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: 29/09/20
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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 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
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
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
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
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
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
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
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Updated on 20 September 2018
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
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
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
Reasons for updating
- New SmPC 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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