Kisqali 200 mg film-coated tablets * Pharmacy Only: Prescription
Company:
Novartis Ireland LimitedStatus:
UpdatedLegal 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
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