Summary of Product Characteristics
last updated on the eMC:
12/04/2011
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 12/04/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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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 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 01-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update sections 4.3, 4.4, 4.5, 4.6, 4.8, 4.9 & 5.1 of the SPC:
4.3: Contraindications
4.4: Special warnings and precautions
4.5: Interactions with other medicinal products and other forms of interaction
4.6: Pregnancy and Lactation
4.8: Undesirable effects
4.9: Overdose
5.1: Pharmacodynamic properties
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Updated on 17/08/2010 and displayed until 12/04/2011
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Reasons for adding or updating:
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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-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 10 the Date of Revision of Text has been changed from July 2004 to 4th August 2009
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Updated on 01/06/2009 and displayed until 17/08/2010
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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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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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