Braftovi 50 mg hard capsules
- Name:
Braftovi 50 mg hard capsules
- Company:
Pierre Fabre Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/01/21
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Pierre Fabre Limited
Company Products
| Medicine Name | Active 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 |
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 SPC
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 PIL
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 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 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 25 February 2019 SPC
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 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 22 October 2018 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 28 September 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)