Summary of Product Characteristics
last updated on the eMC:
26/01/2012
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 26/01/2012 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 4.9 - Overdose
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 25-Jan-2012 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update Sections 4.2, 4.3, 4.4, 4.8 and 4.9 in line with recommendations in the PSUR and current information provided in BNF and Martindale. Consequential updates are made to the PIL and label.
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Updated on 22/11/2011 and displayed until 26/01/2012
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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: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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