Summary of Product Characteristics
last updated on the eMC:
02/01/2009
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 02/01/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 06-Feb-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Sectino 4.3, addition of 'or to any of the excipients' to number one contraindication
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Updated on 09/04/2008 and displayed until 02/01/2009
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.4 Special Warnings and precautions for use
Addition of the following text: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Change of thyroxine to levothyroxine
Section 5.1 Pharmacodynamic properties
Addition of the following text: Pharmacotherapeutic group: Antigonadotrophin, ATC code: G03XA02
Section 5.3 Preclinical safety data
Addition of the following text: There are no preclinical data of relevance which are additional to that already included in other sections of the SPC.
Additional formatting or rewording changes to sections 1; 2; 6.1; 6.2; 6.3 and 6.6 with no changes to meaning.
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Updated on 13/08/2007 and displayed until 09/04/2008
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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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| Use of sanofi aventis trading style
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Updated on 16/09/2005 and displayed until 13/08/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 01/01/0001 and displayed until 16/09/2005
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 01/01/0001
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