Bavencio 20 mg/mL concentrate for solution for infusion
- Name:
Bavencio 20 mg/mL concentrate for solution for infusion
- Company:
Merck - Pfizer
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/01/21
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Merck - Pfizer
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name Bavencio 20 mg/mL concentrate for solution for infusion | Active Ingredients Avelumab |
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 26 January 2021 PIL
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 SPC
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
Updated on 12 October 2020 Ed-Ptnt
Reasons for updating
- Replace document
Free text change information supplied by the pharmaceutical company
Updated with immune-related adverse event myasthenia gravis
Updated on 12 October 2020 Ed-Ptnt
Reasons for updating
- Replace document
Free text change information supplied by the pharmaceutical company
Updated with immune-related adverse event myasthenia gravis
Updated on 29 September 2020 PIL
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 SPC
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 2 December 2019 Ed-Ptnt
Reasons for updating
- Replace document
Updated on 31 October 2019 PIL
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 SPC
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)
Updated on 25 July 2019 Ed-Ptnt
Reasons for updating
- Replace document
Updated on 25 July 2019 Ed-Ptnt
Reasons for updating
- Replace document
Updated on 8 July 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 5 July 2019 SPC
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)
Updated on 7 June 2019 Ed-Ptnt
Reasons for updating
- Add New Doc
Updated on 7 June 2019 Ed-Ptnt
Reasons for updating
- Add New Doc
Updated on 9 April 2019 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 15 February 2019 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 17 July 2018 SPC
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 3 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 3 January 2018 SPC
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 2 January 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 2 January 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 27 September 2017 SPC
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 PIL
Reasons for updating
- New PIL for new product
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