Summary of Product Characteristics
last updated on the eMC:
13/04/2011
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 13/04/2011 and displayed until Current
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 13-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 7 the address of the MAH, Astellas Pharma Ltd., has been updated following a move to new premises. This entails the address changing from Lovett House, Lovett Road, Staines, TW18 3AZ, United Kingdom to 3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, United Kingdom.
In section 10 the last revision date of the text has been revised to correspond with this move to new premises as detailed in Section 7. This date is updated to 13th December 2010.
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Updated on 06/01/2006 and displayed until 13/04/2011
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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 10 (date of (partial) revision of the text
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Updated on 30/12/2003 and displayed until 06/01/2006
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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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Change to section 10 (date of (partial) revision of the text
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Updated on 25/09/2003 and displayed until 30/12/2003
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Reasons for adding or updating:
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Change to joint SPC covering all presentations
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Updated on 02/08/2002 and displayed until 25/09/2003
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 6. 4 - Special Precautions for Storage
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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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Addition of Legal Category
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Updated on 09/08/2001 and displayed until 02/08/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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