Summary of Product Characteristics
last updated on the eMC:
11/07/2011
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 11/07/2011 and displayed until Current
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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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| Date of revision of text on the SPC: 01-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Text added (highlighted in red)
4.2 Posology and Method of Administration
Children and adolescents
The safety and efficacy of Nebivolol in children aged less than 18 years have not been established. Therefore, use in children and adolescents is not recommended.
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Updated on 25/02/2011 and displayed until 11/07/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 01-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 - MA holder address change from Sandoz ltd, 37 Woolmer way, bordon, Hampshire, GU35 9QE to Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR.United Kingdom.
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Updated on 21/12/2009 and displayed until 25/02/2011
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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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