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: 10/2007 |
| 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 13/06/2007 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: 12/2006 |
| 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 Limited
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 12/06/2007 and displayed until 13/06/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 12/2006 |
| 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 Limited
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 28/09/2005 and displayed until 12/06/2007
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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 15/09/2005 and displayed until 28/09/2005
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 10 (date of (partial) revision of the text
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Updated on 28/05/2004 and displayed until 15/09/2005
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Reasons for adding or updating:
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Company name change or merger
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Updated on 24/07/2001 and displayed until 28/05/2004
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 18/01/2000 and displayed until 24/07/2001
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Reasons for adding or updating:
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