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Alofisel 5 million cells/mL suspension for injection

  • Name:

    Alofisel 5 million cells/mL suspension for injection

  • Company:
    info
  • Active Ingredients:

    Human Allogeneic Mesenchymal Adult Stem Cells

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/04/19

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Summary of Product Characteristics last updated on medicines.ie: 14/10/2019
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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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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Medicine Name Alofisel 5 million cells/mL suspension for injection Active Ingredients Human Allogeneic Mesenchymal Adult Stem Cells
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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 14 October 2019 SmPC

Reasons for updating

  • 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

Shelf Life (section 6.3) changed from 48 hours to 72 hours.

Date of revision updated to 07 October 2019

Updated on 13 October 2019 SmPC

Reasons for updating

  • 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

SmPC

  • Section6.3 (Shelf-life)  - changed from 48 hours to 72 hours
  • section 10 (Date of Revision) – changed to 10 October 2019

 

PIL and labelling – not affected

Updated on 24 April 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 23 April 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 4.3 - Contraindications
  • 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 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 9 - Date of first authorisation/renewal of the authorisation
  • 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 29 May 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 May 2018 SmPC

Reasons for updating

  • New SmPC 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

5.1 - Pharmacodynamic properties needs updating