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HYCAMTIN 1mg and 4mg solution *
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):

    Topotecan Hydrochloride

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

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