Kisqali 200 mg film-coated tablets | Doc History | Novartis Ireland Limited

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Kisqali 200 mg film-coated tablets

Name:
Kisqali 200 mg film-coated tablets
Company:
Novartis Ireland Limited
Active Ingredients:
Ribociclib succinate
Legal Category:
Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/11/20

Summary of Product Characteristics last updated on medicines.ie: 5/11/2020

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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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 5 November 2020 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions

Updated on 5 November 2020

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 4.5 - Interaction with other medicinal products and other forms of interaction

Updated on 22 July 2020 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions

Updated on 22 July 2020 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions

Updated on 22 July 2020

Reasons for updating

Change to section 4.2 - Posology and method of administration
Change to section 4.4 - Special warnings and precautions for use

Updated on 9 June 2020 PIL

Reasons for updating

Change to section 4 - possible side effects

Updated on 9 June 2020

Reasons for updating

Change to section 4.8 - Undesirable effects
Change to section 5.1 - Pharmacodynamic properties
Change to section 10 - Date of revision of the text

Updated on 13 May 2020 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions
Change to section 6 - date of revision

Updated on 30 March 2020 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions

Updated on 30 March 2020

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 4.8 - Undesirable effects

Updated on 5 December 2019 PIL

Reasons for updating

Improved presentation of PIL

Updated on 24 September 2019

Reasons for updating

Change to section 5.1 - Pharmacodynamic properties
Change to section 10 - Date of revision of the text

Updated on 8 August 2019

Reasons for updating

Change to section 4.2 - Posology and method of administration
Change to Section 4.8 – Undesirable effects - how to report a side effect
Change to section 5.2 - Pharmacokinetic properties
Change to section 10 - Date of revision of the text

Updated on 27 May 2019

Reasons for updating

Change to section 6.3 - Shelf life
Change to section 10 - Date of revision of the text

Updated on 11 February 2019 PIL

Reasons for updating

Change to section 1 - what the product is used for
Change to section 2 - interactions with other medicines, food or drink
Change to section 2 - pregnancy, breast feeding and fertility
Change to section 3 - dose and frequency
Change to section 4 - possible side effects
Change to section 6 - date of revision

Updated on 28 January 2019

Reasons for updating

Other

Updated on 8 January 2019 PIL

Reasons for updating

Change to section 6 - marketing authorisation holder

Updated on 8 January 2019

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 4.6 - Pregnancy and lactation
Change to section 4.7 - Effects on ability to drive and use machines
Change to Section 4.8 – Undesirable effects - how to report a side effect
Change to section 4.9 - Overdose
Change to section 5.1 - Pharmacodynamic properties
Change to section 5.3 - Preclinical safety data

Updated on 9 May 2018

Reasons for updating

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)

Updated on 13 November 2017

Reasons for updating

New SmPC for new product

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

Updated on 9 November 2017 PIL

Reasons for updating

New PIL for new product