Summary of Product Characteristics
last updated on the eMC:
20/12/2011
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 20/12/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 15/07/2011 and displayed until 20/12/2011
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Reasons for adding or updating:
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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 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Updated on 07/02/2011 and displayed until 15/07/2011
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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Change of Marketing Authorisation Holder
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Product Acquisition
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Updated on 06/01/2009 and displayed until 07/02/2011
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 26/11/2003 and displayed until 06/01/2009
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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 04/09/2003 and displayed until 26/11/2003
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 10/07/2001 and displayed until 04/09/2003
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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 10/07/2001
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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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