Login

Xalkori 200mg and 250 mg hard capsules

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Crizotinib

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

Updated on 02 November 2022

File name

AdvPILXI360IENIclean.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 2 - use in children and adolescents
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 02 November 2022

File name

AdvSPCXI350IEclean.pdf

Reasons for updating

  • 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 4.8 - 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)

Updated on 27 June 2022

File name

AdvSPC XI 34_0 IE clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Updated on 27 June 2022

File name

Adv PIL XI 35_0 IE NI clean.pdf

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

Updated on 22 February 2022

File name

AdvSPCXI330IEclean.pdf

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

The SPC has been updated as follows: Section 5.1 ATC code has been updated in line with WHO updates to ATC/DDD index to L01ED01.

Updated on 16 February 2022

File name

AdvSPCXI330IEclean.pdf

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

The SPC has been updated as follows: Section 5.1 ATC code has been updated in line with WHO updates to ATC/DDD index to L01ED01.

Updated on 29 October 2021

File name

Adv PIL XI 34_0 IE NI clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section
  • Individual PILs superseded by joint PIL

Updated on 21 July 2021

File name

DEC202149245_Adv SPC XI 32_0 IE clean.pdf

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 4.6 - Pregnancy and lactation
  • 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 6.5 - Nature and contents of container

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

Updated on 21 July 2021

File name

DEC202149245_Adv PIL XI 33_0 IE clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 07 October 2020

File name

DEC202066574_ADV SPC XI 31_0 IE 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 07 October 2020

File name

DEC202066574_ADV SPC XI 31_0 UK 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 07 October 2020

File name

DEC202066574_ADV PIL XI 32_0 IE clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 12 December 2019

File name

DEC201969412_ADV SPC XI 30_0 IE_clean.pdf

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

The SPC has been updated as follows:

Section 5.1 updated to include data on ROSI-postitive NSCLC

SmPC updated to QRD tempate 10.1

Updated on 12 December 2019

File name

DEC201969412_ADV PIL XI 30_0 UK IE-clean.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 15 November 2019

File name

DEC201964072_ADV PIL XI 29_0 UK IE-clean.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 04 March 2019

File name

ADV PIL XI 27_0 UK IE clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 04 March 2019

File name

ADV SPC XI 29_0 IE clean.pdf

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

The SPC has been updated as follows: Removal of black triangle and additional monitoring statement

Updated on 19 February 2018

File name

PIL_15568_650.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 February 2018

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 19 January 2018

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • 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 15 August 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 15 November 2016

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 05 September 2016

Reasons for updating

  • Change to, or new use for medicine

Updated on 08 August 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 03 August 2016

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 23 June 2016

Reasons for updating

  • Change to MA holder contact details

Updated on 31 May 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to warnings or special precautions for use

Updated on 26 November 2015

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects

Updated on 17 November 2015

Reasons for updating

  • Change to date of revision

Updated on 22 May 2015

Reasons for updating

  • Change to date of revision
  • Change of distributor details

Updated on 19 February 2015

Reasons for updating

  • Change to date of revision

Updated on 03 September 2014

Reasons for updating

  • Change to date of revision

Updated on 28 August 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 19 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 26 March 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 03 February 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 27 November 2013

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 23 July 2013

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 24 May 2013

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change of distributor details

Updated on 30 November 2012

Reasons for updating

  • New PIL for new product