Cabometyx Tablets

  • Name:

    Cabometyx Tablets

  • Company:
    info
  • Active Ingredients:

    Cabozantinib

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/11/20

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Summary of Product Characteristics last updated on medicines.ie: 17/6/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Ipsen Pharmaceuticals Ltd

Ipsen Pharmaceuticals Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Cabometyx Tablets Active Ingredients Cabozantinib
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Medicine Name Somatuline LA 30mg Active Ingredients Lanreotide acetate
Medicine Name Xermelo 250 mg film-coated tablets Active Ingredients Telotristat ethyl
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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 November 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

The following PIL section has been updated:

-Section 6: Addition of manufacturer Rottendorf Pharma GmbH

Updated on 17 June 2020 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

Changes have been made to the following sections of the PIL:

  • Section 5, to remove details of blister packaging
  • Section 6, to remove details of blister packaging

Updated on 17 June 2020

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

The following changes have been made to the SmPC:

  • Update of section 6.5 to remove details of blister packaging.
  • Update to section 8 to remove Marketing Authorisation Numbers associated with blister packaging

Updated on 27 May 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • 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

  • In section 2 Warnings and Precautions, a sentence was added regarding oral healthcare
  • In section 2 Interactions with other medicines, was updated to include medicines for the treatment of angina pectoris
  • In section 4 Possible side effects, a sentence was added regarding side effects related to osteonecrosis and additionally;
    • to remove Anaemia, Oral pain and Dry mouth from the list of adverse reactions (ADRs),
    • to add Dysphagia and Hyperkeratosis to the existing ADR, 
    • to replace Peripheral sensory neuropathy by Peripheral neuropathy in order to reflect the broader medical concept and to add DVT (Deep vein thrombosis) to the existing ADR venous thrombosis in order to alert prescribers to the most frequently reported type of venous thrombosis.
  • In section 6, update to name  and addresses of local affiliates 

Updated on 27 May 2020

Reasons for updating

  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

  • Update of section 4.2 to remove sentence regarding switching from capsule to tablet 
  • Update of section 4.4 of the SmPC to include the addition of the risk of Osteonecrosis.
  • Update of Section 4.8 of the SmPC based on the new version of the Company Core Safety Information (CCSI v4):
    • to remove Anaemia, Oral pain and Dry mouth from the list of adverse reactions (ADRs),
    • to add Dysphagia and Hyperkeratosis to the existing ADR, 
    • to replace Peripheral sensory neuropathy by Peripheral neuropathy in order to reflect the broader medical concept and to add DVT (Deep vein thrombosis) to the existing ADR venous thrombosis in order to alert prescribers to the most frequently reported type of venous thrombosis.
  • Changes to the frequency categorisation of some ADRs are also proposed based on new pooled data.
  • Update to section 5.1 to update Clinical efficacy and safety 

Updated on 11 November 2019

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

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

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

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

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

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

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

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 SPC

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 SPC

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

None provided

Updated on 14 September 2016 PIL

Reasons for updating

  • New PIL for new product