Briviact 10mg/ml oral solution
*Company:
UCB (Pharma) Ireland LimitedStatus:
UpdatedLegal 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 November 2024
File name
Briviact OSL - PIL.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 28 November 2024
File name
Briviact OSL - SPC.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 November 2024
File name
Briviact OSL - PIL.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 11 January 2024
File name
Briviact Oral solution PIL-Cleaned -IE.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
Updated on 13 February 2023
File name
IE Briviact OSL_SmPC.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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)
Updated on 13 February 2023
File name
IE Briviact_OSL_PIL.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 28 February 2022
File name
ie-pil-briviact-osl.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Updates to section 1, 2, 3 and 6 of the package leaflet related to the extension of the paediatric indication to paediatric patients from 2 years of age.
Updated on 28 February 2022
File name
ie-spc-briviact-osl.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- 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
Updates to section 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2,6.3, 6.5, 10 related to the extension of the paediatric indication to paediatric patients from 2 years of age.
Updated on 24 November 2021
File name
ie-spc-briviact-osl.pdf
Reasons for updating
- Change to section 4.9 - Overdose
- 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- Overdosing (Update of section 4.9)
Updated on 24 November 2021
File name
ie-pl-briviact-osl.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PRAC Recommendation- Overdosing (Update of section 3)
Updated on 26 November 2020
File name
ie-briviact-osl-clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 SmPC section 4.5 to reflect data on coadministration with cannabidiol following PSUR Procedure |
Updated on 13 October 2020
File name
PIL OSL .pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Change to section 2 - what you need to know - contraindications Change to section 2 - pregnancy, breast feeding and fertility Change to section 6 - what the product contains Change to section 6 - date of revision Removal of Black Inverted Triangle
Updated on 13 October 2020
File name
IE PIL - Briviact 10mg_ml oral solution CLEAN.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 13 October 2020
File name
SPC OSL.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- 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
- Removal 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
2020 Renewal, editorial updates and excipient warning update in line with EU guidelines
Updated on 10 January 2020
File name
IE PIL - Briviact 10mg_ml oral solution CLEAN.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Extension of shelf life for Oral solution and Solution for injection;
Implementing the new statements for excipients listed in the revised Annex to the European Commission guideline on "Excipients in the labelling and package
leaflet of medicinal products for human use" (SANTE-2017-11668) in the relevant sections of the SmPC, Labelling and Package Leaflet, as appropriate.
Updated on 10 January 2020
File name
IE SPC - Briviact 10 mg_ml oral solution CLEAN.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- 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
Extension of shelf life for Oral solution and Solution for injection;
Implementing the new statements for excipients listed in the revised Annex to the European Commission guideline on "Excipients in the labelling and package
leaflet of medicinal products for human use" (SANTE-2017-11668) in the relevant sections of the SmPC, Labelling and Package Leaflet, as appropriate.
Updated on 24 July 2019
File name
master-pi-briviact-osl.pdf
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 August 2018
File name
Briviact 10mgml oral solution PIL IE.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 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 01 August 2018
File name
Briviact 10 mgml oral solution SPC IE.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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
- 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 concerning the approval of Briviact in paediatric patients (>=4 years old)
Sections:
4.1. Therapeutic indications;4.4 Special warnings and precautions for use;4.8 Undesirable effects;5.1 Pharmacodynamic properties;5.2 Pharmacokinetic properties;10 Date of revision of the text
Updated on 18 July 2018
File name
Briviact 10mgml oral solution.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
Updated on 26 April 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 April 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- 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
4.5 Interaction with other medicinal products and other forms of interaction
Editorial change
4.8 Undesirable effects
Type I hypersensitivity (Immune system disorders -Uncommon)
Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.
5.2 Pharmacokinetic properties
Biotransformation
[…] Both metabolites, are further metabolised forming a common hydroxylated acid formed predominantly by hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9). […]
Updated on 24 April 2017
File name
PIL_16766_380.pdf
Reasons for updating
- New PIL for new product
Updated on 24 April 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 March 2017
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Previous version of SPC reinstated
Updated on 23 March 2017
Reasons for updating
- Previous version of PIL reinstated
Updated on 28 February 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
In section 4.8 (undesirable effects), Type I hypersensitivity has been added with uncommon frequency
And the description of the above mentioned adverse reaction has been added as follow “Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.”
In section 5.2 (Biotransformation): “[…] Both metabolites, are further metabolised forming a common hydroxylated acid formed predominantly by hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9).”
Updated on 27 February 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 December 2016
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 24 June 2016
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 24 June 2016
Reasons for updating
- New PIL for new product