Summary of Product Characteristics
last updated on the eMC:
05/01/2009
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 05/01/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 01-Jul-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.1
Information has not changed. Typographical errors have been amended
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Updated on 03/08/2007 and displayed until 05/01/2009
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Addition to special warnings:
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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Updated on 19/09/2006 and displayed until 03/08/2007
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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: 04/2006 |
| 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 to MA Holder's address
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Updated on 15/05/2006 and displayed until 19/09/2006
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Reasons for adding or updating:
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| Date of revision of text on the SPC: 25/4/06 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 - BANs to INNs (phenobarbital, ciclosporin)
Section 4.8 - BANs to INNs (levothyroxine)
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Updated on 17/09/2004 and displayed until 15/05/2006
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 10 (date of (partial) revision of the text
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Updated on 11/09/2003 and displayed until 17/09/2004
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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 4.2 - Posology and Method of Administration
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 6.1 - List of Excipients
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Updated on 26/09/2002 and displayed until 11/09/2003
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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 15/07/2002 and displayed until 26/09/2002
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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 4.5 - 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 4.9 - Overdose
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Correction of spelling/typing errors
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Updated on 26/08/2001 and displayed until 15/07/2002
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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