Bavencio 20 mg/mL concentrate for solution for infusion
*Company:
MerckStatus:
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 28 April 2025
File name
IE-PIL Bavencio-neutropenia _CCDS12_TW 4787368_Apr2025 Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
The proposed changes are as follows:
To add the immune-mediated adverse reaction neutropenia in section 4.8 of spc. to implement the new statement relating to the polysorbate excipient in the avelumab patient information leaflet
Internal reference number: TW 4787368
Updated on 28 April 2025
File name
IE-SPC Bavencio-neutropenia _CCDS12_TW 4787368_Apr2025 Clean v20.pdf
Reasons for updating
- 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 proposed changes are as follows:
To add the immune-mediated adverse reaction neutropenia in section 4.8 of spc. to implement the new statement relating to the polysorbate excipient in the avelumab patient information leaflet
Internal reference number: TW 4787368
Updated on 26 March 2025
File name
IE-Bavencio PIL - Renewal-CCDS10-11-TW4571968 TW4794124 - Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
The proposed changes are as follows:
To add the immune-mediated adverse reactions sclerosing cholangitis, arthritis, polymyalgia rheumatica, and Sjogren's syndrome in SmPC section 4.2, 4.4, 4.6 and PL section 2 and 4
· To correct and to update the information for immunogenicity in SmPC section 4.8 immunogenicity.
The marketing authorisation which expires on 25 August 2025 has been renewed with unlimited validity.
SPC and PIL changes are only administrative and will be introduced with next week safety variation approval
Internal reference number: CCDS 10&CCDS11 (TW4571968), RENEWAL (TW 4794124)
Updated on 26 March 2025
File name
IE-SPC Bavencio-Renewal-CCDS v10-11 TW4571968 TW4794124-Mar2025-Clean v19.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 - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 proposed changes are as follows:
To add the immune-mediated adverse reactions sclerosing cholangitis, arthritis, polymyalgia rheumatica, and Sjogren's syndrome in SmPC section 4.2, 4.4, 4.6 and PL section 2 and 4
· To correct and to update the information for immunogenicity in SmPC section 4.8 immunogenicity.
The marketing authorisation which expires on 25 August 2025 has been renewed with unlimited validity.
SPC and PIL changes are only administrative and will be introduced with next week safety variation approval
Internal Reference number: CCDS 10&CCDS11 (TW4571968), Renewal (TW 4794124)
File name
CLEAN Bavencio Patient alert card 55x85mm Ireland Oct2024 v4_APPROVED.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Objectives and rationale for educational materials:
Revision of RMP v 7.2 as a consequence of the PRAC recommendation and assessment report issued on 26 Oct 2023, (approved in EU in July 2024) introduced following changes:
· removal of the patient information brochure from the educational material
· removal of black triangle
· update the statement for “infusion-related reactions to align terminology with the EU RMP for the term “immune-related” versus “immune-mediated”
· some additional editorial changes proposed by the MAH.
Brief description of educational tools/materials proposed:
Patient Alert Card
Updated on 21 August 2024
File name
IRL and NI - SPC Bavencio_ RMP update TW4380807 -JUL2024 - Clean v18.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 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
- 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 21 August 2024
File name
IRL&NI - Bavencio PIL - RMP update - TW 4380807 v5 - CLEAN.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
- Removal of Black Inverted Triangle
Updated on 08 July 2024
File name
IRL&NI - Bavencio PIL - PRAC- TW 4512890 v4 - CLEAN.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 08 July 2024
File name
IRL and NI - SPC Bavencio_PRAC TW 4512890 -MAY 2024 - Clean v17.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 19 June 2024
File name
IRL and NI - SPC Bavencio_PRAC TW 4512890 -MAY 2024 - Clean v17.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 19 June 2024
File name
IRL&NI - Bavencio PIL - PRAC- TW 4512890 v4 - CLEAN.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 17 January 2024
File name
IRL&NI - Bavencio PIL - PSUSA- TW4290907 v3 - CLEAN.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 12 January 2024
File name
IRL and NI - SPC Bavencio_PSUSA-202303-JAN 2024 - Clean v16.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
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 January 2023
File name
IRL and NI - SPC Bavencio - in use stab TW - DEC 2022 - clean v15.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Update of section 6.3 of the SmPC with regard to in-use stability.
Our reference: TW3812572
Updated on 03 January 2023
File name
IRL and NI - SPC Bavencio - in use stab TW - DEC 2022 - clean v15.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Update of section 6.3 of the SmPC with regard to in-use stability.
Our reference: TW3812572
Updated on 24 October 2022
File name
IRL and NI - SPC Bavencio - ped study TW 3675813 - SEPT 2022 - CLEAN v14.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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
To update the SmPC in sections 4.2, 5.1 and 5.2 with the results from paediatric study
Our reference: TW3675813
File name
BAVENC~2.PDF
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Educational materials for Bavencio have been updated to include additional signs and symptoms of the immune-related adverse reaction of Type 1 diabetes, including diabetes ketoacidosis.
