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Revolade 25 mg and 50mg film-coated tablets

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Eltrombopag Olamine

    *Additional information is available within the SPC or upon request to the company

  • Revolade 25-2.png
  • Revolade 50-2.png

Updated on 29 June 2023

File name

Revolade_REG SPC_PF23-0092_June2023_clean_IPHA.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 24 October 2022

File name

Revolade_REG SPC_PF22-0203_Oct2022_IPHA_clean.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 10 January 2022

File name

Proposed PIL_Revolade_IPHA_PF21-0325_Dec2021.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 13 September 2021

File name

REGPIL_IPHA_RevoladeFCTs_September2021.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 02 March 2021

File name

RevoladeFCT_REGPIL_IPHA_Jan2021clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 02 March 2021

File name

Revolade_REG SPC PF IPHA_Jan_2021.pdf

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)

Updated on 04 August 2020

File name

Revolade REG SPC PF 20-0150 August 2020 Clean IPHA.pdf

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 26 February 2020

File name

Revolade FCT_REG PIL_PF 20-0039_IPHA.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 05 December 2019

File name

Revolade_FCT REG PIL_PF 18-0252_IPHA.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 26 March 2019

File name

Revolade FCT REG PIL_1138932_A19_R89_IPHA.pdf

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 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 28 February 2019

File name

Revolade_FCT_REG SmPC_PF 18-0130_clean.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

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

Updated on 28 November 2018

File name

Revolade FCT REG PIL_1138932_B18_R89_IPHA.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 02 August 2018

File name

PIL_14637_37.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 July 2018

File name

Revolade_FCTab_REGSmPC_PF 18-0022_clean.pdf

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)

Updated on 21 May 2018

File name

Revolade_FCTab_REGSmPC_PF 18-0021_clean.docx

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 10 May 2018

Reasons for updating

  • New SPC for new product

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

Updated on 27 February 2017

File name

PIL_14637_37.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 February 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 30 January 2017

Reasons for updating

  • New SPC for new product

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

Updated on 30 January 2017

Reasons for updating

  • 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

Section 4.8 revised to include ADR "skin discolouration" with frequency "not known"

Updated on 16 November 2016

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

Sections 4.4 and 4.8 have been updated to include information relating to drug-induced livery injury.

Updated on 03 August 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to dosage and administration

Updated on 29 June 2016

Reasons for updating

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

Section 4.8 updated to replace "one" with "a small number of" in the section on Increased bone marrow reticulin

Section 5.1 updated to include data from 2 clinical trials.

Updated on 25 May 2016

Reasons for updating

  • Change to side-effects
  • Change to marketing authorisation holder

Updated on 13 April 2016

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 - 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 6.1 - List of excipients
  • Change to section 8 - MA number
  • 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

SmPC updated with details of new paediatric indication: “Revolade is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients aged 1 year and above who are refractory to other treatments (e.g. corticosteroids, immunoglobulins)”.
The corresponding sections of the SmPC have been revised accordingly.

Updated on 10 February 2016

Reasons for updating

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

Section 4.1 updated to include non-splenectomised adult patients.
Section 4.2 updated to include information about non-splenectomised patients.
Section 5.1 updated to include the following statement: Clinical studies comparing eltrombopag to other treatment options (e.g. splenectomy) have not been conducted. The long-term safety of eltrombopag should be considered prior to starting therapy.

Updated on 04 November 2015

Reasons for updating

  • 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

Section 4.8 of the SmPC revised in order to include gingivitis, skin infection and mouth ulceration as new adverse reactions

Updated on 07 September 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 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

SmPC updated to include new indication "Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation.”

Updated on 02 June 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

7.       MARKETING AUTHORISATION HOLDER

Updated on 04 February 2015

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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 9 - Date of renewal of authorisation
  • 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

Description of change to SPC:

Section 4.2 – Administrative updates

Section 4.4 – Administrative updates and removal of sodium-free statement

Section 4.5 – Reordering of existing information

Section 4.7 -  to align with the artwork. No content change
Section 4.8 – Updates based on latest pooled analysis of AEs/ADRs for ITP-controlled trials. Plus IMB to HPRA update

Sections 5.1, 5.2 and 5.3 – Minor administrative updates

Section 9 – Addition of first renewal date

Section 10 – updated text approval date

Updated on 30 January 2015

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 03 June 2014

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Section 4.5 Interactions - Updated the DDI statements.

Updated on 02 June 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 19 May 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.8 = ADR reporting addresses added

Section 7  = MAH address updated

Updated on 16 May 2014

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details
  • Addition of information on reporting a side effect.
  • Improved electronic presentation

Updated on 08 November 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

Changes to:

 

 

Section 4.1 -Therapeutic indications, Section 4.2 - Posology and method of administration, Section 4.4 - Special warnings and precautions for use, Section 4.5 - Interaction with other medicinal products and other forms of interaction, Section 4.6 - Pregnancy and lactation, Section 4.8 - Undesirable effects, Section 5.1 - Pharmacodynamic properties, Section 5.2 - Pharmacokinetic properties, Section 5.3 - Preclinical safety data

 

Updated on 31 October 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to dosage and administration

Updated on 10 July 2013

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 04 October 2011

Reasons for updating

  • Change of manufacturer

Updated on 12 April 2010

Reasons for updating

  • New PIL for new product
  • New PIL for medicines.ie