Tafinlar 50mg and 75mg Hard Capsules
*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 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
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
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
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
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
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
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
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
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