Zavesca 100mg hard capsules

When a pharmaceutical company changes any document, 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 30 November 2018 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 17 October 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 17 October 2018 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Summary of Changes

Section 4.8:

 Addition of:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed below.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

 

Section 7:

Removal of:

Actelion Registration Ltd

Chiswick Tower 13th Floor

389 Chiswick High Road

London W4 4AL

United Kingdom

 

Addition of:

Janssen-Cilag International NV

Turnhoutseweg 30

B 2340 Beerse

Belgium

 

Section 10:

Date of revision of text: October 2018

Updated on 16 May 2018 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 8 May 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 1 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 1 December 2017 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of site batch release

Updated on 29 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 November 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 October 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 October 2017 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

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 7 October 2016 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

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 22 September 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 8 March 2016 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

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 19 October 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 25 June 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

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 20 June 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 3 September 2013 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change of date of text to August 2013

Updated on 28 August 2013 PIL

Reasons for updating

  • Change to date of revision

Updated on 13 February 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Shelf life changed from 3 years to 5 years

Updated on 6 February 2013 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change of date to revision of text

Updated on 29 August 2012 PIL

Reasons for updating

  • Change to date of revision

Updated on 12 January 2012 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

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 10 January 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 20 June 2011 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Annual EMA reassessment completed and revision date updated accordingly

Updated on 16 June 2011 PIL

Reasons for updating

  • Change to date of revision

Updated on 30 July 2010 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Annual reassessment of the product

Updated on 26 July 2010 PIL

Reasons for updating

  • Change to date of revision

Updated on 15 December 2009 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

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 10 December 2009 PIL

Reasons for updating

  • Change to date of revision

Updated on 11 February 2009 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 10 February 2009 PIL

Reasons for updating

  • Changes to therapeutic indications

Updated on 7 November 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

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 June 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 20 May 2008 PIL

Reasons for updating

  • New PIL for medicines.ie