Glivec 100mg and 400mg 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 20 August 2021

File name

Glivec REGSPC PF21-0212-IA-0126_Clean_11.08.2021_1629475715.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 20 August 2021

File name

Glivec REGPIL PF21-0212-IA-0126_Clean_11.08.2021_1629475657.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 July 2020

File name

Glivec FCT REGSPC PF 20-0128_Clean _1593599406.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_1554375733.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

In Section  4.4        Special warnings and precautions for use

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

In Section  4.4        Special warnings and precautions for use

Additional information under “Paediatric population”

Updated on 08 December 2016

Reasons for updating

  • Addition of joint SPC covering all presentations

Free text change information supplied by the pharmaceutical company

None provided

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

None provided