Summary of Product Characteristics
last updated on the eMC:
28/06/2006
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 28/06/2006 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 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 6. 4 - Special Precautions for Storage
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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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4.4 Excipient warning regarding lactose added.
4.5 Change from the BAN to INN name for cyclosporine.
6.4 Change to the storage conditions wording.
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Updated on 09/01/2006 and displayed until 28/06/2006
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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 (partial) revision of the text
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Updated on 06/01/2006 and displayed until 09/01/2006
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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 (partial) revision of the text
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Updated on 22/07/2004 and displayed until 06/01/2006
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Change to section 6.1 - List of Excipients
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Updated on 30/12/2003 and displayed until 22/07/2004
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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 10 (date of (partial) revision of the text
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Updated on 25/09/2003 and displayed until 30/12/2003
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Reasons for adding or updating:
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Change to joint SPC covering all presentations
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Updated on 24/09/2002 and displayed until 25/09/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 06/08/2002 and displayed until 24/09/2002
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Reasons for adding or updating:
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Addition of Legal Category
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Updated on 07/08/2001 and displayed until 06/08/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 13/02/2001 and displayed until 07/08/2001
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Reasons for adding or updating:
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Updated on 25/02/2000 and displayed until 13/02/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 25/02/2000
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Reasons for adding or updating:
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