Alofisel 5 million cells/mL suspension for injection * Pharmacy Only: Prescription
Company:
Takeda Products Ireland LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 13 January 2023
File name
63c18ede60c9b.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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 13 January 2023
File name
63c18e0be41a6.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
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