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Actelion Pharmaceuticals UK Ltd

Chiswick Tower 13th Floor, 389 Chiswick High Road, London, W4 4AL, UK
Telephone: +44 (0)208 987 3333
Fax: +44 (0)208 987 3322
WWW: http://www.actelion.com
Medical Information Direct Line: +44 (0)208 987 3333
Medical Information e-mail: medinfo_uk@actelion.com
Summary of Product Characteristics last updated on medicines.ie: 12/10/2017
SPC Zavesca 100mg hard capsules

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 12/10/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Date of revision of text on the SPC:   31-Jul-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

$0Zavesca 100 mg capsules$0
Updated on 07/10/2016 and displayed until 12/10/2017
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Aug-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Change of batch release address
Updated on 08/03/2016 and displayed until 07/10/2016
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   14-Oct-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

$0Reportingof suspected adverse reactions$0$0Reportingsuspected adverse reactions after authorisation of the medicinal product isimportant. It allows continued monitoring of the benefit/risk balance of themedicinal product. Healthcare professionals are asked to report any suspectedadverse reactions via the national reporting system listed below.$0$0 $0$0United Kingdom$0$0Yellow Card Scheme$0$0Website: www.mhra.gov.uk/yellowcard$0$0 $0$0Ireland$0$0HPRAPharmacovigilance$0$0Earlsfort Terrace$0$0IRL - Dublin 2$0$0Tel: +353 1 6764971$0$0Fax: +353 1 6762517$0$0Website: www.hpra.ie$0$0e-mail: medsafety@hpra.ie$0$0 $0$0Malta$0$0ADRReporting$0$0The MedicinesAuthority $0$0Post-LicensingDirectorate$0$0203 Level 3, Rue D'Argens$0$0GŻR-1368 Gżira$0$0Website: www.medicinesauthority.gov.mt$0$0e-mail:postlicensing.medicinesauthority@gov.mt$0
Updated on 25/06/2014 and displayed until 08/03/2016
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   30-Apr-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

$0Reportingof suspected adverse reactions$0$0Reportingsuspected adverse reactions after authorisation of the medicinal product isimportant. It allows continued monitoring of the benefit/risk balance of themedicinal product. Healthcare professionals are asked to report any suspectedadverse reactions via thenational reporting system listed below.$0$0 $0$0United Kingdom$0$0Yellow Card Scheme$0$0Website: www.mhra.gov.uk/yellowcard$0$0 $0$0Ireland$0$0Pharmacovigilance Section $0$0Irish Medicines Board $0$0Kevin O’Malley House $0$0Earlsfort Centre $0$0Earlsfort Terrace $0$0IRL - Dublin2$0$0Tel: +353 1 6764971$0$0Fax: +353 1 6762517$0$0Website: www.imb.ie$0$0e-mail: imbpharmacovigilance@imb.ie$0$0 $0$0Malta$0$0ADR Reporting$0$0The Medicines Authority $0$0Post-Licensing Directorate$0$0203 Level 3, Rue D'Argens$0$0GŻR-1368 Gżira$0$0Website: www.medicinesauthority.gov.mt$0$0e-mail: postlicensing.medicinesauthority@gov.mt$0
Updated on 03/09/2013 and displayed until 25/06/2014
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12-Aug-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change of date of text to August 2013
Updated on 13/02/2013 and displayed until 03/09/2013
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Feb-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Shelf life changed from 3 years to 5 years
Updated on 06/02/2013 and displayed until 13/02/2013
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Aug-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change of date to revision of text
Updated on 12/01/2012 and displayed until 06/02/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Dec-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.8 (undesirable effects) was rewritten and the following undesirable effects were added - depression, amnesia, muscle weakness and chills and malaise

Section 5.1 (pharmacodynamic properties) now includes a paragraph detailing an open-label, non-comparative, 2-year study in 42 patients with type 1 Gaucher disease
Updated on 20/06/2011 and displayed until 12/01/2012
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   16-May-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Annual EMA reassessment completed and revision date updated accordingly
Updated on 30/07/2010 and displayed until 20/06/2011
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Annual reassessment of the product

Updated on 15/12/2009 and displayed until 30/07/2010
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   26-May-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In Section 10 DATE OF REVISION OF THE TEXT, the date was updated due to the annual re-assessment of the product information.
Updated on 11/02/2009 and displayed until 15/12/2009
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

In section 4.1, there was specification of treatment of type 1 Gaucher disease in adults only, and addition of new indication for treatment of progressive neurological manifestations of Niemann-Pick Type C disease in both paeds and adults.
 
In section 4.2, there was revision to dosage instructions that are specific to treatment of type 1 Gaucher disease, and NPC.
 
In section 4.4, precautions in the treatment of type 1 Gaucher disease were updated, and new advice for treatment of NPC patients.
 
In section 4.5, there was a small grammatical correction.
 
In section 4.8, there were small revisions.
 
In section 5.1, there were revisions to the information for treatment of Gaucher disease type 1, and new information provided regarding treatment of NPC patients.
 
In section 5.2, there were extensive updates relating to new data.
 
In section 5.3, there were grammatical corrections.
 
In section 10, the date was changed in light of these updates.
Updated on 07/11/2008 and displayed until 11/02/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

The efficacy and safety of Zavesca has not been specificallyevaluated in patients with severe Gaucher disease.

 

5.1 Pharmacodynamic properties

"...29 patients continued in the extension period. When compared to the measurements at 6 moths, disease control was unchanged after 18 and 24 months of Zavesca monotherapy (20 and 6 patients, respectively). No patient showed rapid deterioration of type 1 Gaucher disease following the switch to Zavesca monotherapy.

A total daily dose of 300 mg Zavesca administered in three divided doses was used in the above two studies. An additional monotherapy study was performed in 18 patients at a total daily dose of 150 mg, and results indicate reduced efficacy compared to a total daily dose of 300 mg.

Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical studies in patients treated with miglustat 100 mg t.i.d. for up to 2 years (n = 72). In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements. There were no events of bone crisis, avascular necrosis or fracture during the treatment period."

Updated on 25/06/2008 and displayed until 07/11/2008
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Miglustat