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Novartis Ireland Limited
Beech House, Beech Hill Office Campus, Clonskeagh, Dublin 4,
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 29/07/2011
SPC Clozaril tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 29/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to joint SPC covering all presentations
Date of revision of text on the SPC:   30-Apr-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Update to SPC
Updated on 10/11/2009 and displayed until 29/07/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Date of revision of text on the SPC:   02-Feb-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
This SPC was corrected as some text had been cut off during formatting of the SPC -

the following sentence  was missing from Section 1 of the SPC on the medicines.ie website:  ‘Clozaril can cause agranulocytosis. Its use should be limited to patients:’
Updated on 26/03/2009 and displayed until 10/11/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
4.2 Delete sentence wrt other strengths as it is a combined SPC and details of both strengths are already included.
Updated on 13/03/2009 and displayed until 26/03/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Updates include general formatting and text changes e.g.should is replaced with must
4.1Statement on Availability of other strengths and statement on unsuitability for adolscents
4.4 Header for lactose  warning
Statement on increased risk of cerebrovascular events, antipsychotic warnings re cardiovascular disease, QT prolongation or prescribing with medicines known to increase QTc intervals.
4.5 Inclusion of statement on interactions with drugs known to increase or  inhibit CYP1A2
4.8 inclusion of a possible very rare side effect QT prolongation associated with Torsades de Pointes
5.1 Name of the pharotherapeutic group updated
6.5 Hospital pack size defined and details of closure for glass bottles included. 
Updated on 09/05/2006 and displayed until 13/03/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Updated on 16/08/2005 and displayed until 09/05/2006
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Updated on 21/07/2003 and displayed until 16/08/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Clozapine