Alofisel 5 million cells/mL suspension for injection
- Name:
Alofisel 5 million cells/mL suspension for injection
- Company:
Takeda Products Ireland Ltd
- Active Ingredients:
- 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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Takeda Products Ireland Ltd
Company Products
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
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