Summary of Product Characteristics
last updated on the eMC:
01/03/2007
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 01/03/2007 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 changes due to PSUR, with consequential changes to Section 4.4
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Updated on 27/05/2005 and displayed until 01/03/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 27/05/2005 and displayed until 27/05/2005
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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 4.4 - Special Warnings and Precautions for Use
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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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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 (date of (partial) revision of the text
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Updated on 30/03/2005 and displayed until 27/05/2005
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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 4.4 - Special Warnings and Precautions for Use
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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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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 (date of (partial) revision of the text
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Change from the BAN of the active substance to the rINN
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Updated on 30/03/2005 and displayed until 30/03/2005
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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 4.4 - Special Warnings and Precautions for Use
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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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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 (date of (partial) revision of the text
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Change from the BAN of the active substance to the rINN
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Updated on 30/03/2005 and displayed until 30/03/2005
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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 4.4 - Special Warnings and Precautions for Use
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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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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 (date of (partial) revision of the text
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Change from the BAN of the active substance to the rINN
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Updated on 16/07/2001 and displayed until 30/03/2005
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 17/04/2001 and displayed until 16/07/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 17/04/2001
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Reasons for adding or updating:
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