Summary of Product Characteristics
last updated on the eMC:
28/07/2011
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 28/07/2011 and displayed until Current
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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 4.6 - Pregnancy and Lactation
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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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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 11-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to Section 4.2 - Posology and method of administration
Change to Section 4.3 - Contraindications
Change to Section 4.4 - Special warnings and precautions for use
Change to Section 4.6 - Pregnancy and lactation
Change to Section 4.8 - Undesirable effects
Change to Section 4.9 - Overdose
Change to Section 5.1 - Pharmacodynamic properties
Change to Section 5.2 - Pharmacokinetic properties
Change to Section 5.3 - Preclinical data
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Updated on 03/11/2008 and displayed until 28/07/2011
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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