Cabometyx Tablets
- Name:
Cabometyx Tablets
- Company:
Ipsen Pharmaceuticals Ltd
- 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: 05/11/19
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Ipsen Pharmaceuticals Ltd
Company Products
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 November 2019 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Correction to table in section 4.8 to reinstate AEs.
Updated on 5 November 2019 PIL
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
Free text change information supplied by the pharmaceutical company
Type IAin variation to update sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of the PIL to implement the recommendation of the PRAC further to artery dissections and aneurysms signal on Vascular Endothelial Growth Factor (VEGF) inhibitors for systemic administration
Updated on 5 November 2019 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
Type IAin variation to update sections 4.4 and 4.8 of the SmPC and sections 2 and 4 of the PIL to implement the recommendation of the PRAC further to artery dissections and aneurysms signal on Vascular Endothelial Growth Factor (VEGF) inhibitors for systemic administration
Updated on 27 August 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 16 November 2018 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 16 November 2018 SmPC
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 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 sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 10 due to additon of new indication for the treatment of hepatocellular carcinoma
Updated on 3 September 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 3 September 2018 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to section 4.8 to include additional adverse events after review of PSUR for cabozantinib.
Updated on 22 June 2018 PIL
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 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 June 2018 SmPC
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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to SmPC to include indication for treatment for 1st line RCC patients.
Updated on 15 November 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 November 2017 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic 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
Update to Sections 4.5, 5.1 and 5.3:
Section 4.5: addition of interaction between warfarin and cabozantanib
Sections 5.1 and 5.3: additional data on OS for patients
Updated on 14 November 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 14 November 2017 PIL
Reasons for updating
- Change to other sources of information section
Updated on 18 October 2016 SmPC
Reasons for updating
- Addition of joint SPC covering all presentations
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 14 September 2016 PIL
Reasons for updating
- New PIL for new product