Summary of Product Characteristics
last updated on the eMC:
10/12/2008
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 10/12/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 01-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to section 6.3, shelf life of the finished product (increase to 3 years)
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Updated on 30/07/2007 and displayed until 10/12/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7.1 Change to the MAH address
Section 10 Change in the date of revision
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Updated on 21/09/2005 and displayed until 30/07/2007
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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 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 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 17/12/2003 and displayed until 21/09/2005
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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 10 (date of (partial) revision of the text
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Updated on 30/09/2003 and displayed until 17/12/2003
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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 10 (date of (partial) revision of the text
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Updated on 15/08/2001 and displayed until 30/09/2003
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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 15/08/2001 and displayed until 15/08/2001
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MA number
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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 25/07/2001 and displayed until 15/08/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 11/05/2000 and displayed until 25/07/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 11/05/2000
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Reasons for adding or updating:
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