Our reference: TW3202899
Updated on 27 April 2022
File name
IRL and NI - SPC Bavencio - ATC code update TW 3377004 - Apr2022 - en CLEAN v13.pdf
Reasons for updating
- 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
Update of ATC code to L01FF04
Our reference: TW3377004
Updated on 25 January 2022
File name
IRL&NI - Bavencio PIL - T1D - TW3202899 - v2 - CLEAN.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to Type-I-diabetes statements in the PIL (section 2 & 4).
Our reference: TW3202899
Updated on 25 January 2022
File name
IRL and NI - SPC Bavencio - immunogenicity - TW3202899 - Jan2022 - en CLEAN v12.pdf
Reasons for updating
- 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
Immunogenicity update (section 4.8)
Our reference: TW3202899
Updated on 09 November 2021
File name
IRL and NI - SPC Avelumab - Osmolality - TW3153718 - Oct 2021 - en CLEAN - v11.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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
Osmolality SPC update in section 3
Our reference: TW3153718
Updated on 05 November 2021
File name
IRL&NI - Bavencio SPC - PRAC cystitis - TW3094611 - Sept 2021 - current v10 - CLEAN.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
PRAC recommendation - Cystitis
Our reference: TW 3094611
Updated on 05 November 2021
File name
IRL&NI - Bavencio PIL - PRAC rec - TW3094611 - v1 - CLEAN.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PRAC recommendation - Cystitis
Our reference: TW3094611
Updated on 26 January 2021
File name
Bavencio PIL - TW2494580, TW2669961 - Jan 2021 - clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Changes include: Addition of new indication - urothelial carcinoma (UC) & shelf life extension to 3 years.
Our ref: TW2494580, TW2669961
Updated on 26 January 2021
File name
Bavencio SPC 20mgml UK&IE TW2494580 TW2669961 current v9.0 - 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- 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
Changes include: Addition of new indication - urothelial carcinoma (UC) & shelf life extension to 3 years.
Our ref: TW2494580, TW2669961
File name
Bavencio Patient alert card 55x85mm Ireland Sept2020 v1.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Updated with immune-related adverse event myasthenia gravis
Updated on 29 September 2020
File name
Bavencio 20mgml UK&IE TW2351837 TW2263689 PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- Addition of myasthenia gravis as an immune-related adverse event
- Removal of the ‘conditional’ status of the Marketing Authorisation
Our ref:
TW2351837
TW2263689
Updated on 29 September 2020
File name
Bavencio 20mgml UK&IE TW2351837 TW2263689 TW2350918 current v8.0.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 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Addition of myasthenia gravis as an immune-related adverse event
- Addition of MCC ‘Part B’ data (specific obligation) and removal of the ‘conditional’ status of the Marketing Authorisation in section 5.1
- 3rd annual renewal of the Marketing Authorisation
Our ref:
TW2351837
TW2263689
TW2350918
Updated on 31 October 2019
File name
PIL RCC.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 31 October 2019
File name
Bavencio 20mgml UK&IE TW1972145 current v7.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 4.8 - 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 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Final MCC Bavencio Patient alert card 55x85mm Ireland Jul19 v2 - Panc.pdf
Reasons for updating
- Replace File
Updated on 08 July 2019
File name
Bavencio - Package leaflet - Panctreatitis - TW1972347.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 05 July 2019
File name
Bavencio 20mgml UK&IE TW1972347 current v6.0.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 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Patient alert card 55x85mm Ireland v4.pdf
Reasons for updating
- Add New Doc
Updated on 09 April 2019
File name
Bavencio_corrigendum_PIL.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 15 February 2019
File name
Bavencio 20mgml UK&IE TW1971395 current v5.0.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 September 2018
File name
Bavencio 20mgml UK and IE TW1767401 current v4.0.pdf
Reasons for updating
- 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)
Updated on 17 July 2018
File name
PIL_17313_183.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 17 July 2018
File name
Bavencio 20mgml UK and IE TW1735675 current v3.0 (002).docx
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)
Updated on 03 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 03 January 2018
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- 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
5.1 Pharmacodynamic properties- ATC code has changed from not yet assigned to L01XC31.
6.3 Shelf life - Under, After preparation of infusion, '(see section 6.6)' has been removed.
6.6 Special precautions for disposal and other handling - 'The diluted solution must not be stored longer than a total of 24 hours under refrigerated conditions, (2°C to 8°C) or up to 8 hours at room temperature (20°C to 25°C)' has been removed.
10. DATE OF REVISION OF THE TEXT - has changed to 12/2017
Updated on 02 January 2018
File name
PIL_17313_183.pdf
Reasons for updating
- New PIL for new product
Updated on 02 January 2018
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 27 September 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 27 September 2017
Reasons for updating
- New PIL for new product
Merck
Address:
Merck Serono (Ireland) Limited, 4045 Kingswood Road, Citywest Business Campus, Dublin 24, IrelandMedical Information E-mail:
medinfo.uk@merckgroup.comTelephone:
+353 1 468 7590Fax:
+353 1 466 3446Medical Information Facsimile:
+44 (0)208 818 7274Medical Information Direct Line:
+44 (0)208 818 7373