Cisplatin *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

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

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 15 October 2021

File name

Reg SPC gxCP 9_4 IE_clean_1634302227.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • 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 20 April 2021

File name

DEC202126414_Reg SPC gxCP 7_2 IE_clean_1618898665.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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:

Section 2 – Excipient update regarding sodium

Section 4.4 – Update concerning excipient information for sodium

Section 4.8 – Update to AE Reporting Details

Section 10 – revised date of revision

 

Updated on 20 April 2021

File name

DEC202126414_Reg PIL gxCP 9_1 IE_clean_1618898540.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 03 February 2021

File name

DEC202107384_Reg PIL gxCP 7_2 IE_clean_1612350008.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 12 March 2019

File name

DEC201912364_Reg PIL gxCP 6_1 IE_clean_1552402890.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 12 March 2019

File name

DEC201912364_Reg SPC gxCP 5_1 IE_clean_1552402960.pdf

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)

Updated on 02 November 2018

File name

Reg PIL gxCP 5_0 IE_clean_1541147273.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 - what you need to know - contraindications
  • 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 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents

Updated on 01 November 2018

File name

Reg PIL gxCP 5_0 IE_clean_1541089714.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 - what you need to know - contraindications
  • 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 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents

Updated on 01 November 2018

File name

Reg SPC gxCP 4_0 IE_clean_1541089958.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 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

SPC sections 2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 6.3, 6.5, and 6.6 – updated in line with QRD v10 Template, Date revised in section 10.

Updated on 23 October 2018

File name

Reg PIL gxCP 4_0 IE_clean_1540300040.pdf

Reasons for updating

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

Updated on 01 October 2018

File name

Reg SPC gxCP 3_0 IE_clean_1538389744.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 28 September 2018

File name

Reg PIL gxCP 3_0 IE_clean_1538064885.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 27 September 2018

File name

Reg SPC gxCP 3_0 IE_clean_1538064808.pdf

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

The SPC has been updated as follows: Section 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number

Updated on 08 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 02 August 2017

File name

PIL_17240_552.pdf

Reasons for updating

  • New PIL for new product