Summary of Product Characteristics
last updated on the eMC:
19/03/2009
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 19/03/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 16-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The change affects Section 4.5 and includes a warning regarding use in patients with renal failure due to risk of renal oxalate calculi.
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Updated on 29/01/2009 and displayed until 19/03/2009
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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: 01-Jun-2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to MAH to UCB Pharma Ltd
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Updated on 12/09/2005 and displayed until 29/01/2009
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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 (partial) revision of the text
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Updated on 12/09/2005 and displayed until 12/09/2005
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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 (partial) revision of the text
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Updated on 01/07/2005 and displayed until 12/09/2005
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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 4.5 - 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 5.1 - Pharmacodynamic Properties
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Change to section 10 (date of (partial) revision of the text
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Updated on 02/10/2003 and displayed until 01/07/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 05/10/2001 and displayed until 02/10/2003
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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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Updated on 25/08/2001 and displayed until 05/10/2001
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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