Summary of Product Characteristics
last updated on the eMC:
27/09/2010
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 27/09/2010 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 4.5 - 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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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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: 01-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to section 4.2 - Posology and method of administration
Changes to section 4.3 - Contraindications
Changes to section 4.4 – Special warnings
Changes to section 4.5 – Interaction
Changes to section 4.6 – pregnancy and lactation
Changes to section 4.8 – Side effects
Changes to section 4.9 – Overdose
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Updated on 15/09/2005 and displayed until 27/09/2010
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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 11/06/2003 and displayed until 15/09/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 26/11/2002 and displayed until 11/06/2003
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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 4.9 - Overdose
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Updated on 13/08/2001 and displayed until 26/11/2002
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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