Braftovi 75 mg hard capsules

Product Information *

  • Company:

    Pierre Fabre Limited
  • Status:

    No Recent Update
  • Active Ingredients * :

    This medicinal product is subject to additional monitoring.

    *Additional information is available upon request

  • Legal Category:

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

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 19 January 2021

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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

The update reflects the change to the immediate packaging (blister) of the finished product from a “push-through” polyamide / aluminium / PVC / aluminium blisters to “peelable” polyamide / aluminium / PVC / aluminium / PET / paper perforated unit dose and the date that this was approved.

Please see sections 6.5 and 8.

Updated on 19 January 2021

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The update reflects the change to the immediate packaging (blister) of the finished product from a “push-through” polyamide / aluminium / PVC / aluminium blisters to “peelable” polyamide / aluminium / PVC / aluminium / PET / paper perforated unit dose and the date that this was approved.

Please see sections 3 and 6.

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

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

Free text change information supplied by the pharmaceutical company

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

Updated on 11 June 2020

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 18 July 2019

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 25 February 2019

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)

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

Free text change information supplied by the pharmaceutical company

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

Updated on 24 October 2018

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 October 2018

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 23 October 2018

Reasons for updating

  • New PIL for medicines.ie

Updated on 28 September 2018

Reasons for updating

  • New PIL for new product

Updated on 28 September 2018

Reasons for updating

  • New SPC for new product

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