Trazimera - 150mg & 420mg powder 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 23 July 2026
File name
Adv_SPC_bTR_13_0_IE_-_clean_FIXED and with amended date.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)
Free text change information supplied by the pharmaceutical company
Change to section 2 - Qualitative and quantitative composition ; Change to section 4.4 - Special warnings and precautions for use
Updated on 17 July 2026
File name
Adv_SPC_bTR_13_0_IE_-_clean_FIXED.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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 2: details of “Excipient with known effect” added
Section 4.4: information on “Excipient with known effect” added
Updated on 15 July 2026
File name
Adv PIL bTR 17_0 IE - clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- 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 as follows:
Section 2:
- the sub-heading “Pregnancy” updated to “Pregnancy and breast-feeding”
- the sub-header “Breast-feeding” deleted
- New information with sub-header “Trazimera contains polysorbate” added
Section 4: Format of the ADRs mentioned under frequency common retified
Section 6: “(see section 2 “Trazimera contains polysorbate”)” added
Updated on 10 July 2026
File name
Adv PIL bTR 17_0 IE - clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- 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 as follows:
Section 2:
- the sub-heading “Pregnancy” updated to “Pregnancy and breast-feeding”
- the sub-header “Breast-feeding” deleted
- New information with sub-header “Trazimera contains polysorbate” added
Section 4: Format of the ADRs mentioned under frequency common retified
Section 6: “(see section 2 “Trazimera contains polysorbate”)” added
Updated on 05 February 2026
File name
Adv PIL bTR 16_0 IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change of distributor details
Updated on 07 February 2025
File name
Adv SPC bTR 12_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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: section 5. 1 updated ema website link
Updated on 07 February 2025
File name
Adv PIL bTR 15_0 IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 26 January 2024
File name
Adv PIL bTR 14_0 IE NI.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 March 2023
File name
Adv SPC bTR 11_0 IE.pdf
Reasons for updating
- 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 24 March 2023
File name
Adv PIL bTR 13_0 IE NI.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Removal of Black Inverted Triangle
Updated on 14 October 2022
File name
Adv SPC bTR 10_0 IE.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 30 November 2021
File name
Adv SPC bTR 9_0 IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- 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 30 November 2021
File name
Adv PIL bTR 12_0 IE & NI clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 11 October 2021
File name
Adv PIL bTR 11_0 IE & NI clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Joint PIL superseded by individual PILs
- Change of distributor details
Updated on 15 April 2021
File name
DEC202122959_Adv SPC bTR 8_0 IE clean.pdf
Reasons for updating
- 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 15 April 2021
File name
DEC202122959_Adv PIL bTR 10_0 IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 26 February 2021
File name
DEC202113099_Adv PIL bTR 9_0 IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 21 January 2021
File name
DEC202103518_Adv SPC bTR 7_0 IE.pdf
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 January 2021
File name
DEC202103518_Adv PIL bTR 8_0 IE.pdf
Reasons for updating
- Change to section 2 - driving and using machines
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change of distributor details
Updated on 21 January 2021
File name
DEC202103854_Adv PIL bTR 8_0 NI.pdf
Reasons for updating
- Change to section 2 - driving and using machines
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change of distributor details
Updated on 18 February 2020
File name
DEC202008059_Adv SPC bTR 6_0 UK & IE.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
1. Update to section 6.3 shelf life:
addition of aseptic reconstitution and dilution activities.
Change from "24 hours at temperatures not exceeding 30°C." to "up to 30 days at 2°C – 8°C and 24 hours at temperatures not exceeding 30°C."
2. Update to section 6.4 to clarify storage conditions of unopened vial
3. Update to section 6.6 with additional aseptic preparation, handling and storage activities
Updated on 18 February 2020
File name
DEC202008059_Adv PIL bTR 7_0 IE.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 06 December 2019
File name
DEC201968577_Adv PIL bTR 6_0 IE.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 08 August 2019
File name
DEC201938984_clean Adv PIL bTR 5_1 IE_1.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 07 August 2019
File name
DEC201938984_clean Adv SPC bTR 5_1 UK & IE.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 May 2019
File name
clean Adv PIL bTR 4_0 IE.pdf
Reasons for updating
- New PIL for new product
Updated on 01 May 2019
File name
clean Adv SPC bTR 4_0 UK & IE_1.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Product launched in Ireland on 01/05/2019
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