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Kisqali 200 mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Ribociclib Succinate

    *Additional information is available within the SPC or upon request to the company

  • Kisqali 200 42s-1.png
  • Kisqali 200 63s-1.png

Updated on 29 July 2022

File name

62e3e7ec7e227.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Updated on 29 July 2022

File name

62e3e7812cca9.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 22 April 2022

File name

Kisqali_REG PIL_PF22-0085_04.04.2022_clean_1650625493.pdf

Reasons for updating

  • Removal of Black Inverted Triangle
  • Change to side-effects

Updated on 22 April 2022

File name

Kisqali_REG SPC_PF22-0085_04.04.2022_clean_1650625224.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Removal of Black Inverted Triangle

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

Updated on 26 January 2022

File name

Kisqali 200mg REG PIL_PF 21-0271_Clean_1643213162.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to marketing authorisation holder

Updated on 04 August 2021

File name

Kisqali_REG SPC_PF21-0186_28.05.2021_clean_1628071138.pdf

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Updated on 05 November 2020

File name

REG PIL PF20-0241 October 2020 TBI 17.07.2021_1604595517.pdf

Reasons for updating

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

Updated on 05 November 2020

File name

Kisqali REG SPC PF 20-0241 October 2020clean_1604595080.pdf

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

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

Updated on 22 July 2020

File name

PIL Kisqali PF 19-0264 July 2020 IPHA_1595413267.pdf

Reasons for updating

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

Updated on 22 July 2020

File name

PIL Kisqali PF 19-0264 July 2020 IPHA_1595413226.pdf

Reasons for updating

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

Updated on 22 July 2020

File name

Kisqali REG SPC PF 19-0264 July 2020 clean_1595412211.pdf

Reasons for updating

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

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

Updated on 09 June 2020

File name

Kisqali 200mg REG PIL PF 19-0265 TBI Feb 2021_1591707850.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 09 June 2020

File name

Kisqali REG SPC PF 19-0265 april 2020 clean_1591707581.pdf

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

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

Updated on 13 May 2020

File name

Kisqali Leaflet REG PIL PF 19-0263 FEB 2020 IPHA_1589361156.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 30 March 2020

File name

Kisqali 200mg REG PIL_2220376_R91_IPHA_1575549323.pdf

Reasons for updating

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

Updated on 30 March 2020

File name

Kisqali REG SPC PF 19-0263 February 2020 cleanIPHA_1585577899.pdf

Reasons for updating

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

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

Updated on 05 December 2019

File name

Kisqali 200mg REG PIL_2220376_R91_IPHA_1575549323.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 24 September 2019

File name

Kisqali_200mg_REG SmPC_PF 19-0142_IPHA_1569333291.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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 August 2019

File name

Kisqali_200mg_REG SmPC_PF 19-0141_IPHA_1565275102.pdf

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

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

Updated on 27 May 2019

File name

Kisqali_200mg_REG SmPC_PF 19-0113_IPHA_1558962571.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 11 February 2019

File name

Kisqali 200mg REG PIL_2220376_R91_IPHA_1549880953.pdf

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

File name

Kisqali_200mg_REG SmPC_PF 18-0201_clean_IPHA_1548671253.pdf

Reasons for updating

  • Other

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

Updated on 08 January 2019

File name

Kisqali 200mg REG PIL_2217067_R91_IPHA_1546949074.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 08 January 2019

File name

Kisqali_200mg_REG SmPC_PF 18-0201_clean_1546950173.pdf

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

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

Updated on 09 May 2018

File name

Kisqali200mgREGSmPC_PF18-0074_Clean.docx

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 SPC for new product

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

Updated on 09 November 2017

File name

PIL_17350_568.pdf

Reasons for updating

  • New PIL for new product