Summary of Product Characteristics
last updated on the eMC:
13/10/2011
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 13/10/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.1 - Therapeutic indications
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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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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| Date of revision of text on the SPC: 01-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes are widespread throughout the document.
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Updated on 05/08/2011 and displayed until 13/10/2011
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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: 01-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The following sections updated:
6.3 Shelf life
3 years.
10. Date of (partial) revision of the text
July 2011
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Updated on 07/07/2008 and displayed until 05/08/2011
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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: 16-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to the name and address of the MA Holder - section 7. The following is the updated data.
7. MARKETING AUTHORISATION HOLDER
Merck Serono Ltd
Bedfont Cross
Stanwell Road
Feltham
Middlesex
TW14 8NX
UK
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Updated on 23/08/2004 and displayed until 07/07/2008
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 20/08/2004 and displayed until 23/08/2004
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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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Updated on 29/11/2002 and displayed until 20/08/2004
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 22/11/2002 and displayed until 29/11/2002
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Reasons for adding or updating:
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