Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1768226
Name of medicinal product: ALOFISEL
Active substances:
Darvadstrocel
Estonian, English, Latin
ATC code: L04AX08
Dosage form: suspension for injection
Route of administration: intralesional use
Strengh: 5000000bakterirakku 1ml
Amount in package: 6ml 4TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with nonactive/ mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula, see section 4.2.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Takeda Pharma A/S 
Marketing authorization number: EU/1/17/1261 
Marketing authorization issued on: March 27, 2018 
Marketing authorization expires on: March 27, 2023 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 28, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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