Zirabev 25 mg/ml concentrate for solution for infusion * Pharmacy Only: Prescription
Company:
Pfizer Healthcare IrelandStatus:
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 20 November 2023
File name
655b61e01f211.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 14 November 2023
File name
65537ec1a1855.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
65537ada7e8ea.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
655243eb0f78b.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
655243eb0f78b.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
655243c9ce554.pdf
Reasons for updating
- Change to section 3 - how to take/use
Updated on 20 December 2022
File name
63a1e60bcca57.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
63a01bb4ce4b6.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
6399ec2a25887.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
6399ead69b8e6.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
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