Summary of Product Characteristics
last updated on the eMC:
24/05/2011
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 24/05/2011 and displayed until Current
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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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| Date of revision of text on the SPC: 01-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SmPC: change to section 6.5 Nature and contents of container – addition of new pack sizes
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Updated on 06/04/2011 and displayed until 24/05/2011
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 01-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Extensive changes to the following sections: 1, 2, 3, 4.1, 4.8, 5.1, 6.1 and 6.4.
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Updated on 20/04/2010 and displayed until 06/04/2011
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 01-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 3: Amendment to clarify the pharmaceutical form and the description of the capsule and tablet
Section 6.1: Amendment to the list of excipients
Section 6.4: Amendment to the storage instruction
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Updated on 08/08/2007 and displayed until 20/04/2010
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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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: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.1 – List of excipients
Section 10 – Change to the date of revision of text
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Updated on 06/06/2006 and displayed until 08/08/2007
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Reasons for adding or updating:
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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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| Date of revision of text on the SPC: 01/12/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 9 - Date of Renewal of Authorisation and Change to section 10 (date of (partial) revision of the text
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Updated on 28/09/2005 and displayed until 06/06/2006
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Reasons for adding or updating:
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Addition of joint SPC covering all presentations
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