Kisqali 200 mg film-coated tablets *

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

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

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 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