Summary of Product Characteristics
last updated on the eMC:
22/06/2010
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 22/06/2010 and displayed until Current
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 28-Feb-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 16/07/2008 and displayed until 22/06/2010
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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Company name change or merger
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| Date of revision of text on the SPC: 28-Feb-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Updated to reflect change of ownership from Schwarz Pharma Ltd to UCB Pharma Ltd.
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Updated on 07/09/2007 and displayed until 16/07/2008
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.3 (Shelf life) - The shelf life has been changed to 48 months
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Updated on 27/09/2006 and displayed until 07/09/2007
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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 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 07/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 (MA Holder) - New address added: SCHWARZ PHARMA Limited, 5 Hercules Way, Leavesden Park, Watford, WD25 7GS, United Kingdom.
Section 10 (Date of revision of text) - New date added: July 2006
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Updated on 02/06/2005 and displayed until 27/09/2006
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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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 4.7 - Effects on Ability to Drive and Use Machines
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Updated on 27/09/2002 and displayed until 02/06/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 29/07/2002 and displayed until 27/09/2002
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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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Correction of spelling/typing errors
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Updated on 17/12/2001 and displayed until 29/07/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 16/08/2001 and displayed until 17/12/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 13/08/2001 and displayed until 16/08/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 09/08/2001 and displayed until 13/08/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 03/08/2001 and displayed until 09/08/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Change to separate SPCs covering individual presentations
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