Bavencio 20 mg/mL concentrate for solution for infusion * Pharmacy Only: Prescription
Company:
Merck - PfizerStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 27 April 2022
File name
IRL and NI - SPC Bavencio - ATC code update TW 3377004 - Apr2022 - en CLEAN v13_1651067967.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_1643123887.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_1643123450.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_1636458988.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_1636112927.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_1636112792.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_1611678412.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_1611678282.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 Info Brochure A5 Ireland Sept2020 v1_1602496034.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Updated with immune-related adverse event myasthenia gravis
File name
Bavencio Patient alert card 55x85mm Ireland Sept2020 v1_1602496034.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_1601383201.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_1601382994.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
File name
MCC Bavencio Patient Info Brochure A5 Ireland Nov19 v2_1575294803.pdf
Reasons for updating
- Replace File
Updated on 31 October 2019
File name
PIL RCC_1572521281.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_1572521052.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 Info Brochure A5 Ireland July19 v2 - Panc_1564056319.pdf
Reasons for updating
- Replace File
File name
Final MCC Bavencio Patient alert card 55x85mm Ireland Jul19 v2 - Panc_1564056304.pdf
Reasons for updating
- Replace File
Updated on 08 July 2019
File name
Bavencio - Package leaflet - Panctreatitis - TW1972347_1562576354.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_1562323520.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
Bavencio Patient Info Brochure A5 Ireland v4_1559296190.pdf
Reasons for updating
- Add New Doc
File name
Patient alert card 55x85mm Ireland v4_1559296145.pdf
Reasons for updating
- Add New Doc
Updated on 09 April 2019
File name
Bavencio_corrigendum_PIL_1554816824.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_1550226543.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_1537429420.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