Summary of Product Characteristics
last updated on the eMC:
25/11/2011
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 25/11/2011 and displayed until Current
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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: 04-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Section added titled "Atypical fractures of the femur"
Section 4.8 - added section on post-marketing experience
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Updated on 23/09/2011 and displayed until 25/11/2011
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Reasons for adding or updating:
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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: 13-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Renewal of MA
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Updated on 29/07/2010 and displayed until 23/09/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 20-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| All changes are bring the SPC in line with the brandleader product.
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Updated on 18/06/2007 and displayed until 29/07/2010
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 18/06/2007 and displayed until 18/06/2007
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Reasons for adding or updating:
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New SPC for new product
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Pending awaiting re-submission
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