Summary of Product Characteristics
last updated on the eMC:
25/01/2012
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 25/01/2012 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 10 date of revision of the text
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| Date of revision of text on the SPC: 23-Jan-2012 |
| 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 19/08/2011 and displayed until 25/01/2012
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Reasons for adding or updating:
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New individual SPC (was previously included in combined SPC)
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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1.
Engerix Bâ 20 micrograms/1 ml
Suspension for injection
Hepatitis B (rDNA) vaccine, adsorbed (HBV)
6.5 Addition of pack sizes
10. Revision date change
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