Summary of Product Characteristics
last updated on the eMC:
17/05/2011
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 17/05/2011 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: 09-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The only change to this SmPC is the date of revision of text to 09 June 2010.
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Updated on 28/01/2010 and displayed until 17/05/2011
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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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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 24-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.5
Updated to include the addition of two new pack sizes:
Pack sizes
- Unit pack containing 14 vials with powder and 14 pre-filled syringes with solvent
- 3-month multipack containing 42 (3x14) vials with powder and 42 (3x14) pre-filled syringes with solvent
Section 8
Addition of MA numbers for the two new pack sizes in section 8:
EU/1/08/454/006
EU/1/08/454/007
Section 10 updated with new date of revision.
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Updated on 21/04/2009 and displayed until 28/01/2010
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Reasons for adding or updating:
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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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| None provided |
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