Summary of Product Characteristics
last updated on the eMC:
05/05/2011
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 05/05/2011 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 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 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: 01-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 4.2 Posology and method of administration
The booster duration has been increased from 4 years to 10 years - This is preferably given between 6-12 months after the first dose but may be given up to 10 years later based on limited experience in healthy adult travellers (see section 5.1).
In section 4.4 Special warnings and precautions for use
Epaxal may contain traces of polymyxin B has been added.
In section 4.8 Undesirable effects
The most common adverse reactions are fatigue, injection site pain and headache, which have been shown in clinical studies to occur at frequencies of 6-32%, 5 – 25% and 6 – 25% respectively. has been added.
In section 6.6 Special precautions for disposal and other handling
Shake before use has been added.
In section 10. DATE OF REVISION OF THE TEXT
2011-01-04 is the latest text revision.
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Updated on 22/12/2010 and displayed until 05/05/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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: 03-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Marketing authorisation holder now:
Crucell Italy S.r.l.
Via Zambeletti 25
IT - 20021 Baranzate (MI)
Italy
Date of revision of text is: 03/12/2010
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Updated on 26/05/2010 and displayed until 22/12/2010
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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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| Date of revision of text on the SPC: 10-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 5.1 Duration of protection has been changed from 20 years to 30 years
In section 10 date is now 10/03/2010
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Updated on 28/09/2007 and displayed until 26/05/2010
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.3 the shelf life has changed from 2 to 3 years
Section 4.8 minor updates to wording
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Updated on 12/01/2005 and displayed until 28/09/2007
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Updated on 18/08/2003 and displayed until 12/01/2005
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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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SPC Retired pending re-submission
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