TRUMENBA

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Pharmacy Only: Prescription

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  • Individual PILs superseded by joint PIL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

The SPC has been updated as follows:> <

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

None provided

Updated on 30 May 2017

Reasons for updating

  • New PIL for new product