Updated on 14/04/2011 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 19/04/2010 and displayed until 14/04/2011
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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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: 08-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.1 - List of Excipients:
"Starch" has changed to "Maize Starch"
Details of the printing ink have been added:
Printing ink: Opacode Red S-1-25082
Shellac
Iron oxide, red (E172)
n-Butyl alcohol NF
Propylene glycol (E1520)
Purified water
Ammonia solution
Industrial methylated spirit
Isopropyl alcohol
Printing Ink: TekPrint SW-1102 Red Ink
Shellac
Dehydrated alcohol
Isopropyl alcohol
Butyl alcohol
Propylene glycol
Strong ammonia solution
Iron oxide, red (E172)
Potassium hydroxide
Purified water
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Updated on 28/06/2006 and displayed until 19/04/2010
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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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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4 Excipient warning regarding lactose added.
4.5 Change from the BAN to INN name for cyclosporine.
6.4 Change to the storage conditions wording.
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Updated on 09/01/2006 and displayed until 28/06/2006
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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 06/01/2006 and displayed until 09/01/2006
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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 22/07/2004 and displayed until 06/01/2006
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Change to section 10 (date of (partial) revision of the text
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Change to section 6.1 - List of Excipients
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Updated on 30/12/2003 and displayed until 22/07/2004
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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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Change to joint SPC covering all presentations
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Updated on 24/09/2002 and displayed until 25/09/2003
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Correction of spelling/typing errors
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Updated on 06/08/2002 and displayed until 24/09/2002
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Addition of Legal Category
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Updated on 07/08/2001 and displayed until 06/08/2002
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Correction of spelling/typing errors
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Updated on 13/02/2001 and displayed until 07/08/2001
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Updated on 25/02/2000 and displayed until 13/02/2001
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Updated on 06/09/1999 and displayed until 25/02/2000
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