Jakavi Tablets

  • Name:

    Jakavi Tablets

  • Company:
    info
  • Active Ingredients:

    Ruxolitinib Phosphate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/11/19

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Summary of Product Characteristics last updated on medicines.ie: 10/7/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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1 - 0 of 116 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 28 November 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 10 July 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Update of section 4.5 based on final results from the DDI study INC4242A2106 (fluconazole/ruxolitinib)

Update of section 5.3 based on final results from the juvenile toxicity studies 1570143 (dose range finding juvenile study) and 157014 (juvenile development study)

 

Updated on 2 April 2019 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 23 August 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 5 June 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 7 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 February 2018 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 2 January 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

·         Section 4.8: Addition of “pneumonia” as a common ADR in MF patients.

Updated on 2 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 August 2017 PIL

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Removal of black triangle

Updated on 23 May 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Sepsis added as an ADR. Also SmPC updated with new data from RESPONSE and RESPONSE 2

Updated on 24 January 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Inclusion of 5 year data from COMFORT clinical trials

Updated on 11 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 29 November 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Section 4.4: A warning on opportunistic infections added to section 4.4

Section 4.4: Addition of information about increases in lipid parameters and a recommendation to monitor lipid levels and treat dyslipidaemia according to clinical guidelines.

Section 5.1: Addition of further clinical data for the RESPONSE trial

Updated on 14 September 2016 PIL

Reasons for updating

  • Deletion of a pack size

Updated on 9 August 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

The statement “Avoid the concomitant use of Jakavi with fluconazole doses greater than 200 mg daily” was added to SmPC Section 4.2 and 4.5. 

 

 

Updated on 21 July 2016 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Shelf life increased from 2 years to 3 years for tablets in blisters.
Bottle presentation deregistered.

Updated on 4 November 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 7 - Marketing authorisation holder
  • 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

In Section 4.4 reference has been made to non-melanoma skin cancers including basal cell, squamous cell and Merkel cell carcinomas.
The address of the MAH has been updated to Frimley from Horsham.
Date of revision of text has been updated to October 2015.

Updated on 14 April 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company



In Section 4.1 Therapeutic indications; Polycythaemia vera (PV) has been added as an indication.

 

In Section 4.2 Posology and method of administration; Information on dosing and Special Populations has changed reflecting the new indication (PV)

 

In section 4.8 Undesirable effects; section has been updated to include information on PV

In Section 5.1 Pharmacodynamic properties; Information has been updated

 

Updated on 23 January 2015 PIL

Reasons for updating

  • Introduction of new strength

Updated on 24 September 2014 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic 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 Section 5.1 for survival dta for 3 years.

Updated on 19 August 2014 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 December 2013 SmPC

Reasons for updating

  • Addition of black triangle
  • 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 6.5 - Nature and contents of container
  • 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 black triangle has been introduced to this SPC as it is subject to additional monitoring.
Section 4.8 includes details in relation to the reporting of side effects.
Blister strips have been introduced for this product in addition to bottles.

Updated on 26 August 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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 4.4 in relation to PML.

Updated on 19 April 2013 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided