Medicine information ALOFISEL 5x10^6 CELULE/ml 5 x 10{6} celule / ml dispersion for injection

Product code:
W64494001
Quantity:
1
Indicated for:
complex perianal fistulas in Crohn's disease
Route of administration:
injectable
Substance:
darvadstrocel (cell therapy)
ATC
L04AX08 — Antineoplastic and immunomodulating agents | Immunosuppressants | Immunosuppressants | Other immunosuppressants
Darvadstrocel is a cell therapy product used for the treatment of complex perianal fistulas in patients with Crohn's disease. It contains mesenchymal stem cells derived from adipose tissue, which have anti-inflammatory and regenerative properties.

The medication is administered via direct injection into the affected tissues, and the procedure is performed by a specialist. Common side effects include pain at the injection site, fever, and local inflammatory reactions.

Darvadstrocel is contraindicated in patients with active infections or hypersensitivity to any of the product's components. Its use also requires careful monitoring to prevent complications.

This medication is an innovative option for patients with complex perianal fistulas, helping to reduce inflammation and promote tissue healing.

General data about ALOFISEL 5x10^6 CELULE/ml 5 x 10{6} celule / ml

Substance:
darvadstrocel
Date of latest medicines list:
01-02-2025
Product code:
W64494001
Strength:
5 x 10{6} celule / ml
Pharmaceutical form:
dispersion for injection
Quantity:
1
Product type:
Original
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
TIGENIX, S.A.U. - SPANIA
Holder:
TAKEDA PHARMA A/S - DANEMARCA
Number:
1261/2018/01
Shelf life:
48 hours

Pharmaceutical forms available for darvadstrocel

Strengths available for darvadstrocel

  • 30millions of cells/6ml
  • 5 x 10{6} celule/ml

Official documents

The SmPC text is not displayed because a match to this medicine, strength and pharmaceutical form has not been confirmed.

Added to database:
04/04/2018
Source record updated:
21/01/2025