Summary of Product Characteristics
last updated on the eMC:
02/06/2010
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 02/06/2010 and displayed until Current
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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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Change to section 4.8 - Undesirable Effects
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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: 01-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Addition of propofol interaction information.
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Change to section 4.8 - Undesirable Effects
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Update of ADR table- additional ADR’s in “not known” category
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Change to section 10 - Date of revision of the text
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26.05.10
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Updated on 16/07/2009 and displayed until 02/06/2010
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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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: 10-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 5.2 - Pharmacokinetic properties
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Addition of information regarding special populations.
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Change to section 10 – Date of revision of the text
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Changed to 10.07.09
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Updated on 21/04/2009 and displayed until 16/07/2009
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Reasons for adding or updating:
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 09-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 6.6 – Instructions for use, handling and disposal
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Addition of statement regarding Single Use only, and discarding any unused contents.
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Change to section 10 – Date of revision of the text
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09.04.09
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Updated on 09/02/2009 and displayed until 21/04/2009
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 29-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.4 – Special Warnings and Precautions for Use
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Replacement of term “asystole” with “cardiac arrest” throughout this section, for consistency with MedRA term levels (use of preferred terms).
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Change to section 10 – Date of revision of the text
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29.01.09
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Updated on 26/01/2009 and displayed until 09/02/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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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-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.8 – Undesirable effects
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Replacement of existing text with a single consolidated ADR table in System, Organ, Class format
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Change to section 10 – Date of revision of the text
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20.01.09
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Updated on 11/07/2008 and displayed until 26/01/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 02-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 7 – Marketing Authorisation Holder
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Change in address of MAH
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Updated on 14/05/2008 and displayed until 11/07/2008
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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: 07-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.4 – Special Warnings and Precautions for Use
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Addition of warning re loss of consciousness and mandatory statement re sodium content
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Updated on 17/05/2007 and displayed until 14/05/2008
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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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: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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6.1
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List of excipients
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Sodium hydroxide and hydrochloric acid are removed
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10.
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DATE OF REVISION OF THE TEXT
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Updated on 29/11/2004 and displayed until 17/05/2007
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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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 29/11/2004
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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 4.6 - Pregnancy and Lactation
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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 23/08/2001 and displayed until 30/09/2004
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 23/08/2001
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Reasons for adding or updating:
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