Briviact 10mg/ml oral solution *

  • Company:

    UCB (Pharma) Ireland Limited
  • Status:

    No Recent Update
  • Legal 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

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 November 2020

File name

ie-briviact-osl-clean_1606381821.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 _1602582234.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_1578662299.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_1602581870.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_1578662299.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_1578662172.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_1563972371.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_1533136331.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_1533136440.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

  • 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 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 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

None provided

Updated on 24 June 2016

Reasons for updating

  • New PIL for new product