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HYCAMTIN 1mg and 4mg solution *

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Topotecan Hydrochloride

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

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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 14 September 2021

File name

REG_PIL_Hycamtin-IA-ATC+UK_NI_LYVI_IPHA_1631614981.pdf

Reasons for updating

  • Change to date of revision

Updated on 14 September 2021

File name

Hycamtin Solution_REG SPC_IPHA_Sep2021_1631607568.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 29 July 2021

File name

Hycamtin Solution_REG PIL_PF21-0181_07.06.2021_IPHA_1627557706.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 09 November 2020

File name

Hycamtin_solution_REG_SmPC_PF20-0243_IPHA_1604932351.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 09 November 2020

File name

Hycamtin Infusion_REG PIL_PF 19-0033_IPHA_1597317118.pdf

Reasons for updating

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

Updated on 13 August 2020

File name

Hycamtin Infusion_REG PIL_PF 19-0033_IPHA_1597317118.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer

Updated on 17 December 2019

File name

Hycamtin Infusion_REG PIL_PF 19-0033_IPHA_1576604162.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 28 March 2019

File name

Hycamtin_solution_REG_SmPC_PF18-0098_IPHA_1553790881.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 05 November 2018

File name

Hycamtin Lyvi_REG PIL_62000000029297_R91_IPHA_1541429810.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation number

Updated on 21 May 2018

File name

Hycamtin_solution_REG_SmPC_PF18-0098_Clean.docx

Reasons for updating

  • 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)

Updated on 29 January 2018

File name

PIL_9170_490.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 January 2018

Reasons for updating

  • Change to section 4 - possible side effects
  • Improved presentation of PIL

Updated on 10 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 11 October 2017

Reasons for updating

  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 25 May 2016

Reasons for updating

  • Change to marketing authorisation holder

Updated on 16 November 2015

Reasons for updating

  • Previous version of PIL reinstated

Updated on 06 October 2014

Reasons for updating

  • Addition of information on reporting a side effect.
  • Change to date of revision
  • Transfer of Marketing Authorisation Holder

Updated on 06 January 2014

Reasons for updating

  • Change to side-effects

Updated on 30 August 2013

Reasons for updating

  • Change of distributor details

Updated on 07 February 2011

Reasons for updating

  • Change to side-effects

Updated on 07 April 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to dosage and administration
  • Change to appearance of the medicine
  • Change to side-effects
  • Change to packaging

Updated on 21 August 2008

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 12 June 2008

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 04 April 2007

Reasons for updating

  • Change to side-effects

Updated on 04 August 2005

Reasons for updating

  • Improved electronic presentation

Updated on 28 October 2004

Reasons for updating

  • New PIL for medicines.ie