Summary of Product Characteristics
last updated on the eMC:
22/01/2010
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 22/01/2010 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 3 - Pharmaceutical form
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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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: 17-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
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Free-text change information supplied by the pharmaceutical company
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Section 2: Rephrased from "Levomepromazine maleate INN (methotrimeprazine maleate BAN) 25mg per tablet." to "Levomepromazine maleate 25mg per tablet. For excipients, see 6.1."
Section 3: Added detail about tablet: "Circular, grey-white or cream biconvex uncoated tablet. One face with Nozinan around a central 25 and a breakline on the reverse."
Section 5.1: Added the following: " ATC Code: NO5AA02. Pharmacotherapeutic group: Antipsychotics."
Section 6.1 "sodium lauryl sulphate" changed to "Sodium lauryl sulfate"
Date of revision changed to 17/11/09.
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Updated on 28/06/2006 and displayed until 22/01/2010
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 04/08/2005 and displayed until 28/06/2006
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 24/03/2004 and displayed until 04/08/2005
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 17/12/2003 and displayed until 24/03/2004
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 20/08/2001 and displayed until 17/12/2003
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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