Glivec 100mg and 400mg 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):
*Additional information is available within the SPC or upon request to the company
Updated on 31 July 2024
File name
Glivec_REG PIL_PF24-0025 Ljubljana clean.pdf
Reasons for updating
- New PIL for new product
Updated on 17 October 2023
File name
Glivec_REG SPC_PF23-0175_31.08.2023_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 March 2023
File name
Glivec FCT REGSPC PF23-0073 _March 2023 Clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 March 2022
File name
Glivec FCT REGSPC PF22-0070_March 2022_Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 December 2021
File name
Glivec FCT PF21-0315 REGSPC Dec 2021_Clean.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 August 2021
File name
Glivec REGSPC PF21-0212-IA-0126_Clean_11.08.2021.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 July 2020
File name
Glivec FCT REGSPC PF 20-0128_Clean .pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 April 2019
File name
Glivec_100mg_400mg_FCTab_28-Mar-19_English_Clean signed.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 18 July 2018
File name
REG_SmPC_Glivec_100mg_400mg_FCTab.pdf
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 02 July 2018
File name
GlivecFCTII-109_Clean_April_2018.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 May 2018
File name
GlivecFCTII-109_Clean_April_2018.docx
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 April 2018
File name
GlivecFCTII-109_Clean_April_2018.docx
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 October 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 October 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Additional information under “Paediatric population”
Updated on 11 October 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
Additional information under “Paediatric population”
Updated on 08 December 2016
Reasons for updating
- Addition of joint SPC covering all presentations
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 December 2016
Reasons for updating
- Addition of joint SPC covering all presentations
Free text change information supplied by the pharmaceutical company
Novartis Ireland Limited
Address:
Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, IrelandMedical Information E-mail:
medinfo.dublin@novartis.comTelephone:
+353 1 2601255Fax:
+353 1 2601263