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: 05/11/19

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Summary of Product Characteristics last updated on medicines.ie: 11/11/2019
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
Medicine Name Decapeptyl (triptorelin) 3-month Active Ingredients triptorelin pamoate
Medicine Name Decapeptyl (triptorelin) SR Active Ingredients triptorelin acetate
Medicine Name Decapeptyl 6 Month 22.5mg Active Ingredients triptorelin pamoate
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Medicine Name Salvacyl 11.25 mg powder and solvent for prolonged-release suspension for injection Active Ingredients Triptorelin embonate
Medicine Name Somatuline Autogel 60 mg, 90 mg and 120 mg solution for injection in a pre-filled syringe Active Ingredients Lanreotide acetate
Medicine Name Somatuline LA 30mg Active Ingredients Lanreotide acetate
Medicine Name Xermelo 250 mg film-coated tablets Active Ingredients Telotristat ethyl
1 - 0 of 13 items.Total: Infinity pages

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

None provided

Updated on 14 September 2016 PIL

Reasons for updating

  • New PIL for new product