Summary of Product Characteristics
last updated on the eMC:
21/01/2010
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 21/01/2010 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 10 date of revision of the text
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| Date of revision of text on the SPC: 25-Sep-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 7: MA Holder
From
E Merck Ltd
To
Merck Serono Ltd
Change to section 8: MA Number
From
PL 0493/0141
To
PL 11648/0083
Change to Section 10: Date of revision of text to reflect date of approval of change of ownership application.
From
22 October 2008
To
25 September 2009
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Updated on 18/03/2009 and displayed until 21/01/2010
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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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| Date of revision of text on the SPC: 22-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to date of renewal.
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Updated on 22/10/2008 and displayed until 18/03/2009
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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: 22-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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changed section 7 - the address of the MA Holder to:
7 Marketing Authorisation Holder
E. Merck Ltd.
Bedfont Cross, Stanwell Road
Feltham, Middlesex
TW14 8NX, UK
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Updated on 29/06/2001 and displayed until 22/10/2008
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Updated on 24/05/2000 and displayed until 29/06/2001
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Updated on 06/09/1999 and displayed until 24/05/2000
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