Summary of Product Characteristics
last updated on the eMC:
09/09/2011
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 09/09/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 15-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SmPC - update to section 5.1
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Updated on 24/08/2011 and displayed until 09/09/2011
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 11-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to section 5.2
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Updated on 30/06/2011 and displayed until 24/08/2011
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Reasons for adding or updating:
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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 4.7 - 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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| Date of revision of text on the SPC: 21-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Updated sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8 & 4.9
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Updated on 04/09/2008 and displayed until 30/06/2011
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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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| Date of revision of text on the SPC: 03-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.4 – Addition of warning of potential psychiatric side-effects occurring with systemic steroids.
4.8 – Addition of psychiatric side-effects that have been reported with corticosteroids.
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Updated on 14/04/2008 and displayed until 04/09/2008
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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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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4 – Addition of warning of potential psychiatric side-effects occurring with systemic steroids.
4.8 – Addition of psychiatric side-effects that have been reported with corticosteroids.
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Updated on 10/03/2008 and displayed until 14/04/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 25/10/2006 and displayed until 10/03/2008
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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: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 - Change to MAH address
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Updated on 16/08/2005 and displayed until 25/10/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 24/08/2001 and displayed until 16/08/2005
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 20/07/2001 and displayed until 24/08/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 20/07/2001
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Reasons for adding or updating:
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