Summary of Product Characteristics
last updated on the eMC:
31/03/2008
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 31/03/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Additional side effect: pulmonary haemorrhage
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Updated on 29/01/2007 and displayed until 31/03/2008
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 Interaction with drugs metabolised by CYP3A4 & CYP450 enzymes. See SPC for futher details.
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Updated on 31/08/2005 and displayed until 29/01/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 25/08/2005 and displayed until 31/08/2005
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 16/03/2004 and displayed until 25/08/2005
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Reasons for adding or updating:
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