Zavesca 100mg hard capsules
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 08 November 2024
File name
IE_Zavesca_PIL_20241025_61(3)_clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Update contact details i.e. phone number from +353 to 1 800 709 122
Updated on 13 December 2023
File name
NI and IE-Zavesca-SmPC-II-076-Nov 2023.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
-Section 4.4 – Crohn’s disease paragraph
-Section 4.4 – reduced growth headline
Updated on 13 December 2023
File name
NI and IE-Zavesca-PIL-EUPI-II-076-Nov-2023.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 08 February 2023
File name
NI and IE Zavesca SmPC C03 Day27 18Aug21 Clean EDMS-ERI-205912882 V13.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 August 2021
File name
NI and IE Zavesca SmPC C03 Day27 18Aug21 Clean EDMS-ERI-205912882 V13.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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
- Update to pregnancy and lactation wording
- Correction in line with CCDS and QRD update
Updated on 18 August 2021
File name
NI and IE Zavesca PIL C03 Day27 18Aug21-Clean EDMS-ERI-205912882 V13.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- Change to manufacturing site responsible for batch release,
- changes in local representatives,
- Correction in line with CCDS and QRD update
Updated on 11 November 2020
File name
Zavesca SmPC C02 CHMP 03 Nov 20 clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated section 4.4 to align with EU Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products'. The excipient concerned is Sodium.
Updated on 11 November 2020
File name
IRE Zavesca PIL C02 CHMP 03 Nov 20 clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Updated section 2 to align with EU Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products'. The excipient concerned is Sodium.
Updated on 24 February 2020
File name
Zavesca SmPC C01 CHMP 21 Feb 2020-Clean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Correction of the renewal date in section 9. Alignment to QRD v10.1 and linguistic corrections.
Updated on 24 February 2020
File name
Zavesca-PIL C01 CHMP 21 Feb 2020 Clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Correction of spelling/typing errors
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
Deletion of Actelion Pharmaceuticals Belgium NV as manufacturer responsible for batch release.
Addition of Janssen Pharmaceutica NV as manufacturer responsible for batch release not including batch control/testing.
Alignment to QRD v10.1 and linguistic corrections.
Updated on 30 November 2018
File name
EN-Zavesca_H-435_Notification61(3)_clean_AppV_PI-I-III-21November2018 PIL.pdf
Reasons for updating
- Change to other sources of information section
Updated on 17 October 2018
File name
EN_Zavesca_H-435_MAH-Transfer_clean_AppV_PI_I-III_02October2018 PIL.pdf
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
File name
EN_Zavesca_H-435_MAH-Transfer_clean_AppV_PI_I-III_02October2018 SPC.pdf
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
File name
Zavesca_SmPC_03May2018docx.docx
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 08 May 2018
File name
Zavesca_PIL_03May2018.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 01 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 December 2017
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
Updated on 29 November 2017
File name
PIL_13166_467.pdf
Reasons for updating
- New PIL for new product
Updated on 29 November 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 12 October 2017
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
Updated on 12 October 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 07 October 2016
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
Updated on 22 September 2016
Reasons for updating
- Change to date of revision
Updated on 08 March 2016
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
Updated on 19 October 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 25 June 2014
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
Updated on 20 June 2014
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 03 September 2013
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
Updated on 28 August 2013
Reasons for updating
- Change to date of revision
Updated on 13 February 2013
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
Updated on 06 February 2013
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
Updated on 29 August 2012
Reasons for updating
- Change to date of revision
Updated on 12 January 2012
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 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
Reasons for updating
- Change to side-effects
Updated on 20 June 2011
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
Updated on 16 June 2011
Reasons for updating
- Change to date of revision
Updated on 30 July 2010
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
Reasons for updating
- Change to date of revision
Updated on 15 December 2009
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
Updated on 10 December 2009
Reasons for updating
- Change to date of revision
Updated on 11 February 2009
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
Updated on 10 February 2009
Reasons for updating
- Changes to therapeutic indications
Updated on 07 November 2008
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
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
Reasons for updating
- New PIL for medicines.ie