Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion

  • Name:

    Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Belimumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/11/19

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Summary of Product Characteristics last updated on medicines.ie: 1/11/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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1 - 0 of 136 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 1 November 2019 SmPC

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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 1 November 2019 PIL

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 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 July 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 July 2019 SmPC

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 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

Section 4.4 - warnings and precaution of use as studies show psychiatric disorders reported in patients receiving Benlysta
section 4.8 - clarity on safety profile
Section 4.8 - addition of Suicidal behaviour and suicidal ideation as an uncommon side effect
section 4.8 - inclusion of clinical findings for psychiatric disorders
section 5.1 - inclusion of studies in Black patients
Section 10 - revision date updated
 

Updated on 30 November 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 30 November 2018 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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)

Free text change information supplied by the pharmaceutical company

Section 6: MAH Name and address updated from Glaxo Group Limited to GlaxoSmithKline (Ireland) Limited.

Section 4.8: The combined UK/IE SPC has been split into individual market SPCs and thus the reporting details have been updated to reflect this.

Updated on 1 June 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 May 2018 SmPC

Reasons for updating

  • Other

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

Updated on 11 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 12 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 February 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Joint PIL superseded by individual PILs

Updated on 27 November 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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

Section 4.2 - Moved paragraph on transitioning from IV to subcutaneous administration
Section 4.5: Addition of interaction information
Section 4.8: Update to summary and description of adverse reactions. Addition of side effects to the table (urinary tract infection, upper respiratory tract infection, injection site reaction, angioedema. Deletion of insomnia.
Section 5.1 - clarity that biomarkers were seen in clinical trials with Benlysta administered intravenously.
Section 5.2: Transitioning from intravenous to subcutaneous administration added.

Updated on 27 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 November 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 September 2016 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose
  • 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

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

Free text change information supplied by the pharmaceutical company

Section 4.9 – Update to product information text in relation to overdose

 

Section 6.3 and 6.6 - update the product information text in relation to compatibility with reconstitution diluents and container closure system and regarding compatibility with needle gauge.

 

Updated on 23 September 2016 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Improved electronic presentation

Updated on 26 July 2016 SmPC

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 - how to report a side effect
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

4.4          Special warnings and precautions for use - infections can be severe and fatal and to consider dose interruption of immunosuppressant therapy

in the midst of acute infection.

4.6          Fertility, pregnancy and lactation - Benlysta should not be used during pregnancy unless the potential benefit justifies the potential risk to

the foetus.

4.8          Undesirable effects - Some infections were severe or fatal.

9.            DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION - 18 February 2016 added.

Updated on 26 July 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision

Updated on 6 July 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

4.4          Special warnings and precautions for use – text added around immunisations and study evaluating the response to a 23-valent pneumococcal vaccine.

Removal of following text: There are insufficient data to draw conclusions regarding the ability of subjects receiving Benlysta to mount protective responses to vaccines.

Updated on 25 June 2014 SmPC

Reasons for updating

  • New SPC for medicines.ie

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 2014 PIL

Reasons for updating

  • New PIL for medicines.ie