence now has unlimited expiry.
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Updated on 15/05/2008 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: 04-Apr-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 6.5 (nature and contents of container), the 7 pack size has been removed
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Updated on 22/10/2007 and displayed until 15/05/2008
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 10/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 Addition of "in adults and children aged 6 years and over"
Section 4.2 Dosing changed from adults and children over 12 to adults and children aged 6 years and over. Addition of statement "Not for use by children under 6 years of age"
Section 10 Updated
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Updated on 19/06/2007 and displayed until 22/10/2007
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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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