Summary of Product Characteristics
last updated on the eMC:
10/12/2009
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 10/12/2009 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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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 6. 5 - Nature and Contents of Container
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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: 23-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Updated to include a warning about syncope
Section 4.5 - New information on co-administration with a combined hepatitis A + B vaccine
Section 4.8 - Post-marketing undesirable effects added
Section 6.6 - Updated to include illustrated instructions for use of the pre-filled syringe.
Section 10 - Approval Date
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Updated on 14/08/2009 and displayed until 10/12/2009
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 24-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 - Two new paragraphs under " Use with other vaccines"
Section 10 - Date 24 July 2009
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Updated on 08/05/2009 and displayed until 14/08/2009
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 10 date of revision of the text
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Addition of link to EMEA website
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| Date of revision of text on the SPC: 22-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 6.3 - Shelf life extended. Addition of cold chain break information
Section 10 - Updated
Section 11 - Reference to EMEA website for further information
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Updated on 02/09/2008 and displayed until 08/05/2009
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Reasons for adding or updating:
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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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Change to section 4.1 - Therapeutic indications
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| Date of revision of text on the SPC: 13-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 - rewording of the indication statement including reference to 'premalignant cervical leesions'
Section 5.1 - update with information on long term data, update to pharmacotherapeutic group and explanation of term 'premalignant cervical lesions'
Section 10 - date of Commission Decision
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Updated on 24/09/2007 and displayed until 02/09/2008
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Reasons for adding or updating:
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