Summary of Product Characteristics
last updated on the eMC:
18/09/2007
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 18/09/2007 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: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change of product licence holder to trading style of sanofi aventis
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Updated on 21/09/2006 and displayed until 18/09/2007
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.1 (List of excipients): Change to the specification of Lactose anhydrous ffrom USP to Ph. Eur.
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Updated on 04/08/2006 and displayed until 21/09/2006
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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: 03/2003 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 (undesirable effects): Liver function: Liver injury has been reported very rarely in in patients treated with pericyazine.
Section 4.8 (undesirable effects): Liver function: Neuroleptic jaundice has the biochemical and other characteristics of obstructive (cholestatic) jaundice....
Section 4.8 (undesirable effects): Priapism has very rarely been reported in patients treated with pericyazine.
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Updated on 24/09/2004 and displayed until 04/08/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 24/09/2004 and displayed until 24/09/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 24/09/2004 and displayed until 24/09/2004
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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