Summary of Product Characteristics
last updated on the eMC:
29/11/2010
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 29/11/2010 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 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 26-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes made to sections 7, 8, 9 and 10 due to change of ownership from May& baker ltd PL 00012/0316 to Aventis Pharma Limited PL 04425/0623.
7: Contact details for sanofi-aventis remain the same.
8: Changed to PL 04425/0623
9: Date of first authourisation changed to: 26 November 2009
10: Date of revision of the text: 26 November 2009
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Updated on 31/07/2008 and displayed until 29/11/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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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: 04-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Addition of the following side effects to section 4.8;
angioedema
Thrombocytosis,
hypereosinophilia,
neutropenia
agranulocytosis
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Updated on 18/09/2007 and displayed until 31/07/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 (Marketing Authorisation Holder): Change in MA Holder's details
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Updated on 07/06/2006 and displayed until 18/09/2007
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Reasons for adding or updating:
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| Date of revision of text on the SPC: 7/5/06 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.1 and 5.1 change of BAN to INN: Methicillin to meticillin
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Updated on 14/06/2004 and displayed until 07/06/2006
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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