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: GSL |
| 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 31/01/2008 and displayed until 13/04/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 01/2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4 Special warnings and special precautions for use
None known has been deleted and replaced with Cetostearyl alcohol may cause local skin reactions (e.g.contact dermatitis).
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Updated on 06/01/2006 and displayed until 31/01/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/08/2005 and displayed until 06/01/2006
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Reasons for adding or updating:
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Addition of Legal Category
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 14/01/2002 and displayed until 24/08/2005
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Change to section 6.1 - List of Excipients
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Change to section 10 (date of (partial) revision of the text
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Updated on 26/11/2001 and displayed until 14/01/2002
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Change to section 2 - qualitative and quantitative composition
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Updated on 14/08/2001 and displayed until 26/11/2001
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Correction of spelling/typing errors
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Updated on 20/10/2000 and displayed until 14/08/2001
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Updated on 26/05/2000 and displayed until 20/10/2000
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Updated on 28/01/2000 and displayed until 26/05/2000
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Updated on 06/09/1999 and displayed until 28/01/2000
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