Vastarel 20mg
- Name:
Vastarel 20mg
- Company:
Servier Laboratories Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/05/20
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Servier Laboratories Ireland Ltd
Company Products
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 19 May 2020 SmPC
Reasons for updating
- Improved presentation of SmPC
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 19 May 2020 PIL
Reasons for updating
- Change due to harmonisation of PIL
Updated on 20 November 2018 PIL
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 20 November 2018 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 27 June 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 26 June 2018 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 26 June 2018 PIL
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 15 January 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 15 January 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 15 January 2018 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
4.4. Special warnings and precautions for use
6.1. List of excipients
Updated on 15 January 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 6 - what the product looks like and pack contents
Updated on 3 August 2017 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
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
Updated on 1 August 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 17 August 2016 SmPC
Reasons for updating
- Removal of black triangle
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 28 June 2016 PIL
Reasons for updating
- Removal of black triangle
Updated on 14 December 2015 PIL
Reasons for updating
- Change to further information section
Updated on 18 November 2015 SmPC
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 5.2 (Preclinical safety data)
Chronic toxicity studies conducted by the oral route in dogs (5 to 40 mg.kg-1.d-1) and rats (5 to 200 mg.kg-1.d-1), showed a good safety profile.
Neither embryo-foetotoxic effects nor teratogenicity were detected in mice and in rabbits. The general study on reproduction and embryogenesis in 3 generations of rats showed no anomalies. The genotoxic potential was thoroughly assessed with three in vitro studies including the evaluation of the mutagenic and clastogenic potential and one in vivo study. All tests were negative.
Updated on 3 October 2014 PIL
Reasons for updating
- Addition of information on reporting a side effect.
- Addition of black triangle
Updated on 22 September 2014 SmPC
Reasons for updating
- Addition of black triangle
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 18 February 2014 PIL
Reasons for updating
- Addition of information on reporting a side effect.
- Addition of black triangle
Updated on 10 February 2014 SmPC
Reasons for updating
- Addition of black triangle
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 5 March 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to information about driving or using machinery
- Change of contraindications
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
- Change to improve clarity and readability
Updated on 8 October 2012 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 4 March 2011 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 3 December 2009 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to how the medicine works
- Change to date of revision
- Change to improve clarity and readability
- Change of special precautions for disposal
Updated on 18 February 2008 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 5 June 2007 PIL
Reasons for updating
- Change to date of revision
Updated on 5 June 2007 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 20 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 11 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)