Kisqali 200 mg film-coated tablets *
Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal 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