Mekinist 0.5mg and 2mg 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 22 August 2024
File name
Mekinist_REG SPC PF24-0168_Aug2024_clean.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 19 August 2024
File name
Mekinist_REG SPC_PF24-0165_August_2024_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 19 August 2024
File name
Mekinist_REG PIL_PF24-0165_Aug_2024_clean_IPHA.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 16 August 2024
File name
Mekinist_REG SPC_PF24-0164_07.08.2024_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 07 June 2024
File name
Mekinist_REG SPC_PF24-0123_May2024_clean_IPHA.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 29 May 2024
File name
Mekinist_REG PIL_PF24-0110_May 2024_clean_IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 29 May 2024
File name
Mekinist_REG SPC_PF24-0110_May .2024_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
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
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
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
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
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
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
Updated on 06 January 2016
Reasons for updating
- New PIL for medicines.ie