Braftovi 50 mg hard capsules *
Pharmacy Only: Prescription

  • Company:

    Pierre Fabre Limited
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

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

Updated on 28 July 2022

File name

62e25807e875b.pdf

Reasons for updating

  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

Update of How to take Braftovi

Updated on 28 July 2022

File name

62e2576543acd.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 the 2nd dose reduction for encorafenib when used in combination with binimetinib in melanoma indication.

Updated on 07 February 2022

File name

Braftovi_50mg_75mg_hard capsule_SPC_UK(NI)_IE_V8_final aprroved_clean_24.01.22_1644249198.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Section 7: Change of MA holder address

Section 10: Updated revision date

Updated on 07 February 2022

File name

Braftovi_50mg_75mg_hard_capsule_PIL_UK(NI)_IE_V5.0_final approved_24.01.22_1644248876.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

Section 6 Change of MA Holder address

Section 6 Updated revision date

Updated on 15 December 2021

File name

Braftovi_50mg_75mg_hard_capsule_SPC_IE_V7_20211014 clean DDI_1639589344.pdf

Reasons for updating

  • 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 4.5 and 5.2 of the SmPC have been updated to reflect the results of a drug-drug interaction study concerning rosuvastatin and bupropion.

Section 10 was updated to reflect the date of approval of this submission.

Updated on 19 August 2021

File name

Braftovi_50mg_75mg_hard_capsule_SPC_IE_V6 clean ATC code_1629368923.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)

Free text change information supplied by the pharmaceutical company

The ATC Code was updated in Section 5.1, Pharmacodynamic Properties.

Section 10, Date of Revision of the Text was updated to reflect the approval of this change.

Updated on 19 January 2021

File name

Braftovi_50mg_75mg_hard_capsule_SPC_IE_V5.0_20210113_1611068510.pdf

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

File name

Braftovi_50mg_75mg_hard_capsule_PIL_IE_V4.0_20210113_1611068123.pdf

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

File name

PIL IE June 2020_1591866935.pdf

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

File name

SmPC IE June 2020_1591866615.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 4.5 - 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 18 July 2019

File name

Braftovi_50mg_75mg_hard_capsules_SPC_EN_V3.0_20190425 No header_1563454843.pdf

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

File name

Braftovi_50mg_75mg_hard_capsules_PIL_EN_V2.0_20181030 No Header_1551104218.pdf

Reasons for updating

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

Updated on 25 February 2019

File name

Braftovi_50mg_75mg_hard_capsules_SPC_EN_V2.0_20181107 No header_1551104461.pdf

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 23 October 2018

File name

Braftovi_50mg_75mg_hard_capsules_SPC_EN_V1.0_20180920 No header_1540312770.pdf

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

File name

Braftovi_50mg_75mg_hard_capsules_SPC_EN_V1.0_20180920 No header_1540312162.pdf

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

File name

Braftovi_50mg_75mg_hard_capsules_PIL_EN_V1.0_20180920 No Header_1538133390.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 October 2018

File name

Braftovi_50mg_75mg_hard_capsules_SPC_EN_V1.0_20180920 No header_1540197686.pdf

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 19 October 2018

File name

Braftovi_50mg_75mg_hard_capsules_SPC_EN_V1.0_20180920 No header_1539948639.pdf

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 28 September 2018

File name

Braftovi_50mg_75mg_hard_capsules_PIL_EN_V1.0_20180920 No Header_1538133390.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 September 2018

File name

Braftovi_50mg_75mg_hard_capsules_SPC_EN_V1.0_20180920 No header_1538133440.pdf

Reasons for updating

  • New SPC for new product

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