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Truxima 100 mg and 500 mg concentrate for solution for infusion

  • Name:

    Truxima 100 mg and 500 mg concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Rituximab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/08/19

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Summary of Product Characteristics last updated on medicines.ie: 7/8/2019
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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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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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 8 August 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects

Updated on 7 August 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

The SmPC has been updated as follows:

- Addition of Pemphigus Vulgaris indication

- Extension of the GPA/MPA indications

- Update of the final results of the PRIMA study

- Update of the sodium content

Updated on 27 June 2019 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

In use stability shelf-life

Updated on 21 December 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company

Correction to Qualitative and quantitative composition to say Each mL of concentrate contains 10 mg of rituximab. for the 500 mg concentrate as well asthe 100 ml.

Updated on 10 December 2018 PIL

Reasons for updating

  • Change to section 6 - what the product contains
  • Individual PILs superseded by joint PIL

Updated on 8 December 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change from individual to joint SmPC

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

Free text change information supplied by the pharmaceutical company

Shelife increased

Updated on 21 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 February 2018 PIL

Reasons for updating

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

Updated on 19 February 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 19 February 2018 SmPC

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)

Free text change information supplied by the pharmaceutical company

Section 7$0Change of address for the marketing authorisation holder$0$0$0$0$0Section 10$0$0Updated in date of revision to '26 January 2018'$0

Updated on 10 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 January 2018 SmPC

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