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Novartis Ireland Limited

Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, Ireland
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 15/06/2017
SPC Tafinlar 50mg and 75mg Hard Capsules

When a pharmaceutical company changes an SPC or PIL, 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 15/06/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   30-May-2017
Legal Category:   Product subject to restricted prescription (C)

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 05/04/2017 and displayed until 15/06/2017
Reasons for adding or 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
Date of revision of text on the SPC:   29-Mar-2017
Legal Category:   Product subject to restricted prescription (C)

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 29/06/2016 and displayed until 05/04/2017
Reasons for adding or 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
Date of revision of text on the SPC:   23-Jun-2016
Legal Category:   Product subject to restricted prescription (C)

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 18/05/2016 and displayed until 29/06/2016
Reasons for adding or 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
Date of revision of text on the SPC:   02-May-2016
Legal Category:   Product subject to restricted prescription (C)

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 10/12/2015 and displayed until 18/05/2016
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Oct-2015
Legal Category:   Product subject to restricted prescription (C)

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 19/10/2015 and displayed until 10/12/2015
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   24-Sep-2015
Legal Category:   Product subject to restricted prescription (C)

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 09/09/2015 and displayed until 19/10/2015
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

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

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Active Ingredients

 
   Dabrafenib mesilate