Zirabev 25 mg/ml concentrate for solution for infusion *
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):

    This medicinal product is subject to additional monitoring.

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

Updated on 04 August 2022

File name

62ebe378f2152.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 04 August 2022

File name

62ebe32a9c37c.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 20 May 2022

File name

6287750814b5d.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 10 November 2021

File name

Adv PIL bZR 8_0 IE & NI - clean_1636553845.pdf

Reasons for updating

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  • Individual PILs superseded by joint PIL

Updated on 17 May 2021

File name

DEC202132615_Adv PIL bZR 7_0 IE - clean_1621234543.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 17 May 2021

File name

DEC202132615_Adv SPC bZR 8_1 IE - clean_1621233800.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • 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: update in line with Innovator, section 4.4 (traceability) and section 5.1 (soft tissue sarcoma; overall survival analyses); date of revision.

Updated on 09 December 2020

File name

DEC202082509_Adv SPC bZR 7_0 IE - clean_1607514025.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 09 December 2020

File name

DEC202082509_Adv PIL bZR 6_0 IE - clean_1607513920.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - date of revision

Updated on 03 November 2020

File name

DEC202073610_Adv SPC bZR 6_1 IE - CLEAN_1604427457.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 03 November 2020

File name

DEC202073610_Adv PIL bZR 5_1 IE - CLEAN_1604427342.pdf

Reasons for updating

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

Updated on 15 October 2020

File name

DEC202065304_Adv SPC bZR 5_0 IE - clean_1602775041.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - 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 - how to report a side effect
  • 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 6.6 - Special precautions for disposal and other handling

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

Updated on 02 October 2020

File name

DEC202065304_Adv SPC bZR 5_0 IE - clean_1601636262.

Reasons for updating

  • 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 - how to report a side effect
  • 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 6.6 - Special precautions for disposal and other handling

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

Updated on 02 October 2020

File name

DEC202065304_Adv SPC bZR 5_0 IE - clean_1601636261.

Reasons for updating

  • 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 - how to report a side effect
  • 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 6.6 - Special precautions for disposal and other handling

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

Updated on 02 October 2020

File name

DEC202065304_Adv SPC bZR 5_0 IE - clean_1601633944.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Updated on 02 October 2020

File name

DEC202065304_Adv PIL bZR 4_0 IE - clean_1601633828.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 29 July 2020

File name

DEC202050241_Adv SPC bZR 4_1 UK IE_1596013481.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 29 July 2020

File name

DEC202050241_Adv PIL bZR 3_1 IE_1596013459.pdf

Reasons for updating

  • New PIL for new product