Trumenba suspension for injection in pre-filled syringe
*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 24 February 2025
File name
Adv SPC TU 13_0 IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 September 2024
File name
Adv SPC TU 12_0 IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
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 4.2 to add a directional reference to Section 4.8 for currently available data in infants 2 months of age, and a statement warning against the use in infants aged 2 to 6 months age.
Section 4.4 to addition of sub-headings, inc. a ‘Traceability’ subheading, and an ‘Excipients’ subheading.
Section 4.8 to include the data from study C3511002 on fever, the serious events of fever requiring clinical and laboratory investigations, including lumbar puncture, and CSF pleocytosis, in infants 2 months of age.
Updated on 17 October 2023
File name
AdvPILTU140IENIclean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 08 November 2022
File name
AdvSPCTU110IEclean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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: Sections 4.8 and 5.1 to add immunopersistence and booster data based on final results from study B1971035
Updated on 29 April 2022
File name
Adv SPC TU 10_0 IE clean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 April 2022
File name
Adv PIL TU 13_0 IE NI clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 08 November 2021
File name
Adv PIL TU 12_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
- Change to other sources of information section
- Individual PILs superseded by joint PIL
Updated on 22 June 2021
File name
DEC202141483_Adv PIL TU 11_0 IE clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 22 June 2021
File name
DEC202141483_Adv SPC TU 9_0 IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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 4.4: Addition of text for sodium excipient to indicate contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free’. - Section 4.8: Update to the overall exposure information. - Section 5.1: Addition of the immunogenicity data from Study B1971057 in support of the 2-dose schedule. |
Updated on 29 June 2020
File name
DEC202042744_ADV SPC TU 8_0 IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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:
.\ update of sections 4.2 and 4.8 following results from Article 46 1033 study in children younger than 10 years of age;
.\ update of sections 4.4 and 5.1 with results from Article 46 studies 1033, 1035 and 1017;
.\ minor corrections in section 4.4 and 5.1
.\ splitting of UK and IE versions of the SPC with the removal of the correspondent ADR contact details in section 4.8.
Updated on 29 June 2020
File name
DEC202042744_ADV PIL TU 10_0 IE clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 November 2019
File name
DEC201966415_ADV PIL TU 7_1 IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 20 December 2018
File name
ADV PIL TU 6_0 IE_clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 20 December 2018
File name
ADV SPC TU 5_0 UK IE_clean.pdf
Reasons for updating
- 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:
Update of section 4.4 of the SmPC in order to add a warning about an increased risk of invasive disease caused by Neisseria meningitidis serogroup B in persons with complement deficiencies or using concomitant treatments inhibiting terminal complement activation
Updated on 26 November 2018
File name
ADV SPC TU 4_0 UK IE clean.pdf
Reasons for updating
- Addition of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Please note that TRUMENBA is subject to additional monitoring and therefore an inverted black triangle ≦ has been added to the SPC, PIL and PI.
Updated on 19 November 2018
File name
ADV PIL TU 5_0 IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 19 November 2018
File name
ADV SPC TU 4_0 UK IE clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
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 6.3 is update with the new shelf-life.
Updated on 14 November 2018
File name
ADV PIL TU 4_0 UK IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 14 November 2018
File name
ADV SPC TU 3_0 UK IE clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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|;
SECTION 7 – Change to MAH
SECTION 10 – Date of revision of text
Updated on 08 November 2018
File name
ADV PIL TU 5_0 IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 01 October 2018
File name
ADV PIL TU 3_0 UK IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 01 October 2018
File name
ADV SPC TU 3_0 UK IE clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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|;
SECTION 7 – Change to MAH
SECTION 10 – Date of revision of text
Updated on 03 April 2018
File name
PIL_17167_330.pdf
Reasons for updating
- New PIL for new product
Updated on 03 April 2018
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 17 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 January 2018
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
Syncope included in section 4.4
Booster AE statement added in section 4.8
Interchangeability statement added in section 4.2
MHRA AE reporting statement updated in section 4.8
Updated on 16 January 2018
File name
PIL_17167_855.pdf
Reasons for updating
- New PIL for new product
Updated on 16 January 2018
Reasons for updating
- Change to section 6 - date of revision
Updated on 31 May 2017
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
Updated on 30 May 2017
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