Summary of Product Characteristics
last updated on the eMC:
25/02/2011
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 25/02/2011 and displayed until Current
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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 4.6 - Pregnancy and Lactation
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| Date of revision of text on the SPC: 01-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 and 4.6
To include warnings for pregnant and lactating mothers who could be ultra-rapid codeine metabolisers, which as a result can increase risk of opioid toxicity.
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Updated on 31/03/2010 and displayed until 25/02/2011
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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 4.4 - Special warnings and precautions for Use
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Change to Legal category
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| Date of revision of text on the SPC: 23-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to legal status of product from P to POM at request of MHRA.
Consequential changes to Section 1 (name) and 4.4 (Special warnings) - addition of codeine warnings
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Updated on 28/10/2009 and displayed until 31/03/2010
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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-May-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change in manufacturing process
Section 6.3 (Shelf Life) from 36 months to 24 months
Section 10 (Date of last revision) changed
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Updated on 18/09/2006 and displayed until 28/10/2009
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Reasons for adding or updating:
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