Summary of Product Characteristics
last updated on the eMC:
30/11/2011
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 30/11/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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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 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 2 - Qualitative and quantitative composition
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Change to section 4.2 - Posology and method of administration
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 24-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to bring SPC in line with QRD SPC template
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Updated on 09/08/2010 and displayed until 30/11/2011
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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-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to sections 7 and 10 following approval of change of ownership
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Updated on 20/05/2009 and displayed until 09/08/2010
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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| Date of revision of text on the SPC: 01-Jan-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to Section 3. Pharmaceutical form: Change to marking on tablet to “V PRE'
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Updated on 20/07/2004 and displayed until 20/05/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 07/08/2001 and displayed until 20/07/2004
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Reasons for adding or updating:
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