Summary of Product Characteristics
last updated on the eMC:
11/05/2012
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 11/05/2012 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 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 08-May-2012 |
| 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 (Contraindications), 4.4 (Special warnings and precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction), 4.8 (Undesirable effects) and 5.2 (Pharmacokinetic properties) of the SPC and consequentially the leaflet in line with the brand leader.
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Updated on 23/08/2011 and displayed until 11/05/2012
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Reasons for adding or updating:
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Change due to harmonisation of SPC
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| Date of revision of text on the SPC: 26-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Updated in line with innovator.
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Updated on 06/07/2010 and displayed until 23/08/2011
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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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