Summary of Product Characteristics
last updated on the eMC:
29/09/2008
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 29/09/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 of the SPC updated to include anaphylactic reaction as requested by the MHRA
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Updated on 13/08/2007 and displayed until 29/09/2008
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.5 –sulphinpyrazone to sulfinpyrazone
7 –Milton Keynes address to Sandwich address
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Updated on 07/09/2006 and displayed until 13/08/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 02/11/2004 and displayed until 07/09/2006
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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 4.8 - Undesirable Effects
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Updated on 05/06/2003 and displayed until 02/11/2004
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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 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 26/09/2002 and displayed until 05/06/2003
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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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Change to section 10 (date of (partial) revision of the text
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Updated on 19/02/2002 and displayed until 26/09/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 23/01/2002 and displayed until 19/02/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 07/01/2002 and displayed until 23/01/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 05/10/2001 and displayed until 07/01/2002
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 10 (date of (partial) revision of the text
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Updated on 31/07/2001 and displayed until 05/10/2001
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Reasons for adding or updating:
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Change from datasheet to SPC
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