Summary of Product Characteristics
last updated on the eMC:
28/06/2010
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 28/06/2010 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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| Date of revision of text on the SPC: 02-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.4 - Additional wording regarding use in reduced respiratory reserve, eg "conditions including but not restricted to the following" and sleep apnoea added
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Updated on 20/04/2009 and displayed until 28/06/2010
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 01-Jul-2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5 - Addition of 10 ampoule pack.
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Updated on 15/09/2005 and displayed until 20/04/2009
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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 30/09/2004 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 23/08/2001 and displayed until 30/09/2004
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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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SPC Retired pending re-submission
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