Summary of Product Characteristics
last updated on the eMC:
28/11/2008
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 28/11/2008 and displayed until Current
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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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| Date of revision of text on the SPC: 01-Dec-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 10 – Date of revision updated.
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Updated on 07/02/2008 and displayed until 28/11/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 03/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 - updated the address of the Marketing Authorisation Holder.
Section 10 - changed date of revision to March 2007
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Updated on 22/08/2006 and displayed until 07/02/2008
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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Change to section 3 - pharmaceutical form
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Change to section 4.2 - Posology and Method of Administration
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.2 - Incompatibilities
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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: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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· Section 1 - update to name
· Section 2 - words updated for clarification
· Section 3 - updated to include description of pharmaceutical form
· Section 4.2 Booster – recommendations on a booster dose have been amended.
· Section 4.2 Special dosage recommendation for known of presumed exposure to hepatitis B virus - the recommendations for serologic testing, and administration of additional doses if needed have been strengthened.
· Section 4.2 Method of administration - updated to ensure vaccine not injected intravascularly and reference to see section 6.6 for instructions for preparation.
· Section 5.1 – additional information provided on clinical trials and booster doses.
· Section 6.2 – wording change for clarification
· Section 6.6 – inclusion of additional sentence with regards to disposal of waste.
· Section 10 – update to date of revision of the text
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Updated on 20/06/2005 and displayed until 22/08/2006
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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 (partial) revision of the text
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Updated on 27/04/2005 and displayed until 20/06/2005
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Change to section 7 - Marketing Authorisation Holder
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Updated on 25/09/2002 and displayed until 27/04/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 07/08/2002 and displayed until 25/09/2002
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Reasons for adding or updating:
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