Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark
Alofisel 5 million cells/mL suspension for injection.
| Pharmaceutical Form |
|---|
|
Suspension for injection. The suspension of cells may have settled in the bottom of the vial forming a sediment. After gentle re-suspension, the product is a white to yellowish homogeneous suspension. |
Darvadstrocel is expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (expanded adipose stem cells – eASC).
Each vial contains a suspension of 30 million cells (eASC) in 6 mL solution, corresponding to a concentration of 5 million cells/mL.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Darvadstrocel |
Darvadstrocel contains expanded adipose stem cells (eASC), which exhibit immunomodulatory and anti-inflammatory effects at inflammation sites. |
| List of Excipients |
|---|
|
Dulbecco’s Modified Eagle´s Medium (DMEM) (containing amino acids, vitamins, salts and carbohydrates) |
Alofisel is supplied as one treatment dose contained in 4 Type I glass vials. Each vial contains 6 mL of eASC suspension and is closed with a rubber stopper and a flip-off seal. The vials are placed inside a cardboard box.
Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark
EU/1/17/1261/001
Date of first authorisation: 23 March 2018
| Drug | Countries | |
|---|---|---|
| ALOFISEL | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Lithuania, Poland, Romania, United Kingdom |
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