Summary of Product Characteristics
last updated on the eMC:
07/05/2010
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 07/05/2010 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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| Date of revision of text on the SPC: 06-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - now reads
Atarax® 10mg Film-coated tablets
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Updated on 06/11/2008 and displayed until 07/05/2010
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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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Change to section 4.8 - Undesirable Effects
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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: 01-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4: The following text has been added
Because of its potential anticholinergic effects, Atarax should
be used with caution in patients with bladder outflow
obstruction.
Section 4.8: The following text has been added
and urinary retention
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Updated on 22/02/2008 and displayed until 06/11/2008
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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: 02/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 6.5 -Now reads - White opaque 250/51 micron PVC/PCTFE (Aclar) - 20 micron aluminium foil blister strips containing 84 x 10mg tablets, (6 blister strips per carton)
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Updated on 08/02/2008 and displayed until 22/02/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 24/09/2007 and displayed until 08/02/2008
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 06/09/2007 and displayed until 24/09/2007
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Reasons for adding or updating:
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