Summary of Product Characteristics
last updated on the eMC:
15/07/2011
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 15/07/2011 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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| Date of revision of text on the SPC: 01-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Correction of section 4.4
Excipient warning for sodium content added.
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Updated on 27/01/2011 and displayed until 15/07/2011
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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| Date of revision of text on the SPC: 01-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1: Update of name to: Parvolex 200 mg/ml Concentrate for Solution for Infusion
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Updated on 05/05/2010 and displayed until 27/01/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 01-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 2: correction of typo - Sodium content 3.22.6 mg.
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Updated on 07/04/2010 and displayed until 05/05/2010
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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: 18-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - information on haemostatic parameters and caution in children because of risk of fluid overload.
Section 4.8 - additional side effect of prothrombin time abnormal
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Updated on 04/03/2010 and displayed until 07/04/2010
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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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: 01-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2: Addition of sodium content
Section 4.4: Sodium content warning added
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Updated on 15/09/2005 and displayed until 04/03/2010
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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 24/01/2003 and displayed until 15/09/2005
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 6.1 - List of Excipients
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Updated on 05/10/2001 and displayed until 24/01/2003
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Reasons for adding or updating:
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Updated on 25/08/2001 and displayed until 05/10/2001
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 06/09/1999 and displayed until 25/08/2001
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Reasons for adding or updating:
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