Summary of Product Characteristics
last updated on the eMC:
03/01/2012
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 03/01/2012 and displayed until Current
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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: 01-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 6.3, the shelf-life has been changed from 2 to 3 years.
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Updated on 09/09/2011 and displayed until 03/01/2012
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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: 18-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The following section updated:
9. Date of first authorization/renewal of authorization
14 December 2010
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Updated on 04/06/2008 and displayed until 09/09/2011
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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: 18-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to name and address of MA Holder - section 7. The following is the updated information:
7. Marketing authorization holder
Merck Serono Ltd
Bedfont Cross
Stanwell Road
Feltham
Middlesex
TW14 8NX
UK
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Updated on 24/06/2004 and displayed until 04/06/2008
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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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 4.8 - 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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Updated on 19/02/2002 and displayed until 24/06/2004
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 16/07/2001 and displayed until 19/02/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 01/03/2000 and displayed until 16/07/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 01/03/2000
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