Summary of Product Characteristics
last updated on the eMC:
10/03/2008
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 10/03/2008 and displayed until Current
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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: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7: MAH contact address changed from The Magdalen centre, Oxford science park, Oxford, OX4 4GA, UK to 1 Albany Place, Hyde way, Welwyn Garden City, Hertfordshire, AL7 3BT
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Updated on 12/06/2007 and displayed until 10/03/2008
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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: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 - Marketing Authorisation Holder changed from:
Zeneus Pharma Ltd
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
to:
Cephalon Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
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Updated on 13/03/2006 and displayed until 12/06/2007
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Reasons for adding or updating:
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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 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 28/09/2005 and displayed until 13/03/2006
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Reasons for adding or updating:
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Change to section 8 - MA number
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Change to section 7 - Marketing Authorisation Holder
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Updated on 28/05/2004 and displayed until 28/09/2005
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Reasons for adding or updating:
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Company name change or merger
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Updated on 08/07/2003 and displayed until 28/05/2004
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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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Updated on 09/01/2002 and displayed until 08/07/2003
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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 9 - Date of Renewal of Authorisation
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Updated on 05/07/2001 and displayed until 09/01/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 03/04/2001 and displayed until 05/07/2001
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Updated on 17/11/2000 and displayed until 03/04/2001
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Updated on 06/09/1999 and displayed until 17/11/2000
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