Summary of Product Characteristics
last updated on the eMC:
03/02/2012
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 03/02/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.1 - Therapeutic 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 - 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 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 24-Jan-2012 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Nature of change: Changes to SPC resulting from MRP procedure: changes to sections 1, 2, 3, 4.1, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 6.1, 6.4 and 6.6
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Updated on 12/10/2010 and displayed until 03/02/2012
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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