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Xalkori 200mg and 250 mg hard capsules

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland Unlimited Company

  • 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 18 November 2024

File name

Adv SPC XI 38_0 IE clean.pdf

Reasons for updating

  • Improved presentation of SPC

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

Updated on 15 November 2024

File name

Adv PIL XI 38_0 IE NI clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 13 November 2024

File name

Adv SPC XI 37_0 IE clean.pdf

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

The SPC IE has been updated as follows: section 6.4 has been updated to include storage conditions.

Updated on 27 August 2024

File name

Adv SPC XI 36_1 IE clean.pdf

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 4.4 - 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 5.1 - 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 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • 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 SPC has been updated as follows:  Indication Modification to expand the lower age range of the paediatric indications from 6 years to 1 years old, and Line Extension for the granules in capsules for opening formulation. Sections 1, 2, 3, 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2, 5.3, 6.1, 6.3, 6.5, 6.6, 8, 10 are updated.

Updated on 27 August 2024

File name

Adv PIL XI 37_1 IE NI clean.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

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