Summary of Product Characteristics
last updated on the eMC:
04/03/2009
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 04/03/2009 and displayed until Current
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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 4.3 - Contraindications
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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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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: 27-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - Update to recommend two doses in children aged 1 to 12 years
Section 4.3 - Further detail supporting the contra-indication in immuno-compromised subjects
Section 4.8 - Update regarding reactogenicity after second dose
Section 5.1 - Further information regarding antibody levels following a second dose
Section 6.1 - Minor adminstrative edits
Section 6.6 - Heading change to bring in line with SPC template
Section 10 - Date of revision changed to 27 February 2009
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Updated on 25/11/2008 and displayed until 04/03/2009
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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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 4.9 - Overdose
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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-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.3 - Additional sentence last paragraph: In healthy subjects the presence of a minor infection, however, is not a contraindication.
Section 4.5 - New 4th Paragraph:If a measles containing vaccine is not given at the same time as Varilrix, it is recommended that an interval of at least one month between vaccinations is respected, since it is recognised that measles vaccination may cause short-term suppression of the cell-mediated response.
Section 4.8 - The whole of this section with MedRA terminology & frequencies
Section 4.9 - The whole of this section
Section 10 - Approved 29 October 2008
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Updated on 15/08/2006 and displayed until 25/11/2008
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 22/10/2004 and displayed until 15/08/2006
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 22/09/2004 and displayed until 22/10/2004
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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 02/08/2002 and displayed until 22/09/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 31/07/2002 and displayed until 02/08/2002
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Reasons for adding or updating:
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