Summary of Product Characteristics
last updated on the eMC:
21/09/2009
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 21/09/2009 and displayed until Current
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Reasons for adding or updating:
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Change to joint SPC covering all presentations
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| Date of revision of text on the SPC: 01-Jun-2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The SPCs have been combined for both strengths.
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Updated on 26/05/2009 and displayed until 21/09/2009
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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: 01-Jun-2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 - MA Holder address updated
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Updated on 28/09/2004 and displayed until 26/05/2009
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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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Updated on 01/04/2003 and displayed until 28/09/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 20/02/2003 and displayed until 01/04/2003
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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 4.3 - 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 4.6 - Pregnancy and Lactation
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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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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 24/07/2002 and displayed until 20/02/2003
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 (date of (partial) revision of the text
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