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: 21/12/20

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Summary of Product Characteristics last updated on medicines.ie: 21/12/2020
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.

Click on this link to Download PDF directly

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 21 December 2020 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

MARKETING AUTHORISATION HOLDER

Takeda Pharma A/S

Delta Park 45

2665 Vallensbaek Strand 

Denmark

Dybendal Alle 10

2630 Taastrup

Denmark

 

 

Manufacturer

TiGenix S.A.U.

C/Marconi 1

Parque Tecnológico de Madrid

28760 Tres Cantos, Madrid

Spain

Tel: +34 91 804 92 64

Fax: +34 91 804 92 63

info@tigenix.com

 

 

This leaflet was last revised in 01 November 2020.

Updated on 21 December 2020 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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

5.1     Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants{not yet assigned}, ATC code: {not yet assigned}L04AX08.

 

7. MARKETING AUTHORISATION HOLDER

 

Takeda Pharma A/S

Delta Park 45

2665 Vallensbaek Strand 

Denmark

 

Dybendal Alle 10

2630 Taastrup

Denmark

 

10. DATE OF REVISION OF THE TEXT

 

24 January 06 November 2020

Updated on 21 December 2020 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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

5.1     Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants{not yet assigned}, ATC code: {not yet assigned}L04AX08.

 

7. MARKETING AUTHORISATION HOLDER

 

Takeda Pharma A/S

Delta Park 45

2665 Vallensbaek Strand 

Denmark

 

Dybendal Alle 10

2630 Taastrup

Denmark

 

10. DATE OF REVISION OF THE TEXT

 

24 January 06 November 2020

Updated on 6 February 2020 PIL

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 6 February 2020 SPC

Reasons for updating

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

Updated on 14 October 2019 SPC

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 SPC

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 SPC

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 SPC

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

5.1 - Pharmacodynamic properties needs updating