Summary of Product Characteristics
last updated on the eMC:
25/01/2011
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 25/01/2011 and displayed until Current
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Reasons for adding or updating:
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 10-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update - implementation of agreed Core Safety Profile (PSUR worksharing) - Section 4 - Clinical particulars.
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Updated on 27/09/2010 and displayed until 25/01/2011
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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| Date of revision of text on the SPC: 23-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update of product names according to current guidelines.
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Updated on 07/07/2010 and displayed until 27/09/2010
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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| Date of revision of text on the SPC: 01-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.3 Additional contraidication for patients suffering from Huntington's Chorea
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Updated on 11/12/2008 and displayed until 07/07/2010
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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 to section 10 date of revision of the text
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| Date of revision of text on the SPC: 06-Dec-2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update of PL numbers PL 00039/0534, 0535, 0536.
Update of MAH address to: 208 Bath Road, Slough, Berkshire, SL1 3WE.
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Updated on 16/08/2005 and displayed until 11/12/2008
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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