Summary of Product Characteristics
last updated on the eMC:
11/02/2008
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 11/02/2008 and displayed until Current
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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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| Date of revision of text on the SPC: 08/2005 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update the SPC and product labelling with regard to addiction and overuse headache as requested in the MHRA letter dated 05/07/05.
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Updated on 29/10/2004 and displayed until 11/02/2008
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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 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Updated on 06/12/2002 and displayed until 29/10/2004
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 05/12/2002 and displayed until 06/12/2002
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Reasons for adding or updating:
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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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Updated on 11/11/2002 and displayed until 05/12/2002
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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Updated on 04/03/2002 and displayed until 11/11/2002
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Reasons for adding or updating:
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