Summary of Product Characteristics
last updated on the eMC:
21/03/2005
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 21/03/2005 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 4.1 - 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 - 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 4.6 - Pregnancy and Lactation
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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 - Pharmacological Properties
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Change to section 6.1 - List of Excipients
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Change to section 6.2 - Incompatibilities
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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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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 22/09/2004 and displayed until 21/03/2005
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Reasons for adding or updating:
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Addition of Legal Category
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Updated on 02/07/2004 and displayed until 22/09/2004
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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 5.3 - Preclinical Safety Data
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Updated on 10/06/2004 and displayed until 02/07/2004
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Removal of Black Triangle
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Updated on 11/03/2003 and displayed until 10/06/2004
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 28/08/2002 and displayed until 11/03/2003
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 22/08/2002 and displayed until 28/08/2002
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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 17/08/2001 and displayed until 22/08/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 22/03/2001 and displayed until 17/08/2001
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Updated on 06/02/2001 and displayed until 22/03/2001
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