Summary of Product Characteristics
last updated on the eMC:
05/03/2012
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 05/03/2012 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 4.8 - Undesirable Effects
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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-Feb-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SPC Update to sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8 and 5.3.
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Updated on 09/08/2007 and displayed until 05/03/2012
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 – MA Holder address amended from Milton Keynes to Sandwich
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Updated on 18/03/2004 and displayed until 09/08/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MA number
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Change to section 10 (date of (partial) revision of the text
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Updated on 15/04/2003 and displayed until 18/03/2004
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 05/08/2002 and displayed until 15/04/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 30/07/2001 and displayed until 05/08/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 28/01/2000 and displayed until 30/07/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 28/01/2000
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Reasons for adding or updating:
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