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Brintellix 10 mg film-coated tablets

  • Name:

    Brintellix 10 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Vortioxetine hydrobromide

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/12/20

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Summary of Product Characteristics last updated on medicines.ie: 3/12/2020

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Lundbeck (Ireland) Limited

Lundbeck (Ireland) Limited

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Medicine Name Brintellix 10 mg film-coated tablets Active Ingredients Vortioxetine hydrobromide
Medicine Name Brintellix 15 mg film-coated tablets Active Ingredients Vortioxetine hydrobromide
Medicine Name Brintellix 20 mg film-coated tablets Active Ingredients Vortioxetine hydrobromide
Medicine Name Brintellix 5 mg film-coated tablets Active Ingredients Vortioxetine hydrobromide
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Medicine Name Depixol Conc. 100 mg/ml Injection Active Ingredients Flupentixol Decanoate
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Medicine Name Ebixa Tablets Active Ingredients Memantine hydrochloride
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1 - 0 of 25 items.Total: Infinity pages

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 3 December 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects

Updated on 3 December 2020 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 10 July 2020 SPC

Reasons for updating

  • 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 10 July 2020 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect

Updated on 10 March 2020 SPC

Reasons for updating

  • 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

•    The purpose of the first Type II variation is to update the SmPC, section 4.8 and 5.1 to include clinically relevant information for the prescriber and patient describing vortioxetine’s superior (comparative) effect on treatment-emergent sexual dysfunction (TESD) based on the outcome of 2 prospective clinical studies (Studies 318 and 4001).

•    The purpose of the second Type II variation is to update the SmPC, section 4.4 and 5.2 to reflect the outcome of Study 401 that investigated PK, safety, and tolerability in subjects with severe hepatic impairment, as requested by the EMA during the Renewal assessment. In addition, adjustments are also proposed for renal impairment (although there is no new data on renal impairment) to align the wording between hepatic and renal impairment.

Updated on 6 March 2020 SPC

Reasons for updating

  • 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

•    The purpose of the first Type II variation is to update the SmPC, section 4.8 and 5.1 to include clinically relevant information for the prescriber and patient describing vortioxetine’s superior (comparative) effect on treatment-emergent sexual dysfunction (TESD) based on the outcome of 2 prospective clinical studies (Studies 318 and 4001).

•    The purpose of the second Type II variation is to update the SmPC, section 4.4 and 5.2 to reflect the outcome of Study 401 that investigated PK, safety, and tolerability in subjects with severe hepatic impairment, as requested by the EMA during the Renewal assessment. In addition, adjustments are also proposed for renal impairment (although there is no new data on renal impairment) to align the wording between hepatic and renal impairment.
 

Updated on 3 July 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 July 2019 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)