Summary of Product Characteristics
last updated on the eMC:
10/06/2010
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 10/06/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 01-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- in section 2.......the correct symbol ≥ is now used instead of the previos =
- in section 2 - a typo has been corrected in the word 'purified'
- in section 6.5, the English form of the words (polypropylene) and (polyethylene) are used instead of the previous versions
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Updated on 09/05/2010 and displayed until 10/06/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- In section 4.8 (undesirable effects), a typographical error has now been corrected for the 'dizziness' category to correctly inlcude the frequencies for 'uncommon' as >1/1000, <1/100. Previoulsy one of the '>' symbols was incorrectly placed
This did not require a new 'date of revision of tex' (section 10)
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Updated on 12/03/2010 and displayed until 09/05/2010
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 6.2 - Incompatibilities
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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-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- In section 1, the type of product has been changed to ' rabies vaccine, inactivated'
- In section 6.2, the text has now changed to
In the absence of compatibility studies, Rabipur must not be mixed in the same syringe with other medicinal products. No interactions with concomitant administration of other vaccines have been reported.
- In section 10, the date of (partial) revision of the text has been updated to February 2009
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Updated on 18/02/2008 and displayed until 12/03/2010
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.5 the folloiwng added "... syringe (polypropylen with polyethylen plunger)"
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Updated on 31/08/2004 and displayed until 18/02/2008
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Reasons for adding or updating:
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