Summary of Product Characteristics
last updated on the eMC:
10/02/2012
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 10/02/2012 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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 06-Feb-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.8 Pain at injection site
10 Revised date
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Updated on 16/01/2012 and displayed until 10/02/2012
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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: 22-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4 warning of syncope
10 revision date
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Updated on 03/06/2011 and displayed until 16/01/2012
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Removal of Black Triangle
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| Date of revision of text on the SPC: 01-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Removal of Black Triangle
10. Revision date change
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Updated on 16/12/2010 and displayed until 03/06/2011
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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: 15-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| 1. Black Triangle added (was missing from previous update - typo error)
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Updated on 14/12/2010 and displayed until 16/12/2010
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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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: 26-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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4.1 Replace “for use” with “indicated” and replace “persons” with “children & adolescents”
4.2 Addition of : “The safety and efficacy of Ambirix in children aged less than 1 year have not been established.” and persistence update
4.6 Addition of “Fertility”
4.7 Ambirix has no or negligible influence on the ability to drive and use machines
4.8 Update on clinical trial data and post-marketing surveillance
4.9 Update on post-marketing surveillance
5.1 Update on persistence data
6.6 Replace ”vaccine” with “product”
10. Date update
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Updated on 30/03/2009 and displayed until 14/12/2010
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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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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 05-Sep-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Deleted "Thiomersal (an organomercuric compound) has been used in the manufacturing process of this medicinal product and residues of it are present in the final product. Therefore, sensitisation reactions may occur."
Section 4.8 - Added "The current formulation of Ambirix does not contain thiomersal (an organomercuric compound) or any preservative. In a clinical study conducted with 3 doses of the current formulation in adults, the incidence of pain, redness, swelling, fatigue, gastro-enteritis, headache and fever was comparable to the incidence observed with the former thiomersal and preservative containing vaccine formulation. The following adverse reactions have been reported following the widespread use of the former formulation"
Section 5.1 - Added "These data were generated with the former Ambirix formulation containing thiomersal and a preservative. A clinical study conducted with 3 doses of the current formulation in adults showed that the current formulation elicited similar seroprotection and seroconversion rates as compared to the former formulation.
Section 6.1 - Deleted "phenoxyethanol"
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Updated on 17/02/2009 and displayed until 30/03/2009
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 05-Sep-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Reintroduced "Thiomersal (an organomercuric compound) has been used in the manufacturing process of this medicinal product and residues of it are present in the final product. Therefore, sensitisation reactions may occur."
Section 4.8 - Deleted "The current formulation of Ambirix does not contain thiomersal (an organomercuric compound) or any preservative. In a clinical study conducted with 3 doses of the current formulation in adults, the incidence of pain, redness, swelling, fatigue, gastro-enteritis, headache and fever was comparable to the incidence observed with the former thiomersal and preservative containing vaccine formulation. The following adverse reactions have been reported following the widespread use of the former formulation"
Section 5.1 - Deleted "These data were generated with the former Ambirix formulation containing thiomersal and a preservative. A clinical study conducted with 3 doses of the current formulation in adults showed that the current formulation elicited similar seroprotection and seroconversion rates as compared to the former formulation."
Section 6.1 - Reintroduced "phenoxyethanol"
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Updated on 03/02/2009 and displayed until 17/02/2009
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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 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 05-Sep-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Deleted "Thiomersal (an organomercuric compound) has been used in the manufacturing process of this medicinal product and residues of it are present in the final product. Therefore, sensitisation reactions may occur."
Section 4.8 - Added "The current formulation of Ambirix does not contain thiomersal (an organomercuric compound) or any preservative. In a clinical study conducted with 3 doses of the current formulation in adults, the incidence of pain, redness, swelling, fatigue, gastro-enteritis, headache and fever was comparable to the incidence observed with the former thiomersal and preservative containing vaccine formulation. The following adverse reactions have been reported following the widespread use of the former formulation"
Section 5.1 - Added "These data were generated with the former Ambirix formulation containing thiomersal and a preservative. A clinical study conducted with 3 doses of the current formulation in adults showed that the current formulation elicited similar seroprotection and seroconversion rates as compared to the former formulation."
Section 6.1 - Deleted "phenoxyethanol"
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Updated on 08/01/2008 and displayed until 03/02/2009
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Reasons for adding or updating:
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