Summary of Product Characteristics
last updated on the eMC:
15/11/2011
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 15/11/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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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 4.7 - 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 5.1 - Pharmacodynamic Properties
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Updated on 17/02/2011 and displayed until 15/11/2011
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Updated on 08/01/2010 and displayed until 17/02/2011
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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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Change to section 7 - Marketing Authorisation Holder
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Updated on 26/09/2006 and displayed until 08/01/2010
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 26/09/2006 and displayed until 26/09/2006
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 20/09/2006 and displayed until 26/09/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Pending awaiting re-submission
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Updated on 19/09/2006 and displayed until 20/09/2006
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 11/10/2005 and displayed until 19/09/2006
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 12/08/2005 and displayed until 11/10/2005
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/08/2001 and displayed until 12/08/2005
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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 06/09/1999 and displayed until 24/08/2001
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Reasons for adding or updating:
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