Zirabev 25 mg/ml concentrate for solution for infusion
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal 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
Updated on 25 July 2025
File name
Clean Adv PIL bZR 15_0 IE .pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC changes.
Updated on 25 July 2025
File name
Clean Adv SPC bZR 14_0 IE.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 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
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 to add polysorbate 80 as excipient as well as its quantity in section 2 , 4.4, 6.1 and minor update in section 5.1.
Updated on 13 June 2025
File name
Clean Adv SPC bZR 13_0 IE .pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- Updated inline with QRD template and/or excipient guideline
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:
- Incorporate minor editorial changes to align with the Avastin (Roche) EU reference label . The changes are primarily minor editorial updates to wording (e.g., spelling, grammar, use of capitalization/hyphenation, minor rewording) and formatting of numbers, ranges, units of measure and storage temperatures throughout the SmPC and Package leaflet. The updates include a minor correction to the wording of a cross-reference within post-marketing ADR Table 3 in section 4.8, relocation of the footnotes for Tables 13 and 15 in section 5.1 to the bottom of each table and a minor correction to the wording of a subheading in Table 19 in section 5.1. No changes are being made to Zirabev Annex II and Annex IIIA; the updates in these sections of the Avastin Annexes are not applicable to Zirabev.
- Update the description of the pharmacotherapeutic group for the ATC code to align with the Avastin reference SmPC in section 5.1, Pharmacodynamic properties.
-PLENC (name change) for Pfizer Healthcare Ireland to Pfizer Healthcare Ireland unlimited Company.
-Alignment to QRD template v 10.4
Updated on 12 June 2025
File name
Clean Adv PIL bZR 13_0 IE.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 20 November 2023
File name
Clean Adv PIL bZR 12_0 IE NI.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 14 November 2023
File name
Clean Adv SPC bZR 12_0 IE.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
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 November 2023
File name
Clean Adv PIL bZR 11_0 IE NI Copy.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 13 November 2023
File name
Clean Adv SPC bZR 12_0 IE.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 November 2023
File name
Clean Adv SPC bZR 12_0 IE.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 November 2023
File name
Clean Adv PIL bZR 11_0 IE NI Copy.pdf
Reasons for updating
- Change to section 3 - how to take/use
Updated on 20 December 2022
File name
Adv PIL bZR 10_0 IE NI.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 19 December 2022
File name
CleanAdvSPCbZR110IE.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 14 December 2022
File name
CleancopyAdvSPCbZR110IE.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 14 December 2022
File name
cleancopyAdvPILbZR100IENI (1).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 04 August 2022
File name
Adv SPC bZR 10_0 IE clean.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
Adv PIL bZR 9_0 IE NI clean.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
Adv SPC bZR 9_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)
Updated on 10 November 2021
File name
Adv PIL bZR 8_0 IE & NI - clean.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.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.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.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.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.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.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.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.
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.
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.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.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.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.pdf
Reasons for updating
- New PIL for new product
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363