Alofisel 5 million cells/mL suspension for injection *

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 June 2021

File name

Alofisel-PIL-UK and Ireland_Nov 2020_1623683514.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

The following wording in blue has been added:

 

2. What you need to know before you are given Alofisel

Warnings and precautions

Talk to your doctor or surgeon before you are given Alofisel.

Alofisel may contain traces of either gentamicin or benzylpenicillin or and streptomycin (antibiotics). This should be considered if you are allergic to these antibiotics, as these antibiotics are used in the manufacturing process of this medicine….

Updated on 14 June 2021

File name

Alofisel-SPC-ire-November 2020_1623683029.pdf

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

In section 4.4, the following wording in blue has been added:


Alofisel may contain trace amounts of either gentamicin or benzylpenicillin and streptomycin. This should be considered in patients with known hypersensitivity to these classes of antibiotics….

Updated on 21 December 2020

File name

Alofisel (darvadstrocel) SmPC IRE 06 Nov 2020_1608552523.pdf

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

File name

Alofisel (darvadstrocel) SmPC IRE 06 Nov 2020_1608552508.pdf

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 06 February 2020

File name

Alofisel (darvadstrocel) PIL IRE 20.01.2020_1581002642.pdf

Reasons for updating

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

Updated on 06 February 2020

File name

Alofisel (darvadstrocel) SmPC IRE 20.01.2020_1581002573.pdf

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

File name

Alofisel (darvadstrocel) SmPC IRE 07.10.2019_1571085285.pdf

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

File name

Alofisel (darvadstrocel) SmPC IRE 10.10.2019_1570996104.pdf

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

File name

Alofisel (darvadstrocel) PIL IRE 05.04.2019_1556116752.pdf

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

File name

Alofisel (darvadstrocel) SmPC IRE 05.04.2019_1556035656.pdf

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

File name

Alofisel (darvadstrocel) PIL IRE 05.2018.pdf

Reasons for updating

  • New PIL for new product

Updated on 25 May 2018

File name

Alofisel (darvadstrocel) SmPC IRE 08.05.2018.docx

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