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

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 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  • Individual PILs superseded by joint PIL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