Summary of Product Characteristics
last updated on the eMC:
23/04/2009
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 23/04/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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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-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to drug interactions and foetal effects.
Requested safety update relating to anti-epileptics and suicidal thoughts.
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Updated on 11/09/2006 and displayed until 23/04/2009
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 07/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.1: Change in excipient description from Calcium carboxymethylcellulose U.S.N.F. to Carmellose calcium Ph. Eur
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Updated on 04/05/2006 and displayed until 11/09/2006
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 04/05/06 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 (Undesirable effects) 'Elevations in hepatic enzymes, including gamma-glutamyl transferase (gamma GT) and alkaline phosphatase' has been added to the table of undesirable effects.
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Updated on 22/09/2005 and displayed until 04/05/2006
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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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