Braftovi 50 mg hard capsules

  • Name:

    Braftovi 50 mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Encorafenib

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/06/20

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Summary of Product Characteristics last updated on medicines.ie: 11/6/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Pierre Fabre Limited

Pierre Fabre Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Braftovi 50 mg hard capsules Active Ingredients Encorafenib
Medicine Name Braftovi 75 mg hard capsules Active Ingredients Encorafenib
Medicine Name Busilvex 6 mg/ml concentrate for solution for infusion Active Ingredients Busulfan
Medicine Name Javlor 25 mg/ml concentrate for solution for infusion Active Ingredients Vinflunine Ditartrate
Medicine Name Mektovi 15 mg film-coated tablets Active Ingredients Binimetinib
Medicine Name Navelbine 20mg and 30mg Soft Capsules Active Ingredients Vinorelbine tartrate
Medicine Name Navelbine 20mg Soft Capsule Active Ingredients Vinorelbine tartrate
Medicine Name Navelbine 30mg Soft Capsule Active Ingredients Vinorelbine tartrate
Medicine Name Nerlynx 40 mg film-coated tablets Active Ingredients Neratinib Maleate
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When a pharmaceutical company changes any document, 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 11 June 2020 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • 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 6 - date of revision

Free text change information supplied by the pharmaceutical company

Major changes throughout the PIL following the addition of a new indication.

Updated on 11 June 2020

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

Free text change information supplied by the pharmaceutical company

Major changes throughout the SmPC following the addition of a new indication.

Updated on 18 July 2019

Reasons for updating

  • Change to section 6.3 - Shelf life

Updated on 25 February 2019 PIL

Reasons for updating

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

Updated on 25 February 2019

Reasons for updating

  • Change to section 8 - Marketing authorisation number(s)

Free text change information supplied by the pharmaceutical company

Addition of a new pack size, see details in 6.5 and 8.

Updated on 23 October 2018

Reasons for updating

  • New SmPC for medicines.ie

Updated on 23 October 2018

Reasons for updating

  • New SmPC for medicines.ie

Updated on 23 October 2018 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 October 2018

Reasons for updating

  • New SmPC for medicines.ie

Updated on 19 October 2018

Reasons for updating

  • New SmPC for medicines.ie

Updated on 28 September 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 September 2018

Reasons for updating

  • New SmPC for new product