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Mekinist 0.5mg and 2mg film-coated tablets

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Trametinib Dimethyl Sulfoxide

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

  • Mekinist 2-2.png

Updated on 22 March 2024

File name

Mekinist REG SPC_PF24-0062_March2024_IPHA.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 22 March 2024

File name

Mekinist REG PIL_PF24-0062_March 2024_clean_IPHA.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 15 March 2024

File name

Mekinist_REG PIL_PF24-0055_March 2024_clean_IPHA.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 14 March 2024

File name

Mekinist_REG PIL_PF24-0055_March 2024_clean_IPHA.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 14 March 2024

File name

Mekinist_REG SPC_PF24-0055_March2024_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 02 March 2023

File name

Mekinist_REG SPC_PF23-0194_24.02.2023_clean_IPHA.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 02 March 2023

File name

Mekinist REG_PIL_PF23-0194_Feb 2023_IPHA.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 15 August 2022

File name

Mekinist_REG SPC_PF22-0141_July_2022_clean_IPHA.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 02 August 2022

File name

Mekinist_REG PIL_PF22-0141_July_2022_clean_IPHA.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 02 August 2022

File name

Mekinist_REG PIL_PF22-0141_July_2022_clean_IPHA.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 05 May 2022

File name

Mekinist_REG SPC_PF22-0095_IPHA_April_2022.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 10 December 2021

File name

Mekinist_REG SPC_IPHA_Nov2021.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 18 October 2021

File name

Mekinist_SPC_IPHA_Oct2021.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 18 October 2021

File name

Mekinist_PIL_IPHA_Oct2021.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 01 September 2021

File name

Mekinist_REG PIL_IPHA_August2021.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects

Updated on 31 August 2021

File name

Mekinist_REG SPC_PF21-0220_26.08.2021_clean.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 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 29 July 2021

File name

Mekinist_REG SPC_PF21-0179_June2021_IPHA.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 05 March 2021

File name

Mekinist REGPIL_IPHA_ PF21-0039_Jan2021.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 04 March 2021

File name

MekinstREG REG SPC_IPHA_PF21-0039_Jan2021.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 February 2021

File name

Mekinist_REG SPC_IPHA_Jan2021.pdf

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)

Updated on 15 January 2021

File name

Mekinist_REG PIL_IPHA_Jan2021.pdf

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)

Updated on 15 January 2021

File name

Mekinist_REG PIL_IPHA_Jan2021.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 17 September 2020

File name

Mekinist 0.5mg_2mg REG PIL PF20-0149 IPHA.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer

Updated on 31 July 2020

File name

Mekinist REG PIL PF20-0149July2020 IPHA.pdf

Reasons for updating

  • Change to name of manufacturer

Updated on 28 November 2019

File name

Mekinist_0.5_2mg_REG SmPC_PF 19-0215_IPHA.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 18 July 2019

File name

REG PIL_Mekinist_PF19-0109_IPHA.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects

Updated on 03 July 2019

File name

Mekinist_0.5mg_2mg_REG SPC_PF 19-0109_IPHA.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 May 2019

File name

Mekinist REG PIL_46246817_R89_IPHA.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Removal of Black Inverted Triangle

Updated on 28 March 2019

File name

Mekinist_0.5mg_2mg_REG SPC_PF 19-0067_IPHA.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 25 February 2019

File name

Mekinist_0.5mg_2mg_REG SPC_Renewal_IPHA.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 December 2018

File name

Mekinist REG PIL_46235424_R89_IPHA.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 06 September 2018

File name

Mekinist_0.5mg_2mg_REG SmPC_PF 17-0142_IPHA.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 4.8 - 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 04 July 2018

File name

Mekinist REG PIL1669_R212_IPHA.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 12 June 2018

File name

Mekinist_0.5mg_2mg_REGSPC_MAT_clean.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 28 February 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 28 February 2018

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)

Free text change information supplied by the pharmaceutical company

Section 5.1 updated to add the following statements:

An updated OS analysis (15 February 2016) demonstrated an improvement in OS for the combination compared with dabrafenib monotherapy. The 3-year OS estimate for the combination arm was greater than for dabrafenib monotherapy (44% versus 32%, respectively). The median OS for the combination arm was approximately 8 months longer than the median OS for dabrafenib monotherapy (26.7 months versus 18.7 months). These data also demonstrated a reduction in the risk of death (HR=0.75, 95% CI: 0.58, 0.96) which was consistent with the primary OS analysis.

 

An updated OS analysis (15 July 2016) demonstrated improvement in OS for the combination compared with vemurafenib monotherapy. The 3-year OS estimate was 45% for combination therapy and 31% for vemurafenib. The median OS for the combination arm was approximately 8 months longer than the median OS for vemurafenib monotherapy (26.1 months versus 17.8 months). These data also demonstrated a reduction in the risk of death (HR=0.68, 95% CI: 0.56, 0.83) which was consistent with the primary OS analysis.

Updated on 27 February 2018

File name

PIL_16590_541.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 February 2018

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 26 October 2017

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)

Free text change information supplied by the pharmaceutical company

Section 6.3 revised to extend shelf life from 18 to 24 months.

Updated on 30 August 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 has been updated to add the adverse reaction ‘photosensitivity reaction’ with a frequency ‘common’ for the trametinib/dabrafenib combination therapy.

Updated on 19 June 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 05 April 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to SmPC due to approval of new indication:

Non-small cell lung cancer (NSCLC)

Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.

Updated on 19 October 2016

Reasons for updating

  • Change to section 4 - possible side effects
  • Discontinuation of one or more strengths

Updated on 31 August 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 updated to include the following statement:

In patients receiving trametinib in combination with dabrafenib, there have been occasional reports of acute, severe left ventricular dysfunction due to myocarditis. Full recovery was observed when stopping treatment. Physicians should be alert to the possibility of myocarditis in patients who develop new or worsening cardiac signs or symptoms.
Section 4.8 revised to add the adverse reaction myocarditis with a frequency unknown for trametinib and dabrafenib combination therapy.

Updated on 24 August 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 13 April 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

Updated on 06 January 2016

Reasons for updating

  • New PIL for medicines.ie