Summary of Product Characteristics
last updated on the eMC:
16/12/2011
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 16/12/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Improved Electronic Presentation
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| Date of revision of text on the SPC: 22-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.8 (undesirable effects), Hypoxia added
The main changes are related to an update to QRD template version 7.3.1
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Updated on 10/05/2010 and displayed until 16/12/2011
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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 4.8 - 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: 28-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to the following sections:
Section 4.2 Posology and method of administration - Insertion of text for paediatric population.
Section 4.8 Undesirable effects - Inclusion of 'erythema'
Section 10. DATE OF REVISION OF THE TEXT - Change of date of revision of text.
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Updated on 31/07/2009 and displayed until 10/05/2010
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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: 02-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of 'extravasation, cyanosis and tachypnoea' to section 4. 8
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Updated on 01/04/2009 and displayed until 31/07/2009
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 01-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Product no longer has a black traingle status
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Updated on 16/06/2008 and displayed until 01/04/2009
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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 2 - Qualitative and quantitative composition
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 20-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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In section 2 (Qualitative and quantitative composition) “Excipients: Each vial of 5 ml contains 1.29 mmol sodium” has been added.
In section 4.4, (Special warnings and precautions for use) the following text has been added:
"This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6). To be taken into consideration by patients on a controlled sodium diet."
In section 5.1 under Pharmacotherapeutic group: the text ‘Alimentary track and metabolism products’ has been deleted and replaced by ‘Enzymes’
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Updated on 25/02/2008 and displayed until 16/06/2008
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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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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 12/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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A summary of results of the ALID01703 Dose optimization study in section 5.1 and 4.8 and added an additional warning in section 4.4 as per company core safety information.
" Patients with an acute underlying illness at the time of Aldurazyme infusion appear to be at greater risk for IARs. Careful consideration should be given to the patient’s clinical status prior to administration of Aldurazyme."
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Updated on 21/11/2007 and displayed until 25/02/2008
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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 5.1 - Pharmacodynamic 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: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Major revisions to section 4.8 and 5.1 with regard to the ALID00601 final study report.
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Updated on 29/06/2007 and displayed until 21/11/2007
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Updated inline with QRD template version 7.2
Section 5.1 - statement added
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Updated on 05/12/2006 and displayed until 29/06/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 30/11/2006 and displayed until 05/12/2006
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Reasons for adding or updating:
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Addition of Black Triangle
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| Date of revision of text on the SPC: 05/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 1. Name of Medicinal Product
Addition of the black triangle symbol after the product name.
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Updated on 10/07/2006 and displayed until 30/11/2006
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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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