Summary of Product Characteristics
last updated on the eMC:
23/03/2011
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 23/03/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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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 4.7 - Effects on Ability to Drive and Use Machines
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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 6. 6 - Instructions for use, handling and disposal
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Change to section 10 date of revision of the text
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Updated on 06/08/2010 and displayed until 23/03/2011
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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Updated on 14/03/2002 and displayed until 06/08/2010
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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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Updated on 13/07/2001 and displayed until 14/03/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 22/06/2001 and displayed until 13/07/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 22/06/2001
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Reasons for adding or updating:
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