Zirabev 25 mg/ml concentrate for solution for infusion
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal 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 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