Zykadia 150 mg hard capsules
- Name:
Zykadia 150 mg hard capsules
- Company:
Novartis Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/01/20
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Novartis Ireland Limited
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 30 January 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 30 January 2020 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 increased from 2 years to 3 years
Updated on 10 April 2019 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
Updated on 10 April 2019 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Minor editorial changes to Sections 4.2, 6.1 and 6.5.
Updated on 21 March 2019 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 21 March 2019 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Revision of recommendations for concomitant use of Zykadia with CYP3A and CYP2C9 substrates based on A2103 drug interaction study results.
Changes to the list of examples of CYP3A substrates with narrow therapeutic index (NTI) {addition of alfuzosin, amiodarone, dihydroergotamine, quetiapine, lovastatin, simvastatin, sildenafil, midazolam, triazolam and deletion of astemizole}
Updated on 4 September 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 26 July 2018 SmPC
Reasons for 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 5.2 - Pharmacokinetic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 3 July 2018
Updated on 23 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 September 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 16 September 2015 PIL
Reasons for updating
- Change to side-effects
Updated on 3 September 2015 PIL
Reasons for updating
- Introduction of new pack/pack size
Updated on 10 June 2015 PIL
Reasons for updating
- New PIL for new product