Braftovi 75 mg hard capsules
*Company:
Pierre Fabre 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 09 September 2024
File name
Braftovi_50mg_75mg_PIL_NI_IE_V9.0_NSCLC_clean_final_29.08.24.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- 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 09 September 2024
File name
Braftovi_50mg_75mg_SPC_NI_IE_V13_NSCLC_clean_final_29.08.24.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 March 2024
File name
Braftovi_50mg_75mg_SPC_NI_IE_V12_PRAC_clean_final_19.03.24.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 March 2024
File name
Braftovi_50mg_75mg_PIL_NI_IE_V8.0_PRAC_clean_final_19.03.24.pdf
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 December 2023
File name
Braftovi_50mg_75mg_hard capsule_SPC_UK(NI)_IE_V11_array_clean_14.12.23.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2023
File name
Braftovi_50mg_75mg_hard capsule_SPC_UK(NI)_IE_V10_renewal_final_clean_23.06.23.pdf
Reasons for updating
- Removal of Black Inverted Triangle
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2023
File name
Braftovi_50mg_75mg_hard capsule_SPC_UK(NI)_IE_V10_renewal_final_clean_23.06.23.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2023
File name
Braftovi_50mg_75mg_hard_capsule_PIL_UK(NI)_IE_V7.0_renewal_final_clean_23.06.23.pdf
Reasons for updating
- New PIL for new product
Updated on 28 July 2022
File name
Braftovi_50mg_75mg_hard capsule_SPC_UK(NI)_IE_V9_dose change_final_clean_25.07.22.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 28 July 2022
File name
Braftovi_50mg_75mg_hard_capsule_PIL_UK(NI)_IE_V6.0_dose change_final_clean_25.07.22.pdf
Reasons for updating
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
Update to How to take Braftovi
Updated on 07 February 2022
File name
Braftovi_50mg_75mg_hard capsule_SPC_UK(NI)_IE_V8_final aprroved_clean_24.01.22.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
Changes have been made to:
Section 7: Updated 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.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
Changes have been made to:
Section 6: Change of address of MA holder
Section 6: Updated revision date
Updated on 15 December 2021
File name
Braftovi_50mg_75mg_hard_capsule_SPC_IE_V7_20211014 clean DDI.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 highlighted ATC code.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.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.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
SmPC IE June 2020.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 11 June 2020
File name
PIL IE June 2020.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 18 July 2019
File name
Braftovi_50mg_75mg_hard_capsules_SPC_EN_V3.0_20190425 No header.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.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.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 24 October 2018
File name
Braftovi_50mg_75mg_hard_capsules_PIL_EN_V1.0_20180920 No Header.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 23 October 2018
File name
Braftovi_50mg_75mg_hard_capsules_SPC_EN_V1.0_20180920 No header.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.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 28 September 2018
File name
Braftovi_50mg_75mg_hard_capsules_PIL_EN_V1.0_20180920 No Header.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.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)