Summary of Product Characteristics
last updated on the eMC:
06/10/2011
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 06/10/2011 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-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.3 Shelf life: Addition of in-use shelf-life:
Unopened container: 2 years
After first opening of container: 6 months
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Updated on 15/07/2011 and displayed until 06/10/2011
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Reasons for adding or updating:
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Improved Electronic Presentation
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| Date of revision of text on the SPC: 01-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 05/11/2010 and displayed until 15/07/2011
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.9 - Overdose
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 01-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Updates in line with the company core safety information.
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Updated on 28/10/2008 and displayed until 05/11/2010
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.2 - Incompatibilities
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instructions for use, handling and disposal
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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-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.8, undesirable effects have been updated to include frequency details.
Other sections have been updated with the aim of achieving consistency across the product range.
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Updated on 18/05/2007 and displayed until 28/10/2008
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 5.3 - Preclinical Safety Data
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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 4.4: Addition of warning re exposure to sunlight.
Section 4.5: Amendment to wording.
Section 5.3: Information from new studies added.
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Updated on 10/11/2003 and displayed until 18/05/2007
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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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Updated on 23/05/2003 and displayed until 10/11/2003
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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 (partial) revision of the text
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Updated on 01/05/2002 and displayed until 23/05/2003
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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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Updated on 03/08/2001 and displayed until 01/05/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 30/01/2001 and displayed until 03/08/2001
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Reasons for adding or updating:
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Updated on 28/01/2000 and displayed until 30/01/2001
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Updated on 06/09/1999 and displayed until 28/01/2000
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