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Tafinlar 50mg and 75mg Hard Capsules

*
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):

    Dabrafenib Mesilate

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

  • Tafinlar 50-2.png
  • Tafinlar 75-2.png

Updated on 22 August 2024

File name

Tafinlar_REG SPC_PF24-0169_Aug_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
  • 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

Tafinlar_REG PIL_PF24-0162_AUG 2024_clean_IPHA.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 16 August 2024

File name

Tafinlar_REG SPC_PF24-0162_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

REG SPC_Tafinlar_PF24-0099_PF24_0123_May2024_clean_IPHA.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 07 June 2024

File name

REG SPC_Tafinlar_PF24_0087_PF24-0099_PF24_0123_May2024_clean_IPHA.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • 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 07 June 2024

File name

Tafinlar_REG PIL_PF24-0099_PF24_0087-clean_May2024_IPHA.pdf

Reasons for updating

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

Updated on 29 May 2024

File name

Tafinlar_REG PIL_PF24-0087_April 2024_clean_IPHA.pdf

Reasons for updating

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

Updated on 29 May 2024

File name

Tafinlar_REG SPC_PF24_0087_April_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 29 May 2024

File name

Tafinlar_REG PIL_PF24-0087_May 2024_clean_IPHA.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications

Updated on 15 March 2024

File name

Tafinlar_REG PIL_PF24-0054_IPHA March2024.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company



Updated on 14 March 2024

File name

Tafinlar_REG SPC_PF24-0054_March 2024_clean_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 02 March 2023

File name

Tafinlar_REG SPC_PF23-0054_Feb2023_IPHA_clean.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

Tafinlar_REG PIL_PF23-0054_Feb2023_IPHA.pdf

Reasons for updating

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

Updated on 10 December 2021

File name

Tafinlar_REGSPC_Nov2021_Clean_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 01 September 2021

File name

Tafinlar_REGPIL_IPHA_Aug2021.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 31 August 2021

File name

Tafinlar_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

Tafinlar_REG SPC_PF21-0180_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 14 January 2021

File name

Tafinlar_REG SPC_PF21-0010_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 14 January 2021

File name

Tafinlar_REG PIL_PF21-0010_IPHA-Jan2021.pdf

Reasons for updating

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

Updated on 14 January 2021

File name

Tafinlar_REG PIL_PF20_0278_Dec2020_IPHA.pdf

Reasons for updating

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

Updated on 05 January 2021

File name

Tafinlar_REG PIL_PF20_0278_Dec2020_IPHA.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 28 November 2019

File name

Tafinlar 50mg_75mg_REG SmPC_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_Tafinlar_PF19-0109_IPHA.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects

Updated on 03 July 2019

File name

Tafinlar_50mg_75mg_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 06 June 2019

File name

Tafinlar_50mg_75mg_REG SPC_PF 19-0091_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 10 - Date of revision of the text

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

Updated on 28 March 2019

File name

Tafinlar_50mg_75mg_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
  • Change to section 6.3 - Shelf life

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

Updated on 25 October 2018

File name

Tafinlar REG PIL6030_R212_IPHA.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 06 September 2018

File name

Tafinlar_50mg and 75mg hard capsules_REG SPC_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 4.6 - Pregnancy and lactation
  • 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 12 July 2018

File name

Tafinlar_50mg and 75mg hard capsules_REG SPC_PF 18-0196_clean.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Updated on 04 July 2018

File name

Tafinlar REG PIL5317_R212_IPHA.pdf

Reasons for updating

  • Previous version of PIL reinstated

Updated on 11 June 2018

File name

Tafinlar_50mg and 75mg hard capsules_REG SPC_Renewal_Clean.docx

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

Document updated to bring it in line with QRD template.

Updated on 01 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 01 March 2018

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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)

Free text change information supplied by the pharmaceutical company

Section 5.1 updated to include the following:

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.
Section 5.2 updated to update the in vitro evaluation of drug interaction potential information for BCRP and OCT transporters located in section 5.2 based on the conclusions of study reports 2014N220059 and reports 2015N235499.

Updated on 09 November 2017

Reasons for updating

  • 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 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)

Free text change information supplied by the pharmaceutical company

Section 4.4 updated to remove the statement "agents that increase gastric pH might decrease the bioavailability of dabrafenib and should be avoided when possible".
Sections 4.4, 4.5 and 5.2 revised to include the results of a drug-drug interaction between dabrafenib and rosuvastatin (an OATP1B1/1B3 substrate) and between dabrafenib and midazolam (a CYP3A4 substrate) based on study 200919.

Updated on 30 August 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Update of section 4.5 in order to include warning on a drug-drug interaction between dabrafenib and rifampicin (a CYP3A4/CYP2C8 inducer) and between dabrafenib and rabeprazole (a pH elevating agent).

Updated on 12 July 2017

File name

PIL_15835_505.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 July 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 15 June 2017

Reasons for updating

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

Update to section 4.4 of the SmPC to add a new warning on colitis and gastrointestinal perforation.
Update of section 4.8 of the SmPC to include as new adverse drug reactions ‘photosensitivity reaction’ with a ‘common’ frequency, ‘colitis’ and ‘gastrointestinal perforation’ with a ‘common’ frequency and ‘myocarditis’ with a ‘not known’ frequency.

Updated on 05 April 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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

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 following approval of new indication:

Non-small cell lung cancer (NSCLC)

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

Updated on 14 September 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 29 June 2016

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 4.8 – Undesirable effects - how to report a side effect
  • 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

Sections 4.2, 4.4 and 4.8 have been updated to delete text related to QT prolongation.
Section 5.1 has been revised to include a paragraph on QT prolongation.

Updated on 18 May 2016

Reasons for updating

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

Section 4.8 revised to include bradycardia and "heart rate decreased" as side effects.
Editorial changes made to bring document in line with QRD template.
Combined SmPC for both strengths of hard capsules.

Updated on 10 December 2015

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • 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 5.3 has been updated as follows:

In juvenile toxicity studies in rats, effects on growth (shorter long bone length), renal toxicity (tubular deposits, increased incidence of cortical cysts and tubular basophilia and reversible increases in urea and/or creatinine concentrations) and testicular toxicity (degeneration and tubular dilation) were observed (≥ 0.2 times adult human clinical exposure based on AUC). Dabrafenib was phototoxic in an in vitro mouse fibroblast 3T3 Neutral Red Uptake (NRU) assay and in vivo at doses ≥ 100 mg/kg (> 44 times clinical exposure based on Cmax) in an oral phototoxicity study in hairless mice.

Updated on 19 October 2015

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 - reclassification of panniculitis system organ class from immune system disorder to skin and subcutaneous tissue disorder.

Updated on 09 September 2015

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

SmPC revised to include new indication for Tafinlar in combination with trametinib (TAF+MEK).

Updated on 05 December 2014

Reasons for updating

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

Updated on 04 September 2014

Reasons for updating

  • Change to further information section

Updated on 06 August 2014

Reasons for updating

  • Change to drug interactions
  • Addition of information on reporting a side effect.

Updated on 15 May 2014

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details

Updated on 27 February 2014

Reasons for updating

  • Improved electronic presentation

Updated on 06 September 2013

Reasons for updating

  • New PIL for new product