Summary of Product Characteristics
last updated on the eMC:
28/09/2007
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 28/09/2007 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 09/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7: Company name change from ZLB Behring to CSL Behring
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Updated on 19/07/2006 and displayed until 28/09/2007
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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 4.4 - Special Warnings and Precautions for Use
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Change to section 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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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: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 - included concentration of 750IU (150 mcg)
Section 4.4 - revised Information on safety with respect to transmissible agents
Section 8 - Included new PL nubmer PL15036/0019
Section 9 - Renewal of product licence, hence renewal date changed
Section 10 - Text revision date updated
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Updated on 19/12/2003 and displayed until 19/07/2006
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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 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 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 03/10/2003 and displayed until 19/12/2003
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 23/04/2003 and displayed until 03/10/2003
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Reasons for adding or updating:
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