Summary of Product Characteristics
last updated on the eMC:
21/05/2013
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 21/05/2013 and displayed until Current
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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 5.1 - Pharmacodynamic properties
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Change to section 5.2 - Pharmacokinetic properties
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| Date of revision of text on the SPC: 28-Feb-2013 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| approved the Type II C.I.4 variations to update the SPC in line with the CCDS
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Updated on 08/06/2012 and displayed until 21/05/2013
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Reasons for adding or updating:
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Extra statutory information
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| Date of revision of text on the SPC: 01-May-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Amended to align with the core safety profile
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Updated on 11/11/2009 and displayed until 08/06/2012
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Reasons for adding or updating:
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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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| Date of revision of text on the SPC: 29-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| changes to sections 8. and 10. following approval of change of ownership.
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Updated on 20/10/2008 and displayed until 11/11/2009
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Reasons for adding or updating:
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Extra statutory information
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| Date of revision of text on the SPC: 01-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SPC updated in line with QRD and the latest NSAID guidance.
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Updated on 14/01/2008 and displayed until 20/10/2008
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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 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 7: MA holder changed to
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
UK
section 8: Product Licence changed to PL 19166/0059
section 10: Changed to Oct 2007
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Updated on 03/07/2002 and displayed until 14/01/2008
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Reasons for adding or updating:
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Improved Electronic Presentation
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