Summary of Product Characteristics
last updated on the eMC:
25/07/2011
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 25/07/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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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: 05-Jul-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To register a new, alternative name on the licence (change to section 1 of SPC)
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Updated on 29/10/2010 and displayed until 25/07/2011
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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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: 18-Oct-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Nature of change: Update to section 5.1 of the SPC to align with the 2 other acrivastine-containing products in the Benadryl range, with regards to the onset of action, as determined by the ability to antagonise histamine induced wheals and flares in the skin, which is 15 minutes.
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Updated on 03/04/2008 and displayed until 29/10/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 03/2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to MA as a result of integration
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Updated on 21/04/2005 and displayed until 03/04/2008
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 28/09/2004 and displayed until 21/04/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 19/09/2002 and displayed until 28/09/2004
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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 24/08/2001 and displayed until 19/09/2002
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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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