Summary of Product Characteristics
last updated on the eMC:
10/06/2011
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 10/06/2011 and displayed until Current
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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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: 25-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Sections 4.3, 4.4, 4.5, 4.7, 4.8, 4.9 and 10 updated as a result of the update of the Company Core Safety Information.
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Updated on 19/09/2008 and displayed until 10/06/2011
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Reasons for adding or updating:
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Change to MA holder contact details
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| Date of revision of text on the SPC: 31-Jul-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to MA Holder
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Updated on 27/11/2007 and displayed until 19/09/2008
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change of Marketing Authorisation Holder
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| Date of revision of text on the SPC: 07/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7: Change to Marketing Authorisation Holder
Section 8: Change to Marketing Authorisation Number
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Updated on 07/01/2005 and displayed until 27/11/2007
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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 06/01/2005 and displayed until 07/01/2005
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 02/08/2001 and displayed until 06/01/2005
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Reasons for adding or updating:
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Transferred from eMC version 1
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Pending awaiting re-submission
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Updated on 06/09/1999 and displayed until 02/08/2001
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Reasons for adding or updating:
